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Randomized Controlled Trial

Back Clinic Randomized Controlled Trial Chiropractic and Functional Medicine Team. A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions. Using the chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly.

At the time of the trial, it is not known which treatment is best. A Randomized Controlled Trial or (RCT) design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference from the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.

Advantages

  • Easier to blind/mask than from observational studies
  • Good randomization washes out any population bias
  • Populations of participating individuals are clearly identified
  • Results can be analyzed with well known statistical tools

Disadvantages

  • Does not reveal causation
  • Expensive in time and money
  • Loss to follow-up attributed to treatment
  • Volunteer biases: the population that participates may not be representative of the whole

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

Herniated Disc & Sciatica Nonoperative Treatment in El Paso, TX

by | 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

 

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.

 

Table 1 Patient Baseline Demographics

 

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.

 

Table 2 Nonoperative Treatments

 

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.

 

Table 3 Operative Treatments, Complications and Events

 

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.

 

Table 4 Statistically Significant Baseline Demographics

 

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

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

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

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

 

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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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Close Accordion
Migraine Pain & Lumbar Herniated Disc Treatment in El Paso, TX

Migraine Pain & Lumbar Herniated Disc Treatment in El Paso, TX

by | Cohort Studies, Herniated Disc, Migraine, Randomized Controlled Trial, Spinal Decompression Treatments, Treatments

One of the most prevalent causes of lower back pain and sciatica may be due to the compression of the nerve roots in the low back from a lumbar herniated disc, or a ruptured disc in the lumbar spine. Common symptoms of lumbar herniated discs include varying intensities of pain, muscle spasms or cramping, sciatica and leg weakness as well as loss of proper leg function. While these may not appear to be closely associated with each other, a lumbar herniated disc may also affect the cervical spine, manifesting symptoms of migraine and headache. The purpose of the following articles is to educate patients and demonstrate the relation between migraine pain and lumbar herniated disc, further discussing the treatment of these two common conditions.

 

A Critical Review of Manual Therapy Use for Headache Disorders: Prevalence, Profiles, Motivations, Communication and Self-Reported Effectiveness

 

Abstract

 

Background

 

Despite the expansion of conventional medical treatments for headache, many sufferers of common recurrent headache disorders seek help outside of medical settings. The aim of this paper is to evaluate research studies on the prevalence of patient use of manual therapies for the treatment of headache and the key factors associated with this patient population.

 

Methods

 

This critical review of the peer-reviewed literature identified 35 papers reporting findings from new empirical research regarding the prevalence, profiles, motivations, communication and self-reported effectiveness of manual therapy use amongst those with headache disorders.

 

Results

 

While available data was limited and studies had considerable methodological limitations, the use of manual therapy appears to be the most common non-medical treatment utilized for the management of common recurrent headaches. The most common reason for choosing this type of treatment was seeking pain relief. While a high percentage of these patients likely continue with concurrent medical care, around half may not be disclosing the use of this treatment to their medical doctor.

 

Conclusions

 

There is a need for more rigorous public health and health services research in order to assess the role, safety, utilization and financial costs associated with manual therapy treatment for headache. Primary healthcare providers should be mindful of the use of this highly popular approach to headache management in order to help facilitate safe, effective and coordinated care.

 

Keywords: Headache, Migraine, Tension headache, Cervicogenic headache, Manual therapy, Physical therapy, Chiropractic, Osteopathy, Massage

 

Background

 

The co-occurrence of tension headache and migraine is very high [1]. Respectively, they are the second and third most common disorders worldwide with migraine ranking as the seventh highest specific cause of disability globally [2] and the sixteenth most commonly diagnosed condition in the US [3]. These common recurrent headache disorders place a considerable burden upon the personal health, finances and work productivity of sufferers [3�5] with migraine further complicated by an association with cardiovascular and psychiatric co-morbidities [6, 7].

 

Preventative migraine drug treatments include analgesics, anticonvulsants, antidepressants and beta-blockers. Preventative drug treatments for tension-type headaches can include analgesics, NSAIDs, muscle relaxants and botulinum toxin as well as anticonvulsants and antidepressants. While preventative drug treatments are successful for a significant proportion of sufferers, headache disorders are still reported as under-diagnosed and under-treated within medical settings [8�16] with other studies reporting sufferers can cease continuing with preventative headache medications long-term [9, 17].

 

There is a number of non-drug approaches also utilized for the prevention of headaches. These include psychological therapies such as cognitive behavioral therapy, relaxation training and EMG (electromyography) biofeedback. In addition, there is acupuncture, nutritional supplementation (including magnesium, B12, B6, and Coenzyme Q10) and physical therapies. The use of physical therapies is significant, with one recent global survey reporting physical therapy as the most frequently used �alternative or complementary treatment� for headache disorders across many countries [18]. One of the most common physical therapy interventions for headache management is manual therapy (MT), [19�21] which we define here as treatments including �spinal manipulation (as commonly performed by chiropractors, osteopaths, and physical therapists), joint and spinal mobilization, therapeutic massage, and other manipulative and body-based therapies� [22].

 

Positive results have been reported in many clinical trials comparing MT to controls [23�27], other physical therapies [28�30] and aspects of medical care [31�34]. More high quality research is needed however to assess the efficacy of MT as a treatment for common recurrent headaches. Recent systematic reviews of randomized clinical trials of MT for the prevention of migraine report a number of significant methodological short-comings and the need for more high quality research before any firm conclusions can be made [35, 36]. Recent reviews of MT trials for tension-type headache and cervicogenic headache are cautious in reporting positive outcomes and the strong need for further robust research [37�41]. Despite the limited clinical evidence there has been no critical review of the significant use of MT by headache populations.

 

Methods

 

The aim of this study is to report from the peer-reviewed literature; 1) the prevalence of MT use for the treatment of common recurrent headaches and 2) factors associated with this use across several key themes. The review further identifies key areas worthy of further research in order to better inform clinical practice, educators and healthcare policy within this area.

 

Design

 

A comprehensive search of peer-reviewed articles published in English between 2000 and 2015 reporting new empirical research findings of key aspects of MT use among patients with migraine and non-migraine headache disorders was undertaken. Databases searched were MEDLINE, AMED, CINAHL, EMBASE and EBSCO. The key words and phrases used were: �headache�, �migraine�, �primary headache�, �cephalgia�, �chronic headache� AND �manual therapy�, �spinal manipulation�, �manipulative therapy�, �spinal mobilization�, �chiropractic�, �osteopathy�, �massage�, �physical therapy� or �physiotherapy� AND then �prevalence�, �utilization� or �profile� was used for additional searches against the previous terms. The database search was accompanied by a hand search of prominent peer-reviewed journals. All authors accessed the reviewed literature (data) and provided input to analysis.

 

Due to the focus of the review, literature reporting randomized control trials and similar clinical research designs were excluded as were articles identified as letters, correspondence, editorials, case reports and commentaries. Further searches were undertaken of the bibliographies in the identified publications. All identified articles were screened and only those reporting new empirical findings on MT use for headache in adults were included in the review. Articles identified and selected for the review were research manuscripts mostly within epidemiological and health economics studies. The review includes papers reporting MT use pooled with the use of other therapies, but only where MT patients comprised a large proportion (as stated) of the included study population. Results were imported into Endnote X7 and duplicates removed.

 

Search Outcomes, Analyses and Quality Appraisal

 

Figure 1 outlines the literature search process. The initial search identified 3286 articles, 35 of which met the inclusion criteria. Information from each article was organized into a review table (Table 1) to summarise the findings of the included papers. Information is reported under two selected headache groups and within each individual MT profession – chiropractic, physiotherapy, osteopathy and massage therapy � where sufficient detail was available.

 

Figure 1 Flow Chart of Study Selection

Figure 1: Flow Chart of Study Selection.

 

Table 1 Research Based Studies of Manual Therapy Use

Table 1: Research-based studies of manual therapy use for headache disorders.

 

An appraisal of the quality of the articles identified for review was conducted using a quality scoring system (Table 2) developed for the critical appraisal of health literature used for prevalence and incidence of health problems [42] adapted from similar studies [43�45]. This scoring system was applicable to the majority of study designs involving surveys and survey-based structured interviews (29 of the 35 papers) but was not applicable to a small number of included studies based upon clinical records, secondary analysis or practitioner characteristics.

 

Table 2 Description of Quality Criteria and Scoring

 

Two separate authors (CM and JA) independently searched and scored the articles. Score results were compared and any differences were further discussed and resolved by all the authors. The quality score of each relevant article is reported in Table 3.

 

Table 3 Quality Score for Selected Studies

 

Results

 

The key findings of the 35 articles were grouped and evaluated using a critical review approach adapted from previous research [46, 47]. Based on the limited information available for other headache types, prevalence findings are reported within one of two categories – either as �migraine� for papers reporting studies where the population was predominately or entirely made up of migraine patients or as �headache� for papers where the study population was predominately other headache types (including tension-type headaches, cluster headaches, cervicogenic headache) and/or where the headache type was not clearly stated. Ten papers reported findings examining prevalence rates for the �migraine� category alone, 18 papers reported findings examining prevalence for the �headache� category alone and 3 papers reported findings for both categories. Based on the nature of the information available, prevalence use was categorised by manual therapy providers. The extracted data was then analysed and synthesized into four thematic categories: prevalence; profile and motivations for MT use; concurrent use and order of use of headache providers; and self-reported evaluation of MT treatment outcomes.

 

Prevalence of MT Use

 

Thirty-one of the reviewed articles with a minimum sample size (>100) reported findings regarding prevalence of MT use. The prevalence of chiropractic use for those with migraine ranged from 1.0 to 36.2% (mean: 14.4%) within the general population [19�21, 48�52] and from 8.9 to 27.1% (mean: 18.0%) within headache-clinic patient populations [53, 54]. The prevalence of chiropractic use for those reported as headache ranged from 4 to 28.0% (mean: 12.9%) within the general population [20, 48, 51, 55�57]; ranged from 12.0 to 22.0% (mean: 18.6%) within headache/pain clinic patient populations [58�60] and from 1.9 to 45.5% (mean: 9.8%) within chiropractic patient populations [61�69].

 

The prevalence use of physiotherapy for those with migraine ranged from 9.0 to 57.0% (mean: 24.7%) within the general population [19, 20, 48, 52] and from 4.9 to 18.7% (mean: 11.8%) within headache-clinic patient populations [54, 70]. The prevalence use of physiotherapy for those reported as headache ranged from 12.2 to 52.0% (mean: 32.1%) within the general population [20, 48] and from 27.8 to 35.0%% (mean: 31.4%) within headache/pain clinic populations [60, 70].

 

Massage therapy use for those with migraine ranged from 2.0 to 29.7% (mean: 15.6%) within the general population [49, 50, 71] and from 10.1 to 56.4% (mean: 33.9%) within headache-clinic populations [53, 54, 72, 73]. Massage/acupressure use for those reported as headache within headache/pain clinic patient populations ranged from 12.0 to 54.0% (mean: 32.5%) [58�60, 70].

 

Osteopathy use for those with migraine was reported as 1% within the general population [49]; as 2.7% within a headache-clinic patient population [53] and as 1.7% within an osteopathy patient population [74]. For headache the prevalence was 9% within a headache/pain clinic population [60] and ranged from 2.7 to 10.0% (mean: 6.4%) within osteopathy patient populations [74, 75].

 

The combined prevalence rate of MT use across all MT professions for those with migraine ranged from 1.0 to 57.0% (mean: 15.9%) within the general population; ranged from 2.7 to 56.4% (mean: 18.4%) within headache-clinic patient populations and was reported as 1.7% in one MT patient population. The combined prevalence rate of MT use across all MT professions for those reported as headache ranged from 4.0 to 52.0% (mean: 17.7%) within the general population; ranged from 9.0 to 54.0% (mean: 32.3%) within headache-clinic patient populations and from 1.9 to 45.5% (mean: 9.25%) within MT patient populations.

 

Profile and Motivations for MT Use

 

While patient socio-demographic profiles were not reported within headache populations that were exclusively using MT, several studies report these findings where MT users made up a significant percentage of the non-medical headache treatments utilized by the study population (range 40% � 86%: mean 63%). While findings varied for level of income [58, 70] and level of education, [70, 72, 73] this patient group were more likely to be older [70, 72], female [20], have a higher rate of comorbid conditions [58, 70, 76] and a higher rate of previous medical visits [20, 58, 70] when compared to the non-user group. Overall, this group were reported to have a higher level of headache chronicity or headache disability than non-users [20, 54, 58, 70, 72, 77].

 

Several studies within headache-clinic populations report patient motivations for the use of complementary and alternative headache treatments where MT users made up a significant proportion of the study population (range 40% � 86%: mean 63%) [58, 70, 72, 78]. From these studies the most common motivation reported by study patients was �seeking pain relief� for headache which accounted for 45.4% � 84.0% (mean: 60.5%) of responses. The second most common motivation was patient concerns regarding the �safety or side effects� of medical headache treatment, accounting for 27.2% � 53.0% (mean: 43.8%) of responses [58, 70, 72]. �Dissatisfaction with medical care� accounted for 9.2% � 35.0% (mean: 26.1%) of responses [58, 70, 72].

 

A limited number of reviewed papers (all from Italy) report on the source of either the referral or recommendation to MT for headache treatment [53, 58, 59]. From these studies, referral from a GP to a chiropractor ranged from 50.0 to 60.8% (mean: 55.7%), while referral from friends/relatives ranged from 33.0 to 43.8% (mean: 38.7%) and self-recommendation ranged from 0 to 16.7% (mean: 5.6%). For massage therapy, referral from a GP ranged from 23.2 to 50.0% (mean: 36.6%), while referral from friends/relatives ranged from 38.4 to 42.3% (mean: 40.4%) and self-recommendation ranged from 7.7 to 38.4% (mean: 23.1%). For acupressure, referral from a GP ranged from 33.0 to 50.0% (mean: 41.5%), while referral from friends/relatives was reported as 50% and self-recommendation ranged from 0 to 16.6% (mean: 8.3%). One study reported findings for osteopathy where referral from both GP�s and friends/relatives was reported as 42.8% and self-recommendation was reported as 14.4%. Overall, the highest proportion of referrals within these studies was from GPs to chiropractors for chronic tension-type headache (56.2%), cluster headache (50%) and migraine (60.8%).

 

Concurrent Use and Order of Use of Headache Providers and Related Communication of MT Users

 

Several studies report on the concurrent use of medical headache management with complementary and alternative therapies. In those studies where the largest percentage of the patient population were users of MT�s (range 57.0% � 86.4%: mean 62.8%), [58, 70, 78] concurrent use of medical care ranged between 29.5% and 79.0% (mean: 60.0%) of the headache patient population.

 

These studies further report on the level of patient non-disclosure to medical providers regarding the use of MT for headache. Non-disclosure ranged between 25.5 and 72.0% (mean: 52.6%) of the patient population, with the most common reason for non-disclosure reported as the doctor �never asking�, ranging from 37.0 to 80.0% (mean: 58.5%). This was followed by a patient belief that �it was not important for the doctor to know� or �none of the doctor�s business�, ranging from 10.0 to 49.8% (mean: 30.0%). This was followed by a belief that either �the doctor would not understand� or �would discourage� these treatments, ranging from 10.0 to 13.0% (mean: 11.5%) [53, 77].

 

One large international study reported the ordering of the typical provider of headache care by comparing findings between several countries for migraine patients [21]. Primary care providers followed by neurologists were reported as the first and second providers for migraine treatment for nearly all countries examined. The only exception was Australia, where those with chronic migraine selected chiropractors as typical providers at equal frequency to neurologists (14% for both) while those with episodic migraine selected chiropractors at a greater frequency to neurologists (13% versus 5%). Comparatively, chiropractors were selected as the typical provider for those with chronic migraine by 10% in USA and Canada, 1% in Germany and 0% for UK and France. Chiropractors were selected as the typical provider for those with episodic migraine by 7% in USA, 6% in Germany, 4% in Canada and by 1% in both the UK and France.

 

Self-Reported Effectiveness of MT Treatment Outcomes

 

Several headache and pain-clinic population studies provide findings for the self-reported effectiveness of MT headache treatment. For chiropractic, patient self-reporting of partially effective or fully effective headache relief ranged from 27.0 to 82.0% (mean: 45.0%) [53, 58�60, 78]. For massage therapy, patient self-reporting of partially effective or fully effective headache relief ranged from 33.0 to 64.5% (mean: 45.2%)[53, 58, 60, 73, 78], and for acupressure this ranged from 33.4 to 50.0% (mean: 44.5%) [53, 58, 59]. For osteopathy and physiotherapy, one study reported effectiveness as 17 and 36% respectively [60].

When results are combined across all MT professions the reporting of MT as either partially or fully effective ranged from 17.0 to 82.0% (mean 42.5%) [53, 58�60, 73, 78]. In addition, one general population study provides findings for the self-reported effectiveness for chiropractic and physiotherapy at 25.6 and 25.1% respectively for those with primary chronic headache and 38 and 38% respectively for those with secondary chronic headache [79].

 

Discussion

 

This paper provides the first critical integrative review on the prevalence and key factors associated with the use of MT treatment for headaches within the peer-reviewed literature. While study methodological limitations and lack of data prevent making strong conclusions, these findings raise awareness of issues of importance to policy-makers, educators, headache providers and future research.

 

Our review found that MT use was generally higher within medical headache-clinic populations when compared to general populations. However, the use of individual MT providers does vary between different regions and this is likely due to a number of factors including variation in public access, healthcare funding and availability of MT providers. For example, the use of physiotherapy for some headache types may be relatively higher in parts of Europe [20, 60] while the use of chiropractors for some headache types may be relatively higher in Australia and the USA [19, 21]. Overall, the prevalence use of MT for headache appears to be substantial and likely to be the most common type of physical therapy utilized for headache in many countries [19�21, 49]. More high quality epidemiological studies are needed to measure the prevalence of MT use across different headache types and sub-types, both within the general population and clinical populations.

 

Beyond prevalence, data is more limited regarding who, how and why headache patients seek MT. From the information available however, the healthcare needs of MT headache patients may be more complex and multi-disciplinary in nature compared to those under usual medical care alone. Socio-demographic findings suggest that users of MT and other complementary and alternative therapies have a higher level of headache disability and chronicity compared to non-users. This finding may correlate with the higher prevalence of MT users within headache-clinic populations and a history of more medical appointments. This may also have implications for future MT trial designs both in terms of the selection of trial subjects from inside versus outside MT clinical settings and the decision to test singular MT interventions versus MT in combination with other interventions.

 

Limited information suggests that a pluralistic approach toward the use of medical and non-medical headache treatments such as MT is common. While findings suggest MT is sought most often for reasons of seeking headache relief, the evidence to support the efficacy of MT for headache relief is still limited. MT providers must remain mindful of the quality of the evidence for a given intervention for a given headache disorder and to inform patients where more effective or safer treatment interventions are available. More research is needed to assess these therapies individually and through multimodal approaches and for studies to include long-term follow-up.

 

Information limited to Italy, suggests referral from GPs for MT headache treatment can be common in some regions, while this is less likely to widespread given the issue of patient non-disclosure to medical doctors regarding the use of this treatment in other studies. High quality healthcare requires open and transparent communication between patients and providers and between the providers themselves. Non-disclosure may adversely influence medical management should unresponsive patients require further diagnostic investigations [80] or the implementation of more effective approaches to headache management [81] or prevents discussion in circumstances where MT may be contraindicated [82]. Primary headache providers may benefit from paying particular attention to the possibility of non-disclosure of non-medical headache treatments. Open discussion between providers and patients about the use of MT for headache and the associated outcomes may improve overall patient care.

 

Future Research

 

Despite the strong need for more high quality research to assess the efficacy of MT as a treatment for headache, the substantial use of MT brings attention to the need for more public health and health services research within this area of headache management. The need for this type of research was identified in a recent global report on the use of headache-related healthcare resources [18]. Furthering this information can lead to improvements in healthcare policy and the delivery of healthcare services.

 

The substantial use of physical therapies such as MT has been under-reported within many of the national surveys reporting headache-related healthcare utilization [3, 5, 83�85]. Regardless, the role of physical therapies in headache management continues to be assessed, often within mainstream and integrated headache management settings [86�89]. Continuing this research may further our understanding of the efficacy and outcomes associated with a more multidisciplinary approach to headache management.

 

Further to this is the need for more research to understand the healthcare utilization pathways associated with those patients who use MT in their headache management. Little is known about the sociodemographic background, types of headaches, level of headache disability and comorbidities more common to this patient population. In turn, such information can provide insights that may be valuable to provider clinical decision-making and provider education.

 

Limitations

 

The design and findings of our review has a number of limitations. The design of the review was limited by a search within English language journals only. As a result, some research on this topic may have been missed. While the quality scoring system adopted for this review requires further validation, the data we collected was limited by the low to moderