Conditions Treated

Back Clinic Conditions Treated. Chronic Pain, Auto Accident Care, Back Pain, Low Back Pain, Back Injuries, Sciatica, Neck Pain, Work Injuries, Personal Injuries, Sports Injuries, Migraine Headaches, Scoliosis, Complex Herniated Discs, Fibromyalgia, Wellness & Nutrition, Stress Management, and Complex Injuries.

At El Paso’s Chiropractic Rehabilitation Clinic & Integrated Medicine Center, we are focused on treating patients after debilitating injuries and chronic pain syndromes. We focus on improving your ability through flexibility, mobility, and agility programs tailored for all age groups and disabilities.

If Dr. Alex Jimenez feels you need other treatment, then you will be referred to a clinic or Physician that is best suited for you. Dr. Jimenez has teamed with the top surgeons, clinical specialists, medical researchers, and premiere rehabilitation providers to bring El Paso the top clinical treatments to our community. Providing the top non-invasive protocols is our priority. Clinical insight is what our patients demand in order to give them the appropriate care required. For answers to any questions you may have please call Dr. Jimenez at 915-850-0900

Herniated Disc & Sciatica Nonoperative Treatment in El Paso, TX

by spinedoctors | Conditions Treated, Herniated Disc, Randomized Controlled Trial, Research Studies, Sciatica, Spinal Decompression Treatments, Treatments

A herniated disc, also known as a slipped or ruptured disc, is a healthcare condition which occurs when a tear in the outer, fibrous ring of an intervertebral disc causes its soft, central portion to bulge out from the damaged, surrounding cartilage. Disc herniations are generally due to the degeneration of the outer ring of an intervertebral disc, known as the anulus fibrosus. Trauma, lifting injuries or straining may also cause a herniated disc. A tear in the intervertebral disc may result in the release of chemicals which may cause irritation and ultimately become the direct cause of severe back pain, even without nerve root compression.

Disc herniations also commonly develop following a previously existing disc protrusion, a healthcare condition in which the outermost layers of the anulus fibrosus remain intact, however, these can bulge if the disc is placed under pressure. Unlike a disc herniation, none of the gel-like section escapes the intervertebral disc. Herniated discs often heal on their own within several weeks. Severe disc herniations may require surgery, however, a variety of research studies have demonstrated that nonoperative treatment may help improve and manage the recovery process of a herniated disc without the need for surgical interventions.

Surgical vs Nonoperative Treatment for Lumbar Disk Herniation Using The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial

Name: El Paso Back Clinic | Spine Specialists - El Paso, TX
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Abstract

Context: Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.
Objective: To assess the efficacy of surgery for lumbar intervertebral disk herniation.
Design, Setting, and Patients: The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.
Interventions: Standard open diskectomy vs nonoperative treatment individualized to the patient.
Main Outcome Measures: Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.
Results: Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.
Conclusions: Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.
Trial Registration: clinicaltrials.gov Identifier: NCT00000410

Lumbar diskectomy is the most common surgical procedure performed in the United States for patients having back and leg symptoms; the vast majority of the procedures are elective. However, lumbar disk herniation is often seen on imaging studies in the absence of symptoms[1,2] and can regress over time without surgery.[3] Up to 15-fold variation in regional diskectomy rates in the United States[4] and lower rates internationally raise questions regarding the appropriateness of some of these surgeries.[5,6]

Several studies have compared surgical and nonoperative treatment of patients with herniated disk, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evidence-based conclusions regarding optimal treatment.[7-12] The Spine Patient Outcomes Research Trial (SPORT) was initiated in March 2000 to compare the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation, spinal stenosis, or degenerative spondylolisthesis.[13] The trial included both a randomized cohort and an observational cohort who declined to be randomized in favor of designating their own treatment but otherwise met all the other criteria for inclusion and who agreed to undergo follow-up according to the same protocol. This article reports intent-to-treat results through 2 years for the randomized cohort.

Methods

Study Design

SPORT was conducted at 13 multidisciplinary spine practices in 11 US states (California, Georgia, Illinois, Maine, Michigan, Missouri, Nebraska, New York, New Hampshire, Ohio, Pennsylvania). The human subjects committee of each participating institution approved a standardized protocol. All patients provided written informed consent. An independent data and safety monitoring board monitored the study at 6-month intervals.[13]

Patient Population

Patients were considered for inclusion if they were 18 years and older and diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms despite some nonoperative treatment for at least 6 weeks. The content of preenrollment nonoperative care was not prespecified in the protocol but included education/counseling (71%), physical therapy (67%), epidural injections (42%), chiropractic therapy (32%), anti-inflammatory medications (61%), and opioid analgesics (40%).

Specific inclusion criteria at enrollment were radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) and evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise�positive between 30� and 70� or positive femoral tension sign) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution). Additionally, all participants were surgical candidates who had undergone advanced vertebral imaging (97% magnetic resonance imaging, 3% computed tomography) showing disk herniation (protrusion, extrusion, or sequestered fragment)[14] at a level and side corresponding to the clinical symptoms. Patients with multiple herniations were included if only one of the herniations was considered symptomatic (ie, if only one was planned to be operated on).

Exclusion criteria included prior lumbar surgery, cauda equina syndrome, scoliosis greater than 15�, segmental instability (>10� angular motion or >4-mm translation), vertebral fractures, spine infection or tumor, inflammatory spondyloarthropathy, pregnancy, comorbid conditions contraindicating surgery, or inability/unwillingness to have surgery within 6 months.

Study Interventions

The surgery was a standard open diskectomy with examination of the involved nerve root.[15,16] The procedure agreed on by all participating centers was performed under general or local anesthesia, with patients in the prone or knee-chest position. Surgeons were encouraged to use loupe magnification or a microscope. Using a midline incision reflecting the paraspinous muscles, the interlaminar space was entered as described by Delamarter and McCullough.[15] In some cases the medial border of the superior facet was removed to provide a clear view of the involved nerve root. Using a small annular incision, the fragment of disk was removed as described by Spengler.[16] The canal was inspected and the foramen probed for residual disk or bony pathology. The nerve root was decompressed, leaving it freely mobile.

The nonoperative treatment group received �usual care,� with the study protocol recommending that the minimum nonsurgical treatment include at least active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. Other nonoperative treatments were listed, and physicians were encouraged to individualize treatment to the patient; all nonoperative treatments were tracked prospectively.[13,17]

Study Measures

The primary measures were the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) bodily pain and physical function scales[18-21] and the American Academy of Orthopaedic Surgeons MODEMS version of the Oswestry Disability Index (ODI).[22] As specified in the trial protocol, the primary outcomes were changes from baseline in these scales at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment.

Secondary measures included patient self-reported improvement, work status, and satisfaction with current symptoms and with care.[23] Symptom severity was measured by the Sciatica Bothersomeness Index (range, 0-24; higher scores represent worse symptoms).[24,25]

Recruitment, Enrollment, and Randomization

A research nurse at each site identified potential participants and verified eligibility. For recruitment and informed consent, evidence-based videotapes described the surgical and non-operative treatments and the expected benefits, risks, and uncertainties.[26,27] Participants were offered enrollment in either the randomized trial or a concurrent observational cohort, the results of which are reported in a companion article.

Enrollment began in March 2000 and ended in November 2004. Baseline variables were collected prior to randomization. Patients self-reported race and ethnicity using National Institutes of Health categories.

Computer-generated random treatment assignment based on permuted blocks (randomly generated blocks of 6, 8, 10, and 12)[28] within sites occurred immediately after enrollment via an automated system at each site, ensuring proper allocation concealment. Study measures were collected at baseline and at regularly scheduled follow-up visits. Short-term follow-up visits occurred at 6 weeks and 3 months. If surgery was delayed beyond 6 weeks, additional follow-up data were obtained 6 weeks and 3 months postoperatively. Longer-term follow-up visits occurred at 6 months, 1 year from enrollment, and annually thereafter.

Statistical Analyses

We originally determined a sample size of 250 patients in each treatment group to be sufficient (with a 2-sided significance level of .05 and 85% power) to detect a 10-point difference in the SF-36 bodily pain and physical functioning scales or a similar effect size in the ODI. This difference corresponded to patients’ reports of being �a little better� in the Maine Lumbar Spine Study (MLSS).[29] The sample size calculation allowed for up to 20% missing data but did not account for any specific levels of nonadherence.

The analyses for the primary and secondary outcomes used all available data for each period on an intent-to-treat basis. Predetermined end points for the study included results at each of 6 weeks, 3 months, 6 months, 1 year, and 2 years. To adjust for the possible effect of missing data on the study results, the analysis of mean changes for continuous outcomes was performed using maximum likelihood estimation for longitudinal mixed-effects models under �missing at random� assumptions and including a term for treatment center. Comparative analyses were performed using the single imputation methods of baseline value carried forward and last value carried forward, as well as a longitudinal mixed model controlling for covariates associated with missed visits.[30]

For binary secondary outcomes, longitudinal logistic regression models were fitted using generalized estimating equations[31] as implemented in the PROC GENMOD program of SAS version 9.1 (SAS Institute Inc, Cary, NC). Treatment effects were estimated as differences in the estimated proportions in the 2 treatment groups.

P<.05 (2-sided) was used to establish statistical significance. For the primary outcomes, 95% confidence intervals (CIs) for mean treatment effects were calculated at each designated time point. Global tests of the joint hypothesis of no treatment effect at any of the designated periods were performed using Wald tests[32] as implemented in SAS. These tests account for the intraindividual correlation due to repeated measurements over time.[32]

Nonadherence to randomly assigned treatment may mean that the intention-to-treat analysis underestimates the real benefit of the treatment.[33,34] As a preplanned sensitivity analysis, we also estimated an �as-treated� longitudinal analysis based on comparisons of those actually treated surgically and nonoperatively. Repeated measures of outcomes were used as the dependent variables, and treatment received was included as a time-varying covariate. Adjustments were made for the time of surgery with respect to the original enrollment date to approximate the designated follow-up times. Baseline variables that were individually found to predict missing data or treatment received at 1 year were included to adjust for possible confounding.

Results

SPORT achieved full enrollment, with 501 (25%) of 1991 eligible patients enrolled in the randomized trial. A total of 472 participants (94%) completed at least 1 follow-up visit and were included in the analysis. Data were available for between 86% and 73% of patients at each of the designated follow-up times (Figure 1).

Figure 1 Flow Diagram of the SPORT RCT of Disc Herniation

Figure 1: Flow Diagram of the SPORT Randomized Controlled Trial of Disk Herniation: Exclusion, Enrollment, Randomization, and Follow-up.

Patient Characteristics

Baseline patient characteristics are shown in Table 1. Overall, the study population had a mean age of 42 years, with majorities being male, white, employed, and having attended at least some college; 16% were receiving disability compensation. All patients had radicular leg pain, 97% in a classic dermatomal distribution. Most of the herniations were at L5-S1, posterolateral, and were extrusions by imaging criteria.[14] The 2 randomized groups were similar at baseline.

Nonoperative Treatments

A variety of nonoperative treatments were used during the study (Table 2). Most patients received education/counseling (93%) and anti-inflammatory medications (61%) (nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or oral steroids); 46% received opiates; more than 50% received injections (eg, epidural steroids); and 29% were prescribed activity restriction. Forty-four percent received active physical therapy during the trial; however, 67% had received it prior to enrollment.

Surgical Treatment and Complications

Table 3 gives the characteristics of surgical treatment and complications. The median surgical time was 75 minutes (interquartile range, 58-90), with a median blood loss of 49.5 mL (interquar-tile range, 25-75). Only 2% required transfusions. There were no perioperative deaths; 1 patient died from complications of childbirth 11 months after enrollment. The most common intraoperative complication was dural tear (4%). There were no postoperative complications in 95% of patients. Reoperation occurred in 4% of patients within 1 year of the initial surgery; more than 50% of the reoperations were for recurrent herniations at the same level.

Nonadherence

Nonadherence to treatment assignment affected both groups, ie, some patients in the surgery group chose to delay or decline surgery, and some in the nonoperative treatment group crossed over to receive surgery (Figure 1). The characteristics of crossover patients that were statistically different from patients who did not cross over are shown in Table 4. Those more likely to cross over to receive surgery tended to have lower incomes, worse baseline symptoms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enrollment than the other patients receiving nonoperative treatment. Those more likely to cross over to receive nonoperative care were older, had higher incomes, were more likely to have an upper lumbar disk herniation, less likely to have a positive straight leg�raising test result, had less pain, better physical function, less disability on the ODI, and were more likely to rate their symptoms as getting better at enrollment than the other surgery patients.

Missing Data

The rates of missing data were equivalent between the groups at each time point, with no evidence of differential dropout according to assigned treatment. Characteristics of patients with missed visits were very similar to those of the rest of the cohort except that patients with missing data were less likely to be married, more likely to be receiving disability compensation, more likely to smoke, more likely to display baseline motor weakness, and had lower baseline mental component summary scores on the SF-36.

Intent-to-Treat Analyses

Table 5 shows estimated mean changes from baseline and the treatment effects (differences in changes from baseline between treatment groups) for 3 months, 1 year, and 2 years. For each measure and at each point, the treatment effect favors surgery. The treatment effects for the primary outcomes were small and not statistically significant at any of the points. As shown in Figure 2, both treatment groups showed strong improvements at each of the designated follow-up times, with small advantages for surgery. However, for each primary outcome the combined global test for any difference at any period was not statistically significant. This test accounts for intraindividual correlations as described in the �Methods� section.

Figure 2: Mean Scores Over Time for SF-36 Bodily Pain and Physical Function Scales and Oswestry Disability Index.

Table 5: Treatment Effects for Primary and Secondary Outcomes Based on Intent-to-Treat Analyses*

For the secondary outcome of sciatica bothersomeness, Table 5 and Figure 3 show that there were greater improvements in the Sciatica Bothersomeness Index in the surgery group at all designated follow-up times: 3 months (treatment effect, ?2.1; 95% CI, ?3.4 to ?0.9), 1 year (treatment effect, ?1.6; 95% CI, ?2.9 to ?0.4), and 2 years (treatment effect, ?1.6; 95% CI, ?2.9 to ?0.3), with results of the global hypothesis test being statistically significant (P=.003). Patient satisfaction with symptoms and treatment showed small effects in favor of surgery while employment status showed small effects in favor of nonoperative care, but none of these changes was statistically significant. Self-rated progress showed a small statistically significant advantage for surgery (P=.04).

Figure 3: Measures Over Time for Sciatica Bothersomeness Index, Employment Status, Satisfaction With Symptoms, Satisfaction With Care, and Self-rated Improvement.

As-treated analyses based on treatment received were performed with adjustments for the time of surgery and factors affecting treatment crossover and missing data. These yielded far different results than the intent-to-treat analysis, with strong, statistically significant advantages seen for surgery at all follow-up times through 2 years. For example, at 1 year the estimated treatment effects for the SF-36 bodily pain and physical function scales, the ODI, and the sciatica measures were 15.0 (95% CI, 10.9 to 19.2), 17.5 (95% CI, 13.6 to 21.5), ?15.0 (95% CI, ?18.3 to ?11.7), and ?3.2 (95% CI, ?4.3 to ?2.1), respectively.

Sensitivity analysis was performed for 4 different analytic methods of dealing with the missing data. One method was based on simple mean changes for all patients with data at a given time point with no special adjustment for missing data. Two methods used single imputation methods�baseline value carried forward and last value carried forward.[32] The latter method used the same mixed-models approach for estimating mean changes as given in Table 5 but also adjusted for factors affecting the likelihood of missing data. Treatment effect estimates at 1 year ranged from 1.6 to 2.9 for the SF-36 bodily pain scale, 0.74 to 1.4 for the physical function scale, ?2.2 to ?3.3 for the ODI, and ?1.1 to ?1.6 for the sciatica measures. Given these ranges, there appear to be no substantial differences between any of these methods.

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Dr. Alex Jimenez’s Insight

Herniated disc symptoms vary on the location of the condition and on the surrounding soft tissues affected along the spine. Lumbar disc herniations, one of the most common area for herniated discs to occur, are characterized by the compression of the nerve roots along the lower back and can generally cause symptoms of sciatica. Surgery is commonly recommended to treat disc herniations, however, numerous treatment methods can help manage the condition without the need of surgical interventions. A research study conducted on sciatica caused by herniated discs determined that about 73 percent of participants experienced an improvement in symptoms with nonoperative treatment. The results of this article concluded that nonoperative treatment can be as effective as surgery in the treatment of herniated discs.

Comment

Both operated and nonoperated patients with intervertebral disk herniation improved substantially over a 2-year period. The intent-to-treat analysis in this trial showed no statistically significant treatment effects for the primary outcomes; the secondary measures of sciatica severity and self-reported progress did show statistically significant advantages for surgery. These results must be viewed in the context of the substantial rates of nonadherence to assigned treatment. The pattern of nonadherence is striking because, unlike many surgical studies, both the surgical and nonoperative treatment groups were affected.[35] The most comparable previous trial[8] had 26% crossover into surgery at 1 year, but only 2% crossover out of surgery. The mixing of treatments due to crossover can be expected to create a bias toward the null.[34] The large effects seen in the as-treated analysis and the characteristics of the crossover patients suggest that the intent-to-treat analysis underestimates the true effect of surgery.

SPORT findings are consistent with clinical experience in that relief of leg pain was the most striking and consistent improvement with surgery. Importantly, all patients in this trial had leg pain with physical examination and imaging findings that confirmed a disk herniation. There was little evidence of harm from either treatment. No patients in either group developed cauda equina syndrome; 95% of surgical patients had no intraoperative complications. The most common complication, dural tear, occurred in 4% of patients, similar to the 2% to 7% noted in the meta-analysis by Hoffman et al,7 2.2% seen in the MLSS,[29] and 4% in the recent series from Stanford.[36]

One limitation is the potential lack of representativeness of patients agreeing to be randomized to surgery or nonoperative care; however, the characteristics of patients agreeing to participate in SPORT were very similar to those in other studies.[29,36] The mean age of 42 years was similar to the mean ages in the MLSS,[29] the series of Spangfort,[37] and the randomized trial by Weber,[8] and only slightly older than those in the recent series from Stanford (37.5 years).[36] The proportion of patients receiving workers’ compensation in SPORT (16%) was similar to the proportion in the Stanford population (19%) but lower than that in the MLSS population (35%), which specifically oversampled patients receiving compensation. Baseline functional status was also similar, with a mean baseline ODI of 46.9 in SPORT vs 47.2 in the Stanford series, and a mean baseline SF-36 physical function score of 39 in SPORT vs 37 in the MLSS.

The strict eligibility criteria, however, may limit the generalizability of these results. Patients unable to tolerate symptoms for 6 weeks and demanding earlier surgical intervention were not included, nor were patients without clear signs and symptoms of radiculopathy with confirmatory imaging. We can draw no conclusions regarding the efficacy of surgery in these other groups. However, our entry criteria followed published guidelines for patient selection for elective diskectomy, and our results should apply to the majority of patients facing a surgical decision.[38,39]

To fully understand the treatment effect of surgery compared with nonoperative treatment, it is worth noting how each group fared. The improvements with surgery in SPORT were similar to those of prior series at 1 year: for the ODI, 31 points vs 34 points in the Stanford series; for the bodily pain scale, 40 points vs 44 in the MLSS; and for sciatica bothersomeness, 10 points vs 11 in the MLSS. Similarly, Weber[8] reported 66% �good� results in the surgery group, compared with the 76% reporting �major improvement� and 65% satisfied with their symptoms in SPORT.

The observed improvements with nonoperative treatment in SPORT were greater than those in the MLSS, resulting in the small estimated treatment effect. The nonoperative improvement of 37, 35, and 9 points in bodily pain, physical function, and sciatica bothersomeness, respectively, were much greater than the improvements of 20, 18, and 3 points reported in the MLSS. The greater improvement with nonoperative treatment in SPORT may be related to the large proportion of patients (43%) who underwent surgery in this group.

The major limitation of SPORT is the degree of nonadherence with randomized treatment. Given this degree of crossover, it is unlikely that the intent-to-treat analysis can form the basis of a valid estimate of the true treatment effect of surgery. The �as-treated� analysis with adjustments for possible confounders showed much larger effects in favor of surgical treatment. However, this approach does not have the strong protection against confounding that is afforded by randomization. We cannot exclude the possibility that baseline differences between the as-treated groups, or the selective choice of some but not other patients to cross over into surgery, may have affected these results, even after controlling for important covariates. Due to practical and ethical constraints, this study was not masked through the use of sham procedures. Therefore, any improvements seen with surgery may include some degree of �placebo effect.�

Another potential limitation is that the choice of nonoperative treatments was at the discretion of the treating physician and patient. However, given the limited evidence regarding efficacy for most nonoperative treatments for lumbar disk herniation and individual variability in response, creating a limited, fixed protocol for nonoperative treatment was neither clinically feasible nor generalizable. The nonoperative treatments used were consistent with published guidelines.[17,38,39] Compared with the MLSS, SPORT had lower use of activity restriction, spinal manipulation, transcutaneous electrical nerve stimulation, and braces and corsets, and higher rates of epidural steroid injections and use of narcotic analgesics. This flexible nonoperative protocol had the advantages of individualization that considered patient preferences in the choice of nonoperative treatment and of reflecting current practice among multidisciplinary spine practices. However, we cannot make any conclusion regarding the effect of surgery vs any specific nonoperative treatment. Similarly, we cannot adequately assess the relative efficacy of any differences in surgical technique.

Conclusion

Patients in both the surgery and nonoperative treatment groups improved substantially over the first 2 years. Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small and not statistically significant except for the secondary measures of sciatica severity and self-rated improvement. Because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis alone.

Acknowledgments & Footnotes

Ncbi.nlm.nih.gov/pmc/articles/PMC2553805/

Manipulation or Microdiskectomy for Sciatica? A Prospective Randomized Clinical Study

Abstract

Objective: The purpose of this study was to compare the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disk herniation (LDH).

Methods: One hundred twenty patients presenting through elective referral by primary care physicians to neurosurgical spine surgeons were consecutively screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3-4, L4-5, or L5-S1. Forty consecutive consenting patients who met inclusion criteria (patients must have failed at least 3 months of nonoperative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture) were randomized to either surgical microdiskectomy or standardized chiropractic spinal manipulation. Crossover to the alternate treatment was allowed after 3 months.

Results: Significant improvement in both treatment groups compared to baseline scores over time was observed in all outcome measures. After 1 year, follow-up intent-to-treat analysis did not reveal a difference in outcome based on the original treatment received. However, 3 patients crossed over from surgery to spinal manipulation and failed to gain further improvement. Eight patients crossed from spinal manipulation to surgery and improved to the same degree as their primary surgical counterparts.

Conclusions: Sixty percent of patients with sciatica who had failed other medical management benefited from spinal manipulation to the same degree as if they underwent surgical intervention. Of 40% left unsatisfied, subsequent surgical intervention confers excellent outcome. Patients with symptomatic LDH failing medical management should consider spinal manipulation followed by surgery if warranted.

In conclusion, a herniated disc causes the soft, central portion of an intervertebral disc to bulge out a tear in its outer, fibrous ring as a result of degeneration, trauma, lifting injuries or straining. Most disc herniations can heal on their own but those considered to be severe may require surgical interventions to treat them. Research studies, such as the one above, have demonstrated that nonoperative treatment may help the recovery of a herniated disc without the need for surgery. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

Rapid Pain Relief for Herniated Discs in El Paso, TX

by spinedoctors | Cohort Studies, Conditions Treated, Herniated Disc, Physical Rehabilitation, Research Studies, Spinal Decompression Treatments, Treatments

Herniated discs are a debilitating condition characterized by pain, numbness and weakness in one or more limbs. While some people may experience no pain at all, those that do may often wish for fast pain relief to avoid long periods of sick leave from their jobs. Many healthcare professionals recommend surgery for patients with persistent and/or worsening herniated disc symptoms but other non-operative treatment options can help treat disc herniations. The purpose of the following article is to demonstrate how a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery.

A Structured Physiotherapy Treatment Model Can Provide Rapid Relief to Patients Who Qualify for Lumbar Disc Surgery: A Prospective Cohort Study

Abstract

Objective: To evaluate a structured physiotherapy treatment model in patients who qualify for lumbar disc surgery.
Design: A prospective cohort study.
Patients: Forty-one patients with lumbar disc herniation, diagnosed by clinical assessments and magnetic resonance imaging.
Methods: Patients followed a structured physiotherapy treatment model, including Mechanical Diagnosis and Therapy (MDT), together with graded trunk stabilization training. Study outcome measures were the Oswestry Disability Index, a visual analogue scale for leg and back pain, the Tampa Scale for Kinesiophobia, the European Quality of Life in 5 Dimensions Questionnaires, the Zung Self-Rating Depression Scale, the Self-Efficacy Scale, work status, and patient satisfaction with treatment. Questionnaires were distributed before treatment and at 3-, 12- and 24-month follow-ups.
Results: The patients had already improved significantly (p<0.001) 3 months after the structured physiotherapy treatment model in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvement could still be seen at the 2-year follow-up.
Conclusion: This study recommends adopting the structured physiotherapy treatment model before considering surgery for patients with symptoms such as pain and disability due to lumbar disc herniation.
Keywords: intervertebral disc displacement; rehabilitation; physical therapy modalities.

Introduction

Symptoms of lumbar disc herniation are relatively common in the general population, although the prevalence rates vary widely between different studies (1). Symptom severity also varies and, in many patients, pain and loss of function may lead to disability and long periods of sick leave (2). Spontaneous resolution of symptoms after a lumbar disc herniation is regarded as common, which makes it difficult to evaluate the effects of treatment. Furthermore, in studies evaluating spontaneous healing, different physiotherapy treatments are often included, together with pain medication (3�5), which makes it difficult to determine the extent of natural healing. On the other hand, in patients with sciatica, but without confirmed disc herniation on magnetic resonance imaging (MRI), approximately one-third of subjects recover 2 weeks after the onset of sciatica and approximately three-quarters recover after 3 months (6).

In contrast to evaluating spontaneous healing, surgery for lumbar disc herniation has been investigated in numerous studies. Surgery has been compared with a variety of treatments, such as education, chiropractic, unspecified physiotherapy, acupuncture, injections and medication (7�10). The non-surgical treatments have, however, been described only in vague terms, and variations in treatments have been used. Previous studies have reported favourable short-term (after 1 year) outcomes for surgery, but no major differences between surgical and other treatments have been demonstrated in the long term (over 2 years) (7, 10, 11). The conclusions that are drawn from the comparison between surgery and non-systematic non-surgical treatments may thus be misleading. This has been confirmed in a systematic review, which concluded that there is conflicting evidence as to whether surgery is more beneficial than nonsurgical care for both short- and long-term follow-up (12).

Kinesiophobia has been evaluated in patients after lumbar disc surgery, and almost 50% of patients were classified as having kinesiophobia (13). To our knowledge kinesiophobia has not been evaluated in patients with lumbar disc herniation treated with a structured physiotherapy treatment.

There are many different non-surgical treatment methods for patients with low-back pain and sciatica. One common management method is Mechanical Diagnosis and Therapy (MDT), also known as the McKenzie method, which aims to eliminate or minimize pain (14). A systematic review from 2004 of the efficacy of MDT showed that patients with low-back pain treated�with MDT reported a greater, more rapid reduction in pain and disability compared with non-steroidal anti-inflammatory drugs (NSAIDs), educational booklets, back massage and back care advice, strength training, spinal mobilization and general exercises (15). In a randomized controlled trial with a 1-year follow-up from 2008, Paatelma and co-workers (16) found that the McKenzie method was only marginally more effective compared with only giving advice to patients with low-back pain. For patients with low-back pain, sciatica and a verified lumbar disc herniation, it has, however, been shown that a selected group of patients who responded to MDT after 5 days of treatment also reported that they were satisfied after 55 weeks (17). The patients started treatment just 12 days after the onset of symptoms and the effects of spontaneous healing cannot therefore be excluded. Taken together, the treatment effects of MDT for patients with a verified lumbar disc herniation appear to require further evaluation.

Trunk stabilization exercises, which aim to restore deep trunk muscle control, have been used for the prevention and rehabilitation of low-back pain (18). A randomized controlled trial revealed a reduction in the recurrence of low-back pain episodes after specific trunk stabilization exercises compared with a control group receiving advice and the use of medication (19). Dynamic lumbar stabilization exercises have been found to relieve pain and improve function in patients who have undergone microdiscectomy (20). The effects of trunk stabilization exercises combined with MDT have, however, not been studied in patients with non-operated lumbar disc herniation. MDT is seldom recommended for patients with MRI verified lumbar disc herniation with a broken outer annulus. At our hospital, however, we have several years of good clinical experience of a combination of MDT and trunk stabilization exercises for this category of patients. To our knowledge, no previous study has investigated whether patients with a lumbar disc herniation verified by MRI, symptoms for at least 6 weeks (minimizing effects of spontaneous healing) and who qualified for disc surgery could improve with a structured physiotherapy treatment model including MDT and gradually progressive trunk stabilization exercises. The aim of this study was therefore to�evaluate a structured physiotherapy treatment model in patients who qualified for lumbar disc surgery.

Material and Methods

During the study inclusion period, 150 patients, who were referred to the orthopaedic clinic at Sahlgrenska University Hospital, Gothenburg, from November 2003 to January 2008, were identified as potential participants since disc herniation was confirmed with MRI. Inclusion criteria were: 18�65 years of age; MRI confirming disc herniation explaining the clinical findings; symptoms for at least 6 weeks (minimizing the effects of spontaneous healing) and pain distribution with concomitant neurological disturbances correlated to the affected nerve root. Exclusion criteria were: cauda equina syndrome, previous spinal surgery, other spinal diseases, such as spinal stenosis and spondylolisthesis, and inadequate command of Swedish. However, 70 patients were excluded because of spontaneous resolution of pain and symptoms. The remaining 80 patients met the inclusion criteria and qualified for surgery. Orthopaedic surgeons determined whether the patients qualified for lumbar disc surgery after MRI and physical examination according to the recommendations of the American Academy of Orthopaedic Surgeons for patients with lumbar disc herniation (21).

Figure 1 Study Flowchart

Initially, the study was planned as a randomized controlled trial (RCT) between a structured physiotherapy treatment model and surgery, but the number of patients was not sufficient to obtain acceptable power. Eighteen of the 80 patients were initially randomized to physiotherapy, 17 patients were randomized to surgery and 45 patients did not agree to undergo randomization. Twenty-seven of the 45 patients who did not agree to randomization agreed to take part in the structured physiotherapy treatment and 18 patients agreed to undergo surgery. A decision was therefore made solely to present a cohort of 45 patients treated according to the structured physiotherapytreatment protocol (Fig. 1). Patients were given verbal and written information and informed consent was obtained. The study was approved by the Regional Ethical Review Board.

Before structured physiotherapy treatment began, 4 patients recovered to the extent that they could no longer be accepted as surgical candidates and they were therefore excluded from the study. The remaining 41 patients treated according to the structured physiotherapy model are presented in this paper.

A Structured Physiotherapy Treatment Model

Six physiotherapists with credentialed examinations in MDT, which is an examination within the MDT concept after completing 4 courses of 4 days each for evaluating and treating patients with spinal problems. Following completion of these courses, an extensive literature study and practice in evaluating and treating patients is required before the examination can be completed. The physiotherapists involved in the study had 5�20 years of clinical experience of treating patients with back problems and herniated lumbar disc. The inter-examiner reliability of the MDT assessment has been shown to be good if the examiner is trained in the MDT method (22). The physiotherapists examined and treated the patients during a 9-week period (Table I). For the first 2 weeks of treatment, an MDT protocol was followed, based on clinical examinations of individual mechanical and symptomatic responses to positions and movements, with the aim of minimizing pain and with the emphasis on self-management (14). During the third week of treatment, graded trunk stabilization exercises were added to the MDT protocol. The purpose of graded trunk stabilization exercises was to improve muscle control (23). The low-load muscular endurance exercises were gradually increased in intensity on an individual�basis with respect to the patients� reported leg pain and the observed movement control and quality. During treatment, the patients were encouraged to continue exercising on their own at a gym, or to perform some other type of physical training of their own choice after the structured physiotherapy treatment was concluded. Four weeks after the completion of the 9-week physiotherapy treatment period, the patients attended a follow-up visit with the physiotherapist who had treated them. The aim of this visit was to encourage a high level of compliance with respect to continued trunk stabilization exercises and MDT practice (Table I).

Table 1 Treatment Procedures

Study Outcome Measures

The patients were given a battery of questionnaires to complete. Independent examiners, who were not involved in the treatment, distributed the questionnaires before treatment (baseline) and at the 3-, 12- and 24-month follow-ups.

The primary outcome measures were pain intensity in the leg, rated using a visual analogue scale (VAS) 0�100 mm (24) and the Oswestry Disability Index (ODI) 0�100 % (25). A score of 0�10 mm on the VAS was defined as no pain according to �berg et al. (26). An ODI score of 0�20% was defined as minimal or no disability, and a score of over 40% was defined as severe disability (25). These primary outcome measures are commonly used in evaluations after surgery for lowback pain and for assessing patients with lumbar disc herniation (27).

Secondary outcome measures included pain intensity in the back rated using a VAS and the degree of kinesiophobia using the Tampa Scale for Kinesiophobia (TSK). The TSK score varies between 17 and 68 and a cut-off more than 37 was defined as a high degree of kinesiophobia (28). Health-Related Quality of Life (HRQoL) in the European Quality of Life in 5 Dimensions Questionnaires (EQ-5D) was used. The EQ-5D includes 2 parts, EQ-5Dindex ranges from 0 to 1.0, where 1.0 is optimal health and EQ-5DVAS is a vertical visual analogue scale ranging from 0 (worst possible health state) to 100 (best possible health state) (29). The Zung Self-Rating Depression Scale (ZDS) ranges from 20�80 and the more depressed the patient is, the higher score (30). The Self-Efficacy Scale (SES) ranges from 8 to 64, with higher scores indicating more positive beliefs (31) was also used. Work status was measured using a 3-grade Likert scale: working full time, full-time sick leave and part-time sick leave. Likewise, patient�satisfaction with treatment was measured on a 3-grade Likert scale; satisfied, less satisfied and dissatisfied (32). These secondary outcome measures evaluate bio-psychosocial factors described as important in connection with lumbar disc surgery (33).

Table 2 Baseline Characteristics for the 41 Patients

Statistical Analyses

The results are presented as median values and interquartile range (IQR), except for age, which is presented as the mean and standard deviation (SD). Changes over time within the group were analysed with the Wilcoxon signed-rank test. Statistical significance was set at an alpha level of 0.05.

Results

The baseline characteristics are shown in Table II. No patient had undergone surgery at the 3-month follow-up. At the 12-month follow-up, 3 patients had undergone surgery and, at the 24-month follow-up, 1 additional patient had been operated on. After surgery, these 4 patients were excluded from further follow-ups (Fig. 1).

Change Over Time in Primary Outcome Measures

Disability. The patients showed significant improvements (p < 0.001) in ODI at the 3-month follow-up compared with baseline. The median (IQR) score decreased from 42 (27�53) to 14 (8�33). This improvement could still be seen at 12 and 24 months (Table III and Fig. 2). At baseline, 22 patients reported�severe disability (54%) and 3 patients reported no disability. The degree of disability decreased at the 3-month follow-up, as only 9 patients (22%) reported severe disability and 26 (64%) reported no disability. At 12- and 24-month follow-ups only 2 patients (5%) reported severe disability. At 12-month followup 26 patients still reported no disability, and at 24-month follow-up 27 patients reported no disability.

Figure 2 Visual Analogue Scale Leg Pain and Oswestry Disability Index

Leg pain. A significant reduction in patients� leg pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. The median (IQR) on the VAS decreased from 60 (40�75) to 9 (2�27). This improvement could still be seen at the 12- and 24-month follow-ups (Table III and Fig. 2). Before treatment, all patients reported leg pain. Three months after treatment, the median on the VAS was 9 mm, i.e. classified as no leg pain (26). Twenty-three patients (56%) reported no leg pain at the 3-month follow-up. At the 12-month follow-up 22 patients reported no leg pain, and after 24 months 24 patients reported no leg pain.

Table 3 Changes Over Time in Primary and Secondary Outcome Measures

Change in Secondary Outcome Measures Over Time

Back pain. A significant improvement in back pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. This improvement could still be seen at 12 and 24 months (Table III). At baseline, 6 patients (15%) reported no back pain. Three months after treatment began, 20 patients (49%) reported no back pain.

Figure 3 Number of Patients Classified with Kinesiophobia at Baseline

Kinesiophobia. The degree of kinesiophobia showed a significant improvement at the 3-month follow-up (p < 0.001) and the improvement could be seen throughout the follow-up period (Table III). Before treatment, 25 patients (61%) were classified as having kinesiophobia and 15 patients (37%) had no kinesiophobia, while data for 1 patient was missing. After 3 months, 15 patients (37%) had kinesiophobia and 26 (63%) had no kinesiophobia. At the 12-month follow-up, the number of patients with kinesiophobia had reduced to 4 (11%) (Fig. 3).

Health-related quality of life, depression and self-efficacy. All 4 assessments (EQ-5Dindex, EQ-5DVAS, ZDS and SES) showed significant improvements at the 3-month follow-up (p < 0.001). This improvement could still be seen at 12 and 24 months (Table III).

Sick leave. At baseline, 22 patients (54%) were on full-time sick leave (Table IV), compared with 9 (22%) patients at�the 3-month follow-up. At baseline, 14 patients (34%) were working full time, compared with 22 (54%) at the 3-month follow-up.

Table 4 Number of Patients on Sick Leave at Each Follow Up

Satisfaction with Treatment

At the 3-month follow-up, 32 (78%) of 41 patients were satisfied with the structured physiotherapy treatment. Seven patients were less satisfied and 2 patients were dissatisfied. Both of the dissatisfied patients were later operated. At the 2-year follow-up, the number of satisfied patients was 29 (80%) of 36. Seven patients were less satisfied, but none dissatisfied after structured physiotherapy treatment.

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Dr. Alex Jimenez’s Insight

A disc herniation in the lumbar spine can cause pain, numbness and weakness in the lower back. Because of the severity of the symptoms, many patients seeking fast pain relief consider surgery. However, many non-operative treatment options can help improve as well as manage lumbar herniated disc symptoms.�A structured physiotherapy treatment model can provide rapid pain relief to patients who would otherwise qualify for lumbar disc surgery, according to the following article. Patients looking to avoid taking long periods of sick leave from work due to their symptoms may benefit from a structured physiotherapy treatment model. As with any type of injury and/or condition, the use of other treatment options should be properly considered before turning to surgical interventions for fast pain relief.

Discussion

The principal finding of this study was that patients who qualified for lumbar disc surgery improved to a statistically significant and clinically substantial degree just 3 months after the start of the structured physiotherapy treatment in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvements could still be seen at the 2-year follow-up.

The natural course of healing must be considered carefully, especially when evaluating treatment effects in patients with disc herniation. The symptoms often vary over time and many discs heal spontaneously and the symptoms cease. Approximately 75% of patients with sciatica, without an MRI-verified disc herniation, recover within 3 months, and approximately one-third of patients recover within 2 weeks after the onset of sciatica (6). The natural course of sciatica was evaluated in a randomized controlled trial (34), which compared NSAIDs with placebo. The patients were, however, examined within 14 days after the onset of radiating leg pain. After 3 months, 60% of the patients had recovered and, after 12 months, 70% had recovered. In order to minimize the influence of spontaneous healing in the present study, the patients were therefore included only if they had had persistent pain and disability for more than 6 weeks. In fact, the majority of the patients had had pain and disability for more than 3 months. It is therefore most likely that the effects of treatment seen in the present study are, in the majority of patients, an effect of the structured physiotherapy treatment model and not a result of spontaneous healing.

In the study by Weber et al. (34), the VAS leg pain mean score was reduced from 54 mm at baseline to 19 mm within 4 weeks for all 183 patients, regardless of treatment. After 1 year, the VAS leg pain mean score was 17 mm. The patients in the present study who were a little worse at baseline (60 mm) reported 9 mm on the VAS leg pain just 3 months after treatment. Consequently, in the present study, the median VAS level had already been reduced to under the no-pain score, defined as 0�10 on the VAS (26), at the 3-month follow-up and this was maintained to the 12- and 24-month follow-ups.

Physiotherapy treatment for patients with lumbar disc herniation can lead to improvements. Br�tz et al. (17) included a selected group of patients who responded with the centralization of pain after the first 5 daily sessions of treatment according to the MDT method. Centralization of pain is defined as a clinically induced change in the location of pain referred from the spine, that moves from the most distal position toward the lumbar midline (35). However, the patients� medium duration of symptoms before treatment was only 12 days and the possibility that patients recovered naturally cannot therefore be excluded (17).

In a retrospective study, 95 patients were treated with a functional restoration programme (36). The patients achieved significant improvements after a mean treatment period of 8.7 months. The evaluation was performed at discharge only. With a treatment period of this length, it is, however, difficult to differentiate between the effects of treatment and the natural healing process. In the present study, a shorter treatment period was adopted, and large and significant improvements were found after just 3 months and were still present at the 24-month follow-up. It is therefore not likely that the natural healing process was responsible for the positive results in the present study.

In a prospective study of 82 consecutive patients with acute severe sciatica, included for conservative management, only a minority of the patients had made a full recovery after 12 months (37). Twenty-five percent of the patients underwent surgery within 4 months and one-third had surgery within 1 year. In spite of the fact that the inclusion criteria in the present study followed the recommendations for surgery (21, 38), no patient required surgery at the 3-month follow-up and, after 12 months, only 3 patients (7%) had undergone surgery. The interpretation of the divergence could be that the structured physiotherapy treatment model used in the present study appeared to influence patients with lumbar disc herniation in a very positive direction. One recommendation is therefore to follow the structured physiotherapy treatment model before considering surgery.

In this study, MRI verification of disc herniation was an inclusion criterion. In clinical practice, MRI verification is not mandatory, as it is in surgical treatment, before introducing structured physiotherapy treatment to patients with symptoms from a disc herniation. Consequently, treatment according to the structured physiotherapy treatment model can start early after the commencement of symptoms, as it is not necessary to wait for an MRI. It is possible to speculate that, if treatment with a structured physiotherapy model starts earlier than in the present study, the improvements would be even better, further reducing the risk of persistent pain and accompanying problems. Moreover, the need for MRI is likely to diminish; this, however, should be further evaluated in future studies.

One explanation for the good results of this study could be that the patients followed a structured physiotherapy treatment model, comprising MDT and trunk stabilization exercises, allowing for an individual design and progression of the treatment. Similar results were described in a retrospective cohort study (39) using several treatment methods for pain control as well as for exercise training for patients with lumbar disc herniation. The evaluation was not carried out until approximately 31 months after treatment. The results of Saal et al. (39) and of the present study are in agreement, in that structured physiotherapy treatment can reduce symptoms, but symptoms were relieved much more rapidly in the present study.

In a multicentre study comprising 501 patients, randomized to surgery or non-operative care, 18% of the patients assigned to non-operative treatment underwent surgery within 6 weeks and 30% had surgery at approximately 3 months (7). The nonoperative treatment group received non-specified �usual care�, which could include a variety of different treatment methods. In contrast, the patients in the present study were offered a structured physiotherapy treatment model that included both bio-psychological and social components, as described in the International Classification of Functioning, Disability and Health (40).

There are many possible explanations for the positive effects seen in this present study, and 5 of these will now be discussed. Firstly, the patients were well informed about the design of the structured physiotherapy treatment model, including the timetable for different phases of the treatment and when the treatment was planned to end. This information enhanced the patients� opportunity for self-management and gave them an active role in treatment decision-making.

Secondly, the patients acquired strategies to deal with their pain by using the different activities and movements in order to reduce pain according to the MDT method (14). The MDT method aims to enhance the patients� ability to cope with the symptoms, motivate the patient to comply with the treatment and empower them to achieve independence. Leijon et al. (41) have shown that low levels of motivation plus pain are important factors that enhance non-adherence to physical activity. It therefore appears important to reduce pain and increase motivation as early as possible. It is reasonable to believe that, when the patients participated in the evaluation of different activities and exercises, this augmented their opportunity to discover the connection between activities and the following reduction or increase in symptoms. This could have led to the increased self-efficacy and empowerment of the patients. The use of empowerment in physiotherapy has been recommended in a review by Perrault (42), who argues that empowerment improves the intervention.

Thirdly, the intensity of exercises was gradually increased on an individual basis with respect to the patients� reported pain. The objective was to strengthen the patients� self-efficacy, which also improved significantly in the present study. Fourthly, the trunk stabilization exercises were conducted with the aim of increasing deep trunk muscle control (23). It can be speculated that the physiological effects of training may also have led to reduced pain through increased blood circulation, muscle relaxation and the release of pain-reducing substances, such as endorphins.

Finally, one reason for the improvements could be that the physiotherapists were experienced and well educated in the MDT method. Subsequently, the physiotherapists were able to guide the patients during the rehabilitation process. It is, however, not possible to determine whether and how much each of the reasons discussed above contributed to the improvements. It seems reasonable to assume that all 5 factors were operating.

In this study, the majority of patients experienced kinesiophobia before treatment started. As early as 3 months after the structured physiotherapy treatment started, the number of patients with kinesiophobia fell dramatically and the majority of patients no longer experienced kinesiophobia. These results are in agreement with those of a study of patients with chronic pain and high kinesiophobia who increased their physical activity level after a pain management programme designed to enable the patients to regain overall function (43).

There are some limitations to this study. It is not possible to exclude the possibility that some patients may have improved spontaneously without treatment. Measures were taken to limit this risk by using symptoms for at least 6 weeks as an inclusion criterion. Again, the majority of patients had symptoms for more than 3 months. Another limitation might relate to whether the patients were selected accurately for the study. Clinically experienced orthopaedic surgeons evaluated the clinical findings and the MRI scans and classified the patients as surgical candidates based on recommendations from the American Academy of Orthopaedic Surgeons for intervention for disc herniation published in 1993 (21). The patients included in the present study also fulfilled the recommendations as presented by Bono and co-workers in 2006 (38). The patients can therefore be regarded as serving as their own controls, and comparisons can be made with baseline symptoms and with patients from other studies. An RCT would have been the best way to explore different treatment options; however, we did not reach the number of patients required for an RCT. As the treatment model used in the present study has not been evaluated previously in a group of patients with long-standing pain, with the majority of the patients having pain for more than 3 months due to disc herniation, and, as the results are clinically interesting, it was decided to present the results as a cohort study.

In conclusion, this study shows that patients eligible for lumbar disc surgery improved significantly after treatment with the structured physiotherapy model, as early as 3 months after treatment, and the results could still be seen at the 24-month follow-up. Consequently, these patients did not qualify for lumbar disc surgery 3 months after the physiotherapy treatment started. Moreover, the majority of patients had symptoms for more than 3 months at the start of treatment and, for this reason, most of the spontaneous healing ought to have occurred before this study started. This study therefore recommends adoption of the structured physiotherapy treatment model before considering surgery when patients report symptoms such as pain and disability due to lumbar disc herniation.

Acknowledgements

The authors would like to thank physiotherapists Patrik Drevander, Christina Grund�n, Sofia Frid�n and Eva Fahlgren for treating the patients and Valter Sundh for statistical support. This study was supported by grants from the Health & Medical Care Committee of the V�stra G�taland Region, Ren�e Eander�s Foundation and Wilhelm & Martina Lundgren�s Foundation of Science.

Herniated discs can cause pain, numbness and weakness, a variety of symptoms which may often become so severe, that surgery might seem like the only option for fast relief. However, a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery, according to the results of the research study. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Neck Pain

Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

Constipation And Sciatica Treatment In El Paso, TX.

by Dr Alex Jimenez | Conditions Treated, Gastro Intestinal Health, Sciatica, Sciatica Nerve Pain

Constipation & Sciatica:

Constipation is an uncomfortable and common side effect of lower back and leg pain conditions. Sciatic nerve pain can occur at the same time as constipation does, but can also alternate where constipation ensues followed by sciatica.

Finding lasting relief is crucial, but understanding the exact reasons why the symptoms occur is just as important. These two conditions can be related or they may be completely coincidental. But the more they occur together, or in succession, there is greater chance that some structural or body connection is happening between the two.

The Facts: Sciatica & Constipation

Investigate why the source process may be the same for both conditions in some.

Constipation,�known as a recurrent and chronic health concern which plagues some people their entire lives. It can be caused by a variety of anatomical reasons, but many of these are fairly easy to diagnose, despite being difficult to cure using traditional medical therapy.

Sciatica is very much the same in that it can be chronic, recurrent and sometimes treatment-resistant.

What these disorders have in common is that they are often linked by nerve compression conditions within the spine. The source can be central or foraminal stenosis, which leads to compression of one or more of the lumbar nerve roots.

It is also possible for cervical central spinal stenosis to cause sciatica and may contribute to constipation, as well.

Both conditions are associated with the mind and body processes, that is physical illness caused or aggravated by mental factors, i.e. stress or some type of conflict. Constipation can be linked to conscious and subconscious emotional issues, while sciatica is just starting to receive the same recognition as a possible mind and body disorder.

Constipation/Sciatica: Solutions

Sciatica cases where constipation is also present involves the nerve roots in the lower spinal regions. These types of symptomatic expressions will be blamed on a variety of structural abnormalities in the lumbosacral region, which include degenerative disc disease, herniated discs and spinal osteoarthritis.

An alternative explanation for many cases of constipation accompanied by sciatica is regional oxygen deprivation. The solution to this condition is the treatment option invented by Dr. John Sarno. This simple treatment can usually solve even the most harmful of sciatica concerns. But the therapy remains controversial as it helps some and not others.

Sciatica/Constipation: Analysis

Once the symptoms have been diagnosed, if symptoms are structural, then treatments should resolve them or at least help in controlling the pain. If various treatments have been utilized with no relief, then it could be misdiagnosis.

Another anatomical condition that could be responsible for the symptoms or the cause could be a combination of the aforementioned mind and body issues working together. An epidemic problem that the healthcare system and one of the underlying reasons why so many with back, neck and sciatica pain never find a lasting cure. Don’t be surprised if to find out the pain was inaccurately diagnosed. This happens to millions every day.

Constipation can also be a result of serious internal diseases or organ malfunctions. Request a complete workup, which includes appropriate diagnostic testing for any significant or chronic constipation case.

Sometimes, this combination of symptoms may indicate the first signs of cauda equina syndrome.�This is a medical emergency and must be treated immediately.

Many will disregard any notion that sciatica is caused by constipation. Constipation can cause sciatica check other websites. Doctors do agree that constipation is one of a many of causes of sciatica.

But the bowels and the lower back are different parts of the body. It is important to understand that all parts of the body are connected in some way or other.

Sciatica?

If there is pain in the lower back near the buttocks and that pain travels down one or both legs, then chances are sciatica is present. Sciatica has become a common lower back pain that doctors, chiropractors, acupuncturists and physical therapists treat frequently. The pain is characterized with a combination of dull and sharp aches that create a feeling of pins and needles. With nerve conditions pins and needles are the most common type of pain.

Sciatica is the result of sciatic nerve compression. Constipation is a non-spinal condition that can cause sciatica. Just trying to use the bathroom can cause pain by irritating the sciatic nerve.

Sciatica happens when the sciatic nerve, which is the largest in the body, is compressed by an external pressure. Women in child birth and men who carry their wallets in the back pocket can experience sciatica.

Sciatica is treatable; if experiencing constipation and lower back pain at the same time, ask a doctor to test for sciatica. Doctors will order a CT scan, MRI, X-Ray or nerve conduction test.

Solving The Problem:

Experiencing sciatica related to constipation, then the first course of action is diet change. A fiber-infused diet that combines fruits and vegetables can relieve constipation. Or consider a fiber supplement.

Pain Reduction:

While waiting for constipation relief, there are various ways to reduce pain.

Take aspirin or ibuprofen, Anti-inflammatory medications reduce nerve and muscle inflammation, which alleviate nerve irritation.
Alternate hot and cold compresses, which reduce inflammation and sooth the pain. Can also be applied to the legs if the pain travels down the body.
Consider a firm mattress to support the back and alleviate any sciatica that may be the result from back strain.
A doctor may recommend several days of rest in order to allow the nerve damage time to heal.

Rules To Remember:

Do not bend or sit in a soft chair. Back support is critical.
Do not ignore the pain. Nerve pain heals within a week or gets worse.
Move slowly when standing or getting in and out of bed.
No heavy lifting & sometimes no lifting at all.

Good Nutrition & Chiropractic Treatment Contribute To Overall Well-Being

Assessment and Treatment of the Infraspinatus

by spinedoctors | Chiropractic, Conditions Treated, Functional Medicine

These assessment and treatment recommendations represent a synthesis of information derived from personal clinical experience and from the numerous sources which are cited, or are based on the work of researchers, clinicians and therapists who are named (Basmajian 1974, Cailliet 1962, Dvorak & Dvorak 1984, Fryette 1954, Greenman 1989, 1996, Janda 1983, Lewit 1992, 1999, Mennell 1964, Rolf 1977, Williams 1965).

Clinical Application of Neuromuscular Techniques: Infraspinatus

Assessment of Shortness in the Infraspinatus

Infraspinatus shortness test (a) The patient is asked to reach upwards, backwards and across to touch the upper border of the opposite scapula, so producing external rotation of the humeral head. If this effort is painful infraspinatus shortness should be suspected.

Infraspinatus shortness test (b) (see Fig. 4.37 below) Visual evidence of shortness is obtained by having the patient supine, upper arm at right angles to the trunk, elbow flexed so that lower arm is parallel with the trunk, pointing caudad with the palm downwards. This brings the arm into internal rotation and places infraspinatus at stretch. The practitioner ensures that the shoulder remains in contact with the table during this assessment by means of light compression.

Figure 4.37 Assessment and self-treatment position for infraspinatus. If the upper arm cannot rest parallel to the floor, possible shortness of infraspinatus is indicated.�If infraspinatus is short, the lower arm will not be capable of resting parallel with the floor, obliging it to point somewhat towards the ceiling.

Assessment for Infraspinatus Weakness

The patient is seated. The practitioner stands behind. The patient�s arms are flexed at the elbows and held to the side, and the practitioner provides isometric resistance to external rotation of the lower arms (externally rotating them and also the humerus at the shoulder). If this effort is painful, an indication of probable infraspinatus shortening exists.

The relative strength is also judged. If weak, the method discussed by Norris (1999) should be used to increase strength (isotonic eccentric contraction performed slowly).

NOTE: In this as in other tests for weakness there may be a better degree of cooperation if the practitioner applies the force, and the patient is asked to resist as much as possible. Force should always be built slowly and not suddenly.

MET Treatment of Infraspinatus

Figure 4.38 MET treatment of infraspinatus. Note that the practitioner�s left hand maintains a downward pressure to stabilise the shoulder to the table during this procedure.

The patient is supine, upper arm at right angles to the trunk, elbow flexed so that lower arm is parallel with the trunk, pointing caudad with the palm downwards. This brings the arm into internal rotation and places infraspinatus at stretch.

The practitioner ensures that the posterior shoulder remains in contact with the table by means of light compression. The patient slowly and gently lifts the dorsum of the wrist towards the ceiling, against resistance from the practitioner, for 7�10 seconds.

After this isometric contraction, on relaxation, the forearm is taken towards the floor (combined patient and practitioner action), so increasing internal rotation at the shoulder and stretching infraspinatus (mainly at its shoulder attachment).

Care needs to be taken to prevent the shoulder from rising from the table as rotation is introduced, so giving a false appearance of stretch in the muscle. In order to initiate stretch of infraspinatus at the scapular attachment, the patient is seated with the arm (flexed at the elbow) fully internally rotated and taken into full adduction across the chest. The practitioner holds the upper arm and applies sustained traction from the shoulder in order to prevent subacromial impingement.

The patient is asked to use a light (20% of strength) effort to attempt to externally rotate and abduct the arm, against resistance offered by the practitioner, for 7�10 seconds.

After this isometric contraction, and with the traction from the shoulder maintained, the arm is taken into increased internal rotation and adduction (patient and practitioner acting together) where the stretch is held for at least 20 seconds.

Dr. Alex Jimenez offers an additional assessment and treatment of the hip flexors as a part of a referenced clinical application of neuromuscular techniques by Leon Chaitow and Judith Walker DeLany. The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

By Dr. Alex Jimenez

Additional Topics: Wellness

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

Chiropractic Spinal Manipulative Therapy for Migraine

by Dr Alex Jimenez | Chiropractic, Clinical Case Reports, Clinical Case Series, Conditions Treated, Functional Medicine, Migraine, Migraines, Physical Rehabilitation

Headaches can be a real aggravating issue, especially if these begin to occur more frequently. Even more so, headaches can become a bigger problem when the common type of head pain becomes a migraine. Head pain is often a symptom resulting from an underlying injury and/or condition along the cervical spine, or upper back and neck. Fortunately, a variety of treatment methods are available to help treat headaches. Chiropractic care is a well-known alternative treatment option which is commonly recommended for neck pain, headaches and migraines. The purpose of the following research study is to determine the effectiveness of chiropractic spinal manipulative therapy for migraine.

Chiropractic Spinal Manipulative Therapy for Migraine: a Study Protocol of a Single-Blinded Placebo-Controlled Randomised Clinical Trial

Abstract

Introduction

Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).

Method and Analysis

According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1?month run-in, 3?months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12?months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs.

Ethics and Dissemination

The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals.

Trial Registration Number

NCT01741714.

Keywords: Statistics & Research Methods

Strengths and Limitations of this Study

The study will be the first three-armed manual therapy randomised clinical trial (RCT) assessing the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continue usual pharmacological management without receiving manual intervention) for migraineurs.
Strong internal validity, since a single chiropractor will conduct all interventions.
The RCT has the potential to provide a non-pharmacological treatment option for migraineurs.
Risk for dropouts is increased due to strict exclusion criteria and 17?months duration of the RCT.
A generally accepted placebo has not been established for manual therapy; thus, there is a risk for unsuccessful blinding, while the investigator who provides the interventions cannot be blinded for obvious reasons.

Background

Migraine is a common health problem with substantial health and socioeconomic costs. On the recent Global Burden of Disease study, migraine was ranked as the third most common condition.[1]

Image of a woman with a migraine demonstrated by lightning coming out of her head.

About 15% of the general population have migraine.[2, 3] Migraine is usually unilateral with pulsating and moderate/severe headache which is aggravated by routine physical activity, and is accompanied by photophobia and phonophobia, nausea and sometimes vomiting.[4] Migraine exists in two major forms, migraine without aura and migraine with aura (below). Aura is reversible neurological disturbances of the vision, sensory and/or speech function, occurring prior to the headache. However, intraindividual variations from attack to attack are common.[5, 6] The origin of migraine is debated. The painful impulses may originate from the trigeminal nerve, central and/or peripheral mechanisms.[7, 8] Extracranial pain sensitive structures include the skin, muscles, arteries, periosteum and joints. The skin is sensitive to all usual forms of pain stimuli, while temporal and neck muscles may especially be sources for pain and tenderness in migraine.[9�11] Similarly, the frontal supraorbital, superficial temporal, posterior and occipital arteries are sensitive to pain.[9, 12]

Notes

The International Classification of Headache Disorders-II Diagnostic Criteria for Migraine

Migraine without Aura

A. At least five attacks fulfilling criteria B�D
B. Headache attacks lasting 4�72?h (untreated or unsuccessfully treated)
C. Headache has at least two of the following characteristics:
1. Unilateral location
2. Pulsating quality
3. Moderate or severe pain intensity
4. Aggravated by or causing avoidance of routine physical activity
D. During headache at least one of the following:
1. Nausea and/or vomiting
2. Photophobia and phonophobia
E. Not attributed to another disorder
Migraine with aura
A. At least two attacks fulfilling criteria B�D
B. Aura consisting of at least one of the following, but no motor weakness:
1. Fully reversible visual symptoms including positive features (ie, flickering lights, spots or lines) and/or negative features (ie, loss of vision). Moderate or severe pain intensity
2. Fully reversible sensory symptoms including positive features (ie, pins and needles) and/or negative features (ie, numbness)
3. Fully reversible dysphasic speech disturbance
C. At least two of the following:
1. Homonymous visual symptoms and/or unilateral sensory symptoms
2. At least one aura symptom develops gradually over ?5?min and/or different aura symptoms occur in succession over ?5?min
3. Each symptom lasts ?5 and ?60?min
D. Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows the aura within 60?min
E. Not attributed to another disorder

Pharmacological management is the first treatment option for migraineurs. However, some patients do not tolerate acute and/or prophylactic medicine due to side effects or contraindications due to comorbidity of other diseases or due to a wish to avoid medication for other reasons. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns. The prevalence of medication overuse headache (MOH) is 1�2% in the general population,[13�15] that is, about half the population suffering chronic headache (15 headache days or more per month) have MOH.[16] Migraine causes loss of 270 workdays per year per 1000 persons from the general population.[17] This corresponds to about 3700 work years lost per year in Norway due to migraine. The economic cost per migraineur was estimated to be $655 in USA and �579 in Europe per year.[18, 19] Owing to the high prevalence of migraine, the total cost per year was estimated to be $14.4 billion in the USA and �27 billion in the EU countries, Iceland, Norway and Switzerland at that time. Migraine costs more than neurological disorders such as dementia, multiple sclerosis, Parkinson’s disease and stroke.[20] Thus, non-pharmacological treatment options are warranted.

The Diversified technique and the Gonstead method are the two most commonly used chiropractic manipulative treatment modalities in the profession, used by 91% and 59%, respectively,[21, 22] along with other manual and non-manual interventions, that is, soft tissue techniques, spinal and peripheral mobilisation, rehabilitation, postural corrections and exercises as well as general nutrition and dietetic advice.

A few spinal manipulative therapy (SMT) randomised controlled trials (RCTs) using the Diversified technique have been conducted for migraine, suggesting an effect on migraine frequency, migraine duration, migraine intensity and medicine consumption.[23�26] However, common for previous RCTs are the methodological shortcomings such as inaccurate headache diagnosis, that is, questionnaire diagnoses used are imprecise,[27] inadequate or no randomisation procedure, lack of placebo group, and primary and secondary end points not prespecified.[28�31] In addition, previous RCTs did not consequently adhere to the recommended clinical guidelines from the International Headache Society (IHS).[32, 33] At present, no RCTs have applied the Gonstead chiropractic SMT (CSMT) method. Thus, considering the methodological shortcomings in previous RCTs, a clinical placebo-controlled RCT with improved methodological quality remains to be conducted for migraine.

The SMT mechanism of action on migraine is unknown. It is argued that migraine might originate from a complexity of nociceptive afferent responses involving the upper cervical spine (C1, C2 and C3), leading to a hypersensitivity state of the trigeminal pathway conveying sensory information for the face and much of the head.[34, 35] Research has thus suggested that SMT may stimulate neural inhibitory systems at different spinal cord levels, and might activate various central descending inhibitory pathways.[36�40] However, although the proposed physiological mechanisms are not fully understood, there are most likely additional unexplored mechanisms which could explain the effect SMT has on mechanical pain sensitisation.

Double image of a woman with a migraine and a diagram showcasing the human brain during a migraine.

The objective of this study is to assess the efficacy of CSMT versus placebo (sham manipulation) and controls (continue usual pharmacological management without receiving manual intervention) for migraineurs in an RCT.

Method and Design

This is a single-blinded placebo-controlled RCT with three parallel groups (CSMT, placebo and control). Our primary hypothesis is that CSMT gives at least 25% reduction in the average number of migraine days per month (30?days/month) as compared to placebo and control from baseline to the end of intervention, and we expect the same reduction to be maintained at 3, 6 and 12?months follow-up. If the CSMT treatment is effective, it will be offered to participants who received placebo or control after study completion, that is, after 12?months follow-up. The study will adhere to the recommended clinical trial guidelines from the IHS,32 33 and the methodological CONSORT and SPIRIT guidelines.[41, 42]

Patient Population

Participants will be recruited in the period January to September 2013 through the Akershus University Hospital, through general practitioners and media advertisement, that is, posters with general information will be put up at general practitioners� offices along with oral information in the Akershus and Oslo counties, Norway. Participants will receive posted information about the project followed by a short telephone interview. Those recruited from the general practitioners� offices will have to contact the clinical investigator whose contact details have been provided on the posters in order to obtain extensive information about the study.

Eligible participants are between 18 and 70?years of age and have at least one migraine attack per month. Participants are diagnosed according to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-II) by a neurologist at the Akershus University Hospital.[43] They are only allowed to have co-occurrence of tension-type headache and not other primary headaches.

Exclusion criteria are contraindication to SMT, spinal radiculopathy, pregnancy, depression and CSMT within the previous 12?months. Participants whom during the RCT receive any manual interventions by physiotherapists, chiropractors, osteopaths or other health professionals to treat musculoskeletal pain and disability, including massage therapy, joint mobilisation and manipulation,[44] changed their prophylactic headache medicine or pregnancy will be withdrawn from the study at that time and be regarded as dropouts. They are allowed to continue and change their usual acute migraine medication throughout the trial.

In response to initial contact, participants fulfilling the inclusion criteria will be invited to further assessment by the chiropractic investigator. The assessment includes an interview and a physical examination with special emphasis on the whole spinal column. Oral and written information about the project will be provided in advance and oral and written consent will be obtained from all accepted participants during the interview and by the clinical investigator. In accordance with good clinical practice, all patients will be informed about the harms and benefits as well as possible adverse reactions of the intervention primarily including local tenderness and tiredness on the treatment day. No serious adverse events have been reported for the chiropractic Gonstead method.[45, 46] Participants randomised into active or placebo interventions will undergo a full spine radiographic examination and be scheduled for 12 intervention sessions. The control group will not be exposed to this assessment.

Clinical RCT

The clinical RCT consists of a 1?month run-in and 3?months intervention. Time profile will be assessed from baseline to the end of follow-up for all end points (Figure 1).

Figure 1: Study flow chart. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

Run-In

The participants will fill in a validated diagnostic paper headache diary 1?month prior to intervention which will be used as baseline data for all participants.[47, 48] The validated diary includes questions directly related to the primary and secondary end points. X-rays will be taken in standing position in the anterioposterior and lateral planes of the entire spine. The X-rays will be assessed by the chiropractic investigator.

Randomisation

Prepared sealed lots with the three interventions, that is, active treatment, placebo and the control group, will be subdivided into four subgroups by age and gender, that is, 18�39 and 40�70?years of age and men and women, respectively. Participants will be equally allocated to the three groups by allowing the participant to draw one lot only. The block randomisation will be administrated by an external trained party with no involvement from the clinical investigator.

Intervention

Active treatment consists of CSMT using the Gonstead method,[21] that is, a specific contact, high-velocity, low-amplitude, short-lever spinal with no postadjustment recoil directed to spinal biomechanical dysfunction (full spine approach) as diagnosed by standard chiropractic tests.

The placebo intervention consists of sham manipulation, that is, a broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-intentional and non-therapeutic directional line. All the non-therapeutic contacts will be performed outside the spinal column with adequate joint slack and without soft tissue pretension so that no joint cavitations occur. In some sessions, the participant lay either prone on a Zenith 2010 HYLO bench with the investigator standing at the participant’s right side with his left palm placed on the participant’s right lateral scapular edge with the other hand reinforcing. In other sessions, the investigator will stand at the participant’s left side and place his right palm over the participant’s left scapular edge with the left hand reinforcing, delivering a non-intentional lateral push manoeuvre. Alternatively, the participant lay in the same side posture position as the active treatment group with the bottom leg straight and the top leg flexed with the top leg’s ankle resting on the bottom leg’s knee fold, in preparation for a side posture push move, which will be delivered as a non-intentional push in the gluteal region. The sham manipulation alternatives will be equally interchanged among the placebo participants according to protocol during the 12-week treatment period to strengthen the study validity. The active and the placebo groups will receive the same structural and motion assessment prior to and after each intervention. No additional cointerventions or advice will be given to participants during the trial period. The treatment period will include 12 consultations, that is, twice per week in the first 3?weeks followed by once a week in the next 2?weeks and once every second week until 12?weeks are reached. Fifteen minutes will be allocated per consultation for each participant. All interventions will be conducted at the Akershus University Hospital and administered by an experienced chiropractor (AC).

Image of an older man receiving chiropractic care for migraine relief.

Dr Jimenez works on wrestler's neck_preview

The control group will continue usual care, that is, pharmacological management without receiving manual intervention by the clinical investigator. The same exclusion criteria apply for the control group during the whole study period.

Blinding

After each treatment session, the participants who receive active or placebo intervention will complete a de-blinding questionnaire administrated by an external trained independent party with no involvement from the clinical investigator, that is, providing a dichotomous �yes� or �no� answer as to whether active treatment was received. This response was followed by a second question regarding how certain they were that active treatment was received on a 0�10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certainty. The control group and the clinical investigator can for obvious reasons not be blinded.[49, 50]

Follow-Up

Follow-up analysis will be conducted on the end points measured after the end of intervention and at 3, 6 and 12?months follow-up. During this period, all participants will continue to fill in a diagnostic paper headache diary and return it on a monthly basis. In the case of unreturned diary or missing values in the diary, the participants will be contacted immediately on detection to minimise recall bias. Participants will be contacted by phone to secure compliance.

Primary and Secondary End Points

The primary and secondary end points are listed below. The end points adhere to the recommended IHS clinical trial guidelines.[32, 33] We define number of migraine days as the primary end point and expect at least a 25% reduction in average number of days from baseline to the end of intervention, with the same level of reduction being maintained at follow-up. On the basis of previous reviews on migraine, a 25% reduction is considered to be a conservative estimate.[30] A 25% reduction is also expected in secondary end points from baseline to the end of intervention, retaining at follow-up for migraine duration, migraine intensity and headache index, where the index is calculated as number of migraine days (30?days)�average migraine duration (hours per day)�average intensity (0�10 NRS). A 50% reduction in medication consumption from baseline to the end of intervention and to follow-up is expected.

Notes

Primary and Secondary End Points

Primary End Points

1. Number of migraine days in active treatment versus placebo group.
2. Number of migraine days in active treatment versus control group.

Secondary End Points

3. Migraine duration in hours in active treatment versus placebo group.
4. Migraine duration in hours in active treatment versus control group.
5. Self-reported VAS in active treatment versus placebo group.
6. Self-reported VAS in active treatment versus control group.
7. Headache index (frequency x duration x intensity) in active treatment versus placebo group.
8. Headache index in active treatment versus control group.
9. Headache medication dosage in active treatment versus placebo group.
10. Headache medication dosage in active treatment versus control group.

*The data analysis is based on the run-in period versus end of intervention. Point 11�40 will be duplicate of point 1�10 above at 3, 6 and 12?months follow-up, respectively.

Data Processing

A flow chart of the participants is shown in Figure 2. Baseline demographic and clinical characteristics will be tabulated as means and SDs for continuous variables and proportions and percentages for categorical variables. Each of three groups will be described separately. Primary and secondary end points will be presented by suitable descriptive statistics in each group and for each time point. Normality of end points will be assessed graphically and transformation will be considered if necessary.

Figure 2: Expected participant’s flow diagram. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

Change in primary and secondary end points from baseline to the end of intervention and to follow-up will be compared between the active and placebo groups and the active and control groups. The null hypothesis states that there is no significant difference between the groups in average change, while the alternative hypothesis states that a difference of at least 25% exists.

Owing to the follow-up period, repeated recordings of primary and secondary end points will be available, and analyses of trend in primary and secondary end points will be of main interest. Intra-individual correlations (cluster effect) are likely to be present in data with repeated measurements. Cluster effect will thus be assessed by calculating intraclass correlation coefficient quantifying the proportion of total variation attributable to the intraindividual variations. The trend in end points will be assessed by a linear regression model for longitudinal data (linear mixed model) to correctly account for the possible cluster effect. The linear mixed model handles unbalanced data, enabling all available information from randomised patients to be included, as well as from dropouts. Regression models with fixed effects for time component and group allocation as well as the interaction between the two will be estimated. The interaction will quantify possible differences between groups regarding time trend in the end points and serve as an omnibus test. Random effects for patients will be included to adjust the estimates for intraindividual correlations. Random slopes will be considered. The linear mixed models will be estimated by the SAS PROC MIXED procedure. The two pairwise comparisons will be performed by deriving individual time point contrasts within each group with the corresponding p values and 95% CIs.

Both per-protocol and intention-to-treat analyses will be conducted if relevant. All analyses will be performed by a statistician, blinded for group allocation and participants. All adverse effects will also be registered and presented. Participants who experience any sort of adverse effects during the trial period will be entitled to call the clinical investigator on the project cell phone. The data will be analysed with SPSS V.22 and SAS V.9.3. Owing to two group comparisons in the primary end point, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a significance level of 0.05 will be used. Missing values might appear in incomplete interview questionnaires, incomplete headache diaries, missed intervention sessions and/or due to dropouts. The pattern of missingness will be assessed and missing values handled adequately.

Power Calculation

Sample size calculations are based on the results in a recently published group comparison study on topiramate.[51] We hypothesise that the average difference in reduction of number of days with migraine per month between the active and the placebo groups is 2.5?days. The same difference is assumed between the active and control groups. SD for reduction in each group is assumed to be equal to 2.5. Under the assumption of, on average, 10 migraine days per month at baseline in each group and no change in the placebo or control group during the study, 2.5?days reduction corresponds to a reduction by 25%. Since primary analysis includes two group comparisons, we set a significance level at 0.025. A sample size of 20 patients is required in each group to detect a statistically significant average difference in reduction of 25% with 80% power. To allow for dropouts, the investigators plan to recruit 120 participants.

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

“I’ve been recommended to seek chiropractic care for my migraine-type headaches. Is chiropractic spinal manipulative therapy effective for migraine?”�Many different types of treatment options can be utilized to effectively treat migraine, however, chiropractic care is one of the most popular treatment approaches for naturally treating migraine. Chiropractic spinal manipulative therapy�is the traditional high-velocity low-amplitude (HVLA) thrust. Also known as spinal manipulation, a chiropractor performs this chiropractic technique by applying a controlled sudden force to a joint while the body is positioned in a specific way. According to the following article, chiropractic spinal manipulative therapy can effectively help treat migraine.

Discussion

Methodological Considerations

Current SMT RCTs on migraine suggest treatment efficacy regarding migraine frequency, duration and intensity. However, a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings.[30] Such studies should adhere to the recommended IHS clinical trial guidelines with migraine frequency as the primary end point and migraine duration, migraine intensity, headache index and medication consumption as secondary end points.[32, 33] The headache index, as well as a combination of frequency, duration and intensity, gives an indication of the total level of suffering. Despite the lack of consensus, the headache index has been recommended as an accepted standard secondary end point.[33, 52, 53] The primary and secondary end points will be collected prospectively in a validated diagnostic headache diary for all participants in order to minimise recall bias.[47, 48] To the best of our knowledge, this is the first prospective manual therapy in a three-armed single-blinded placebo-controlled RCT to be conducted for migraine. The study design adheres to the recommendations for pharmacological RCTs as far as possible. RCTs that include a placebo group and a control group are advantageous to pragmatic RCTs that compare two active treatment arms. RCTs also provide the best approach for producing safety as well as efficacy data.

Image of a woman with a migraine holding her head.

Unsuccessful blinding is a possible risk to the RCT. Blinding is often difficult as there is no single validated standardised chiropractic sham intervention which can be used as a control group for this date. It is, however, necessary to include a placebo group in order to produce a true net effect of the active intervention. Consensus about an appropriate placebo for a clinical trial of SMT among experts representing clinicians and academics has, however, not been reached.[54] No previous studies have, to the best of our knowledge, validated a successful blinding of a CSMT clinical trial with multiple treatment sessions. We intend to minimise this risk by following the proposed protocol for the placebo group.

The placebo response is furthermore high in pharmacological and assumed similarly high for non-pharmacological clinical studies; however, it might even be higher in manual therapy RCTs were attention and physical contact is involved.[55] Similarly, a natural concern with regard to attention bias will be involved for the control group as it is not being seen by anyone or not seen as much by the clinical investigator as the other two groups.

There are always risks for dropouts due to various reasons. Since the trial duration is 17?months with a 12?month follow-up period, the risk for loss to follow-up is thus enhanced. Co-occurrence of other manual intervention during the trial period is another possible risk, as those who receive manipulation or other manual physical treatments elsewhere during the trial period will be withdrawn from the study and regarded as dropouts at the time of violation.

The external validity of the RCT might be a weakness as there is only one investigator. However, we found that advantageous to multiple investigators, in order to provide similar information to participants in all three groups and manual intervention in the CSMT and the placebo groups. Thus, we intend to eliminate inter-investigator variability which might be present if there are two or more investigators. Although the Gonstead method is the second most commonly used technique among chiropractors, we do not see an issue of concern when it comes to generalisability and external validity. Furthermore, the block randomisation procedure will provide a homogeneous sample across the three groups.

The internal validity is, however, strong by having one treating clinician. It reduces the risk of potential selection, information and experimental biases. Furthermore, the diagnosis of all participants is performed by experienced neurologists and not by questionnaires. A direct interview has higher sensitivity and specificity as compared to a questionnaire.[27] Individual motivational factors which can influence a participant’s perception and personal preferences when treating are both reduced by having one investigator. In addition, the internal validity is further strengthened by a concealed validated randomisation procedure. Since age and genders may play a role in migraine, block randomisation was found necessary to balance arms by age and gender in order to reduce possible age-related and/or gender-related bias.

X-rays demonstrating loss of cervical lordosis as a possible cause for migraine.

Conducting X-rays prior to the active and placebo interventions was found to be applicable in order to visualise posture, joint and disc integrity.[56, 57] Since the total X-ray radiation dose varies from 0.2�0.8?mSv, the radiation exposure was considered low.[58, 59] X-ray assessments were also found to be necessary in order to determine if full spine X-rays are useful in future studies or not.

Since we are unaware of the mechanisms of possible efficacy, and both spinal cord and central descending inhibitory pathways have been postulated, we see no reasons to exclude a full spine treatment approach for the intervention group. It has furthermore been postulated that pain in different spinal regions should not be regarded as separate disorders but rather as a single entity.[60] Similarly, including a full spine approach limits the differentiations between the CSMT and the placebo groups. Thus, it might strengthen the likelihood of successful blinding in the placebo group being achieved. In addition, all the placebo contacts will be performed outside the spinal column, thus minimising a possible spinal cord afferent input.

Innovative and Scientific Value

This RCT will highlight and validate the Gonstead CSMT for migraineurs, which has not previously been studied. If CSMT proves to be effective, it will provide a non-pharmacological treatment option. This is especially important as some migraineurs do not have efficacy of prescript acute and/or prophylactic medications, while others have non-tolerable side effects or comorbidity of other diseases that contradict medication while others wish to avoid medication for various reasons. Thus, if CSMT works, it can really have an impact on migraine treatment. The study also bridges cooperation between chiropractors and physicians, which is important in order to make healthcare more efficient. Finally, our method might be applied in future chiropractic and other manual therapy RCTs on headache.

Ethics and Dissemination

Ethics

The study has been approved by the Norwegian Regional Committee for Medical Research Ethics (REK) (2010/1639/REK) and the Norwegian Social Science Data Services (11�77). The declaration of Helsinki is otherwise followed. All data will be anonymised while participants must give oral and written informed consent. Insurance is provided through �The Norwegian System of Compensation to Patients� (NPE), which is an independent national body set up to process compensation claims from patients who have suffered an injury as a result of treatment under the Norwegian health service. A stopping rule was defined for withdrawing participants from this study in accordance with recommendations in the CONSORT extension for Better Reporting of Harms.[61] If a participant reports to their chiropractor or research staff a severe adverse event, he or she will be withdrawn from the study and referred to their general practitioner or hospital emergency department depending on the nature of the event. The final data set will be available to the clinical investigator (AC), the independent and blinded statistician (JSB) and Study Director (MBR). Data will be stored in a locked cabinet at the Research Centre, Akershus University Hospital, Norway, for 5?years.

Dissemination

This project is due for completion 3?years after the start. Results will be published in peer-reviewed international scientific journals in accordance with the CONSORT 2010 Statement. Positive, negative, as well as inconclusive results will be published. In addition, a written lay summary of the results will be available to study participants on request. All authors should qualify for authorship according to the International Committee of Medical Journal Editors, 1997. Each author should have participated sufficiently in the work to take public responsibility for the content. The final decision on the order of authorship will be decided when the project has been finalised. The results from the study may, moreover, be presented as posters or oral presentations at national and/or international conferences.

Acknowledgments

Akershus University Hospital kindly provided research facilities. Chiropractor Clinic1, Oslo, Norway, performed X-ray assessments.

Footnotes

Contributors: AC and PJT had the original idea for the study. AC and MBR obtained funding. MBR planned the overall design. AC prepared the initial draft and PJT commented on the final version of the research protocol. JSB performed all the statistical analyses. AC, JSB, PJT and MBR were involved in the interpretation and assisted in the revision and preparation of the manuscript. All authors have read and approved the final manuscript.

Funding: The study has received funding from Extrastiftelsen (grant number: 2829002), the Norwegian Chiropractic Association (grant number: 2829001), Akershus University Hospital (grant number: N/A) and University of Oslo in Norway (grant number: N/A).

Competing interests: None declared.

Patient consent: Obtained.

Ethics approval: The Norwegian Regional Committee for Medical Research Ethics approved the project (ID of the approval: 2010/1639/REK).

Provenance and peer review: Not commissioned; externally peer reviewed.

A Randomized Controlled Trial of Chiropractic Spinal Manipulative Therapy for Migraine

Abstract

Objective: To assess the efficacy of chiropractic spinal manipulative therapy (SMT) in the treatment of migraine.

Design: A randomized controlled trial of 6 months’ duration. The trial consisted of 3 stages: 2 months of data collection (before treatment), 2 months of treatment, and a further 2 months of data collection (after treatment). Comparison of outcomes to the initial baseline factors was made at the end of the 6 months for both an SMT group and a control group.

Setting: Chiropractic Research Center of Macquarie University.

Participants: One hundred twenty-seven volunteers between the ages of 10 and 70 years were recruited through media advertising. The diagnosis of migraine was made on the basis of the International Headache Society standard, with a minimum of at least one migraine per month.

Interventions: Two months of chiropractic SMT (diversified technique) at vertebral fixations determined by the practitioner (maximum of 16 treatments).

Main Outcome Measures: Participants completed standard headache diaries during the entire trial noting the frequency, intensity (visual analogue score), duration, disability, associated symptoms, and use of medication for each migraine episode.

Results: The average response of the treatment group (n = 83) showed statistically significant improvement in migraine frequency (P < .005), duration (P < .01), disability (P < .05), and medication use (P< .001) when compared with the control group (n = 40). Four persons failed to complete the trial because of a variety of causes, including change in residence, a motor vehicle accident, and increased migraine frequency. Expressed in other terms, 22% of participants reported more than a 90% reduction of migraines as a consequence of the 2 months of SMT. Approximately 50% more participants reported significant improvement in the morbidity of each episode.

Conclusion: The results of this study support previous results showing that some people report significant improvement in migraines after chiropractic SMT. A high percentage (>80%) of participants reported stress as a major factor for their migraines. It appears probable that chiropractic care has an effect on the physical conditions related to stress and that in these people the effects of the migraine are reduced.

In conclusion, chiropractic spinal manipulative therapy can be used effectively to help treat migraine, according to the research study. Furthermore, chiropractic care improved the individual’s overall health and wellness. The well-being of the human body as a whole is believed to be one of the biggest factors as to why chiropractic care is effective for migraine. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Neck Pain

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References

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Close Accordion

Defeat Chronic Pain

by Dr Alex Jimenez | Complex Injuries, Conditions Treated, Mental Health

Defeat Chronic Pain: If you are one of the estimated 50 to 100 million Americans who struggles with Chronic Pain, you are aware of just how miserable and life-altering it can be. There is not a single area of you life that remains unaffected. You no longer sleep well. Your SEX LIFE is non-existent. Everyday activities have become your own personal �Mount Everest �. You cannot concentrate because the pain IS ALWAYS ON YOUR MIND. It is wearing you out, physically, mentally, and emotionally. It’s sapping your ability to think clearly or make decisions. In short we’re here to defeat chronic pain.

People can see the pain on your face and in your eyes. Chronic Pain and the inability to do the things you love, is making you feel DEPRESSED (not the other way around like your doctor may have suggested). Recent studies have even shown that brains of people suffering with Chronic Pain, show patterns of atrophy that are virtually indistinguishable from what is seen in patients with dementia or ALZHEIMER’S. In fact, a recent study from a prominent Canadian University showed that Chronic Pain causes the brain to degenerate at almost 10 times the rate of someone without pain!

Although Chronic Pain may seem hopeless, there are some things that you can do to help yourself � even though your doctor undoubtedly failed to educate you in this regard. Some of the most basic of these include eating only healthy foods (I recommend a PALEO DIET), taking only WHOLE FOOD SUPPLEMENTS, drinking more WATER, giving up the CIGARETTES, and EXERCISING to the degree that you can (difficult when suffering with Chronic Pain or FIBROMYALGIA).

Although DOING THESE SIMPLE THINGS will certainly help a large percentage who suffer and be able to defeat chronic pain; there is a significant percentage of you whose pain is not greatly diminished by these measures. It is for you that I created this website. But before we move on to treatment of Chronic Pain, you must first understand what Chronic Pain is and how it really works.

Defeat Chronic Pain: It Works Like This

For years, neuro-scientists have known that Chronic Pain can cause brain atrophy (shrinkage) that is indistinguishable from Alzheimer�s or Dementia. More recently, the prestigious Journal of Neuroscience reported research from McGill University showing that, “The longer the individual has had Fibromyalgia, the greater the gray matter loss, with each year of Fibromyalgia being equivalent to 9.5 times the loss in normal aging”. Think about this statement for a moment. Every single year you live with some sort of CHRONIC PAIN SYNDROME (or syndromes as the case may be) is the equivalent of nearly 10 times the brain loss seen in the normal aging process. Re-read this paragraph until the urgency of your situation sinks in!

Although there are several types of pain (the study of Chronic Pain can get extremely complex), we are going to try and keep this as simple as possible. For our purposes, there are two types of Chronic Pain. It has to do with where the pain comes from. Chronic Pain originates in one of the two following areas.

The Central Nervous System
The Body

As we will discuss shortly, Chronic Pain that arises in the CNS is frequently ‘learned’ pain. Let me explain. In order to learn how to SHOOT FREE THROWS, use chop sticks, PLAY THE PIANO, speak Swahili, you have to practice. Everyone remembers the old adage; Practice makes Perfect. If you stimulate pain pathways in the Brain & Nervous System long enough, or are exposed to enough stressors in your life (CHEMICAL, AUTOIMMUNE, EMOTIONAL, DIETARY, FOOD SENSITIVITIES, PHYSICAL, BACTERIAL, VIRAL, PARASITIC, FUNGAL, MOLD, ELECTROMAGNETIC, etc), you can alter the way your Brain and Central Nervous System function.

Hopefully your pain, even though severe, is still Type II (THE THREE TYPES OF PAIN). As people start losing control of numerous areas of physiology (DIGESTION, HORMONAL, IMMUNITY, BLOOD SUGAR REGULATION, HYPERSENSITIVITY, DYSBIOSIS, etc), the problems ramp up. Over time this pain can (will) become locked into the brain. Although pathological Pain Syndromes arising from a malfunctioning CNS are not the most common causes of Chronic Pain, if this is where you are at, you are going to have to find a way to deal with these underlying issues (FUNCTIONAL NEUROLOGY can be a fantastic starting point). Although I provide information that helps many people help themselves with the severe metabolic and neurological problems, this website is chiefly devoted to defeat chronic Pain that is not locked into the Brain, but is instead originating from the body (Type II Pain).

Defeat Chronic Pain: Nociception

“Simple Nociception” is the most basic type of pain. If someone steps on your toe, it hurts. This is normal, and means that your nervous system is functioning properly. Get the person off your toe, and the pain goes away — almost immediately. Simple. There are several different types of Nociceptive Pain, but the one that we are most concerned about on this website is the one that has to do with ‘deep’ musculoskeletal pain, otherwise known as Deep Somatic Pain (Greek �Soma� = body). Deep Somatic Pain is pain that originates in tissues that are considered to be ‘deep’ in the body. Although we do not always think of many of these tissue types as being deep, this category includes things like LIGAMENTS, TENDONS, MUSCLES, FASCIA, blood vessels, and bones. There are two main types of Nociceptors, chemical and mechanical.

I. Chemical Nociception

The Chemical Nociceptors are stimulated by noxious chemicals. The chief of these are the chemicals we collectively refer to as INFLAMMATION (bear in mind that once Inflammation is involved, we begin moving away from Type I pain and into Type II pain — Nociception is still involved, but so is the Inflammatory Cascade). Inflammation is actually made up of a large group of chemicals manufactured within your body as part of the normal Immune System response. They have names like prostaglandins, leukotrienes, histamines, cytokines, kinins, etc, etc, etc. When these chemicals are out of increased beyond what’s needed for normal tissue repair, the result will be a whole host of health problems —- and Chronic Pain.

Although “SYSTEMIC INFLAMMATION” is at the root of the vast majority of America’s health problems (DIABETES, CANCER, FIBROMYALGIA, THYROID PROBLEMS, ARTHRITIS, HEART DISEASE, and numerous others), you will soon see that even though Inflammation is always involved with the tissues of the “Deep Soma,” it sometimes gets more credit than it deserves. However, you also have to be aware that exposing MICROSCOPIC SCAR TISSUE to chronic inflammation can potentially hyper-sensitize nerves. This hypersensitization makes the nerves within Scar Tissue as much as 1,000 times more pain sensitive than normal (the work of the famous neurologist, DR. CHAN GUNN).

INCREASED TISSUE ACIDITY (usually caused by hypoxia — diminished tissue oxygen levels) is another common form of Chemical Nociception. This frequently occurs as the result of a JUNKY DIET, but is also caused by relentless Mechanical / Neurological / Immune System Dysfunction. It is a big reason that my Decompression Protocols utilize OXYGEN THERAPY extensively.

II. Mechanical Nociception

As you can imagine, Mechanical Dysfunction stimulates the Mechanical Nociceptors. This group of nociceptors (pain receptors) is stimulated by constant mechanical stress in the tissues of the Deep Soma — particularly ligaments, tendons, and fascia. Mechanical tension, mechanical deformation, mechanical pressure, etc are the things that cause Mechanical Nociception, which can in turn, cause pain — chronic, unrelenting, pain. Remove the offending mechanical stressor, and you can oftentimes remove the pain. Sounds simple, doesn�t it? Unfortunately, nothing is ever quite as simple as it initially appears.

Be aware that Nociceptive Pain can actually become Brain-Based over time. This is called ‘Supersensitivity’ and is caused by alterations in the Brain and Central Nervous System that perpetuate the pain cycle (many in the medical community are calling it CENTRALIZATION OR CENTRAL SENSITIZATION. In Mechanical Nociception, even though the injured tissue has, according to all of the medical tests, HEALED, it has healed improperly; i.e. microscopic scar tissue and tissue adhesion — particularly in the FASCIA. I probably do not need to tell you that this can be really really bad news — particularly because it is a significant feature of what I call “CHRONIC PAIN’S PERFECT STORM“.

As nerve function and PROPRIOCEPTION become increasingly fouled up, degenerative arthritis and joint deterioration begin to set in (HERE). Because of involvement in the Brain or Central Nervous System, this kind of pain is often referred to as Neuropathic Pain or Neruogenic Pain. Sometimes people end up with HYPERALGIA (Extreme sensitivity to pain. Stimulus that should cause a little pain, causes extraordinary amounts of pain). Or they end up with ALLODYNIA (Stimulus which do not normally elicit any pain at all, now causes pain). Sometimes these two overlap. Stay with me and you will begin to understand why.

Defeat Chronic Pain: Hypersensitized Nerves Relationship To Injured Or Damaged Fascia

Think of nerve endings as the twigs at the very end of a tree limb. Nerves (just like a tree) begin with a large trunk, which splits / divides into smaller and smaller branches until eventually you arrive at the end � the tiny twig (or nerve ending) at the end of the very smallest branches.

If you have ever seen a �topped� tree, you can understand what happens to nerve endings that are found in microscopic scar tissue. Professional Tree Trimmers cut (or �top�) the largest branches just above where the trunk splits into two or three limbs. What happens to these stubs? Instead of having limbs that continue to branch out and divide into ever-smaller limbs in a normal fashion, you get a stub or stump, that in a short matter of time, swells up and has hundreds of tiny twig-like limbs growing from it. �Topping� stimulates the growth of twigs from the stump. The injured nerves found in microscopic scar tissue act in much the same way.

As the larger nerves that are found in soft tissues are injured, you end up with an inordinate number of immature nerve endings (twigs) growing out of an inflamed nerve �stump�. As you might imagine, extra pain receptors are never a good thing! And because there in Inflammation present, this often leads to Microscopic Scar Tissue, which, even though it is up to 1,000 times more pain-sensitive than normal tissue, cannot be seen with even the most technologically advance imaging techniques such as CT / MRI (HERE). This is a commonly seen phenomenon in Facial Adhesions, and is why even though the people living this nightmare believe that because their pain is so severe that it should make their MRI “Glow Red”, it shows nothing. This tends to lead to deer-in-the-headlight looks when you ask your doctor what might be causing your pain, not to mention accusations of malingering, drug seeking, or attempting to get on Disability.

Defeat Chronic Pain: Nerves Are Like Tree Branches

Uninjured Nerves

Photo by Stephen McCulloch

Injured Nerves

Photo by Linda Bailey

Defeat Chronic Pain: Fascial Adhesions

Microscopic Scar Tissue & Chronic Pain

One of the biggest revelations for many people suffering with Chronic Pain is the absurd numbers of CHRONIC PAIN SYNDROMES brought on by microscopic scarring of the FASCIA. It gets even worse once you realize that this Fascia is the most pain-sensitive tissue in the body —- yet it does not show up on even the most technologically advanced imaging techniques, including MRI. Simply read our “Fascia” page to see why microscopic scarring of this specific “Connective Tissue” is at the root of all sorts of Chronic Pain Cases — not to mention ILL HEALTH.

Destroy Chronic Pain / Doctor Russell Schierling

Medical Inc Teaser

McKenzie Therapy for Acute Non-Specific Low Back Pain

by spinedoctors | Chiropractic, Conditions Treated, Functional Medicine, Lower Back Pain, Physical Rehabilitation

Have you ever experienced low back pain? If you haven’t already, there’s a high probability you will present at least one case of back pain sometime during your lifetime. Back pain is one of the most prevalent spine health issues reported among the population of the United States, affecting up to 80 percent of Americans at some point in their lives. Back pain is not a specific disease, rather it is a symptom which may develop as a result of a variety of injuries and/or conditions.�Although most cases typically resolve on their own, the effective treatment of acute low back pain is essential towards preventing chronic low back pain.

Chiropractors and physical therapists frequently utilize a similar series of treatment methods, such as spinal adjustments and manual manipulations as well as massage and physical therapy, to help treat symptoms of back and low back pain. Many healthcare professionals, however, have started using the McKenzie method to manage acute back pain. The purpose of the following article is to educate patients on the effectiveness of the McKenzie method for acute non-specific low back pain.

The McKenzie Method for the Management of Acute Non-Specific Low Back Pain: Design of a Randomised Controlled Trial

Abstract

Background

Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.

Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP.

Methods/Design

This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3.

Discussion

This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.

Background

In Australia, low back pain (LBP) is the most frequently seen musculoskeletal condition in general practice and the seventh most frequent reason for consulting a physician[1,2]. According to the Australian National Health Survey, 21% of Australians reported back pain in 2001; additionally, the Australian Bureau of Statistic’s 1998 Survey of Disability, Ageing and Carers estimated that over one million Australians suffer from some form of disability associated with back problems[1].

LBP poses an enormous economic burden to society in countries such as the USA, UK and The Netherlands[3]. In the largest state in Australia, New South Wales, back injuries account for 30% of the cost of workplace injuries, with a gross incurred cost of $229 million in 2002/03[4]. It is expected that most people with an acute episode of LBP will improve rapidly, but a proportion of patients will develop persistent lower levels of pain and disability[5,6]. Those patients with chronic complaints are responsible for most of the costs[6]. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.

There is a growing concern about effectiveness of treatments for LBP, as reflected in the large number of systematic reviews published in the last 5 years addressing this issue. [7-12]. Despite the large amount of evidence regarding LBP management, a definitive conclusion on which is the most appropriate intervention is not yet available. A comparison of 11 international clinical practice guidelines for the management of LBP showed that the provision of advice and information, together with analgesics and NSAIDs, is the approach consistently recommended for patients with an acute episode[13]. Most guidelines do not recommend specific exercises for acute LBP because trials to date have concluded that it is not more effective than other active treatments, or than inactive or placebo treatments[8]. However, some authors have suggested that the negative results observed in trials of exercises are a consequence of applying the same exercise therapy to heterogeneous groups of patients. [14-16]. This hypothesis has some support from a recent high-quality randomised trial in which treatment based on a diagnostic classification system led to larger reductions in disability and promoted faster return to work in patients with acute LBP than the therapy recommended by the clinical guidelines[17].

In 1981, McKenzie proposed a classification system and a classification-based treatment for LBP labelled Mechanical Diagnosis and Treatment (MDT), or simply McKenzie Method[18]. Of the large number of classification schemes developed in the last 20 years [19-26], the McKenzie Method has the greatest empirical support (e.g. validity, reliability and generalisability) among the systems based on clinical features[27] and therefore seems to be the most promising classification system for implementation in clinical practice.

Physiotherapists commonly adopt the McKenzie Method for treating patients with LBP[28,29]. A survey of 293 physiotherapists in 1994 found that 85% of them perceived the McKenzie Method as moderately to very effective[28]. Nevertheless, a recent systematic review concluded that there is insufficient evidence to evaluate the effectiveness of the McKenzie Method for patients with LBP [30]. A critical concern is that most trials to date have not implemented the McKenzie Method appropriately. The most common flaw is that all trial participants are given the same intervention regardless of classification, an approach contradictory to the principles of McKenzie therapy.

The primary aim of this trial is to evaluate whether the addition of the McKenzie Method to general practitioner (GP) care results in better outcomes than GP care alone for patients with acute non-specific LBP when effect is measured in terms pain, disability, global perceived effect, and persistent symptoms.

Methods

The University of Sydney Human Research Ethics Committee granted approval for this study.

Study Sample

One hundred and forty eight participants with a new episode of acute non-specific LBP who present to GPs will be recruited for the study. A new episode of LBP will be defined as an episode of pain lasting longer than 24 hours, preceded by a period of at least one month without LBP and in which the patient did not consult a health care practitioner[31]. Participants will be screened for eligibility at their first appointment with the GP according to the inclusion and exclusion criteria.

Inclusion Criteria

To be eligible for inclusion, participants must have pain extending in an area between the twelfth rib and buttock crease (this may or may not be accompanied by leg pain); pain of at least 24 hours duration; pain of less than 6 weeks duration; and they need to be eligible for referral to private physiotherapy practice within 48 hours.

Exclusion Criteria

Participants will be excluded if they have one of the following conditions: nerve root compromise (defined as 2 positive tests out of sensation, power and reflexes for the same spinal nerve root); known or suspected serious spinal pathology; spinal surgery within the preceding 6 months; pregnancy; severe cardiovascular or metabolic disease; or inability to read and understand English.

Recruiting GPs will record the number of patients who are invited to participate, the number who decline to participate, and the number of screened patients who are ineligible and their reasons for declining participation or ineligibility. Written consent will be obtained for each participant.

Subjects who volunteer to participate and satisfy the eligibility criteria will receive baseline treatment and then be randomly allocated to one of the study groups. To ensure equal-sized treatment groups, random permuted blocks of 4�8 participants will be used[32]. Randomisation will be stratified by Workcover compensation status. The stratified random allocation schedule will be generated by a person not otherwise involved in recruitment, assessment or treatment of subjects and the randomisation sequence will be placed in sequentially numbered, sealed envelopes. The flow of participants through the study is detailed in Figure ?1.

Figure 1: Flow of participants through the study. Legend: GP � General practitioner; NRS � Numeric pain rating scale; PSFS � Patient-specific functional scale; RMQ � Roland-Morris questionnaire; GPE � Global perceived effect; LBP � Low back pain.

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

In the management of low back pain, the attitudes, beliefs and treatment preferences of chiropractors, as well as that of physical therapists, can determine the most effective outcome measures in the care of patients with different types of spinal health issues. According to the following evidence-based research studies, the McKenzie method has been deemed to be one of the most useful treatment approaches for managing symptoms in patients with back and low back pain. Exercise and physical activity is also one of the most common treatment preferences for improving an individual’s strength, mobility and flexibility. Every healthcare professional varies in respect to their specific treatment preferences. These variations emphasize the need to identify the most effective treatment approach to guarantee proper treatment of LBP.

Outcome Measures

The McKenzie protocol is thought to promote rapid symptom improvement in patients with LBP[33,34] and this is one of the reasons that therapists choose this therapy. Therefore it is important to focus assessment on short-term outcomes. The primary outcomes will be:

Usual pain intensity over last 24 hours recorded each morning in a pain diary over the first week. Pain will be measured on a 0�10 numerical rating scale (NRS). The unit of analysis will be the mean of the 7 measures[35];
Usual pain intensity over last 24 hours (0�10 NRS) recorded at 1 and 3 weeks[35];
Global perceived effect (0�10 GPE) recorded at 3 weeks.

The secondary outcomes will be:

Global perceived effect (0�10 GPE) recorded at 1 week;
Patient-generated measure of disability (Patient-Specific Functional Scale; PSFS) recorded at 1 and 3 weeks[36];
Condition-specific measure of disability (Roland Morris Questionnaire; RMQ) recorded at 1 and 3 weeks[37];
Number of patients reporting persistent back pain at 3 months.

Following the screening consultation in which the inclusion and exclusion criteria are assessed, the GP will supervise the baseline measurement of pain. All patients will then receive an assessment booklet and a pre-paid envelope in which all other self-assessed outcome measures are to be recorded and sealed. One member of the research team will contact patients by telephone within 24 hours of the consultation with the GP in order to give explanations regarding the appropriate form of filling in the assessment booklet. At this time, other baseline outcomes will be recorded and then the patient will be randomised to study groups. The patient will be advised to keep the booklet at home, to seal it into the pre-paid envelope after the final assessment and mail the sealed envelope to the research team. To ensure the proper use of the assessment booklet and to avoid loss of data due to non-returned booklets, a blinded assessor will contact all patients by telephone 9 and 22 days after the consultation with the GP to collect patient’s answers from the 1st week and 3rd week assessments, respectively.

The procedure for obtaining outcome data will be followed for all participants, regardless of compliance with trial protocols. At 3 months, data regarding the presence of persistent (chronic) symptoms will be collected by telephone. Participants will be asked to answer the following yes-no question: “During the past 3 months have you ever been completely free of low back pain? By this I mean no low back pain at all and would this pain-free period have lasted for a whole month”. Those answering no will be considered to have persistent LBP. Information on additional treatment and the direct costs with low back pain management will also be collected at 3 months.

A secondary analysis will be performed on predictors of response to McKenzie treatment and prediction of chronicity. This will involve the measurement of participants’ expectation about the helpfulness of both treatments under investigation as well as information on the occurrence of the centralisation phenomenon. Expectation will be recorded prior to randomisation according to the procedures described by Kalauokalani et al[38].

Treatments

All participants will receive GP care as advocated by the NHMRC guideline for the management of acute musculoskeletal pain[2]. Guideline-based GP care consists of providing information on a favourable prognosis of acute LBP and advising patients to stay active, together with the prescription of paracetamol. Patients randomised to the experimental group will be referred to physiotherapy to receive the McKenzie Method. A research assistant not involved in the assessment or treatment of subjects will be responsible for the randomisation process and will contact therapists and patients to arrange the first physiotherapy session. The McKenzie treatment will be delivered by credentialed physiotherapists who will follow the treatment principles described in McKenzie’s text book[18]. All therapists will have completed the four basic courses taught by the McKenzie Institute International. To ensure the appropriate implementation of the McKenzie’s classification algorithm, a training session with a member of McKenzie’s educational program will be conducted prior to the commencement of the study. The treatment frequency will be at the discretion of the therapist with a maximum of 7 sessions over 3 weeks. We chose to restrict the McKenzie treatment to a maximum of 7 sessions based on the study of Werneke and colleagues[39], which concluded that further reductions in pain and function are not expected if favourable changes in pain location are not present until the seventh treatment visit. Treatment procedures from the McKenzie Method are summarised in the Appendix.

Participants randomised to the control group will continue their GP care as usual. All participants regardless of intervention group will be advised not to seek other treatments for their low back pain during the treatment period. Physiotherapists will be asked to withhold co-interventions during the course of the trial.

Several mechanisms will be used to ensure that the trial protocol is applied consistently. Protocol manuals will be developed and all involved researchers (GPs, physiotherapists, assessor, and statistician) will be trained to ensure that screening, assessment, random allocation and treatment procedures are conducted according to the protocol. A random sample of treatment sessions will be audited to check that treatment is being administered according to the protocol.

Dr Jimenez helping man stretch_preview

Data Analysis

Power was calculated based on the primary outcome measures (pain intensity and global perceived effect). A sample size of 148 participants will provide 80% power to detect a difference of 1 unit (15%) on a 0�10 pain scale (SD = 2.0) between the experimental and control groups, assuming alpha of 0.05. This allows for loss to follow-up of 15%. This sample size also allows the detection of a difference of 1.2 units (12%) on a 0�10 global perceived effect scale (SD = 2.4).

Data will be analysed by a research member blinded to group status. The primary analysis will be by intention-to-treat. In order to estimate treatment effects, between-group mean differences (95%CI) will be calculated for all outcome measures. In the primary analysis these will be calculated using linear models that include baseline values of outcome variables as covariates to maximise precision.

Discussion

We have presented the rationale and design of an RCT evaluating the effects of the McKenzie Method in the treatment of acute non-specific LBP. The results of this trial will be presented as soon as they are available.

Competing Interests

The author(s) declare that they have no competing interests.

Authors’ Contributions

LACM, CGM and RDH were responsible for the design of the study. HC was responsible for recruiting McKenzie therapists and she will also participate as a clinician in the trial. LACM and JMc will act as trial coordinators. All authors have read and approved the final manuscript.

Appendix

Clinical picture and treatment principles according to the McKenzie Method

This table summarises the procedures involved in the McKenzie Method (Table 1). For detailed description of all procedures and progressions, refer to McKenzie’s text book. This is particularly important for Derangement syndrome since the treatment is extremely variable and complex and the full description of procedures would not be appropriate for the purposes of this paper.

Pre-Publication History

The pre-publication history for this paper can be accessed here: www.biomedcentral.com/1471-2474/6/50/prepub

Acknowledgements

The authors thank the physiotherapists credentialed in the McKenzie Method for their participation in this project.

Managing Low Back Pain: Attitudes & Treatment Preferences of Physical Therapists & Chiropractors

Abstract

Background and Purpose:�Researchers surveyed physical therapists about their attitudes, beliefs, and treatment preferences in caring for patients with different types of low back pain problems.

Subjects and Methods: Questionnaires were mailed to all 71 therapists employed by a large health maintenance organization in western Washington and to a random sample of 331 other therapists licensed in the state of Washington.

Results: Responses were received from 293 (74%) of the therapists surveyed, and 186 of these claimed to be practicing in settings in which they treat patients who have back pain. Back pain was estimated to account for 45% of patient visits. The McKenzie method was deemed the most useful approach for managing patients with back pain, and education in body mechanics, stretching, strengthening exercises, and aerobic exercises were among the most common treatment preferences. There were significant variations among therapists in private practice, hospital-operated, and health maintenance organization settings with respect to treatment preferences, willingness to take advantage of the placebo effect, and mean number of visits for patients with back pain.

Conclusions and Discussion: These variations emphasize the need for more outcomes research to identify the most effective treatment approaches and to guide clinical practice.

In conclusion,�the effective treatment of acute low back pain is essential because it can potentially help prevent the development of chronic low back pain. A growing number of chiropractors and physical therapists, including other healthcare professionals, have utilized the McKenzie method to help manage acute non-specific low back pain in patients. According to the research study, further evidence is required to support the use of the McKenzie method for LBP, however, the outcome measures of the research study regarding the effectiveness of the McKenzie method for low back pain are promising. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Sciatica

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

blog picture of cartoon paperboy big news

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

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Surgical vs Nonoperative Treatment for Lumbar Disk Herniation Using The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial

Abstract

Methods

Study Design

Patient Population

Study Interventions

Study Measures

Recruitment, Enrollment, and Randomization

Statistical Analyses

Results

Patient Characteristics

Nonoperative Treatments

Surgical Treatment and Complications

Nonadherence

Missing Data

Intent-to-Treat Analyses

Dr. Alex Jimenez’s Insight

Comment

Conclusion

Acknowledgments & Footnotes

Manipulation or Microdiskectomy for Sciatica? A Prospective Randomized Clinical Study

Abstract

Additional Topics: Back Pain

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References

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A Structured Physiotherapy Treatment Model Can Provide Rapid Relief to Patients Who Qualify for Lumbar Disc Surgery: A Prospective Cohort Study

Abstract

Introduction

Material and Methods

A Structured Physiotherapy Treatment Model

Study Outcome Measures

Statistical Analyses

Results

Change Over Time in Primary Outcome Measures

Change in Secondary Outcome Measures Over Time

Satisfaction with Treatment

Dr. Alex Jimenez’s Insight

Discussion

Acknowledgements

Additional Topics: Neck Pain

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References

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Constipation & Sciatica:

The Facts: Sciatica & Constipation

Constipation/Sciatica: Solutions

Sciatica/Constipation: Analysis

Sciatica?

Solving The Problem:

Pain Reduction:

Rules To Remember:

Good Nutrition & Chiropractic Treatment Contribute To Overall Well-Being

Clinical Application of Neuromuscular Techniques: Infraspinatus

Assessment of Shortness in the Infraspinatus

Assessment for Infraspinatus Weakness

MET Treatment of Infraspinatus

Additional Topics: Wellness

Chiropractic Spinal Manipulative Therapy for Migraine: a Study Protocol of a Single-Blinded Placebo-Controlled Randomised Clinical Trial

Abstract

Introduction

Method and Analysis

Ethics and Dissemination

Trial Registration Number

Strengths and Limitations of this Study

Background

Notes

The International Classification of Headache Disorders-II Diagnostic Criteria for Migraine

Method and Design

Patient Population

Clinical RCT

Run-In

Randomisation

Intervention

Blinding

Follow-Up

Primary and Secondary End Points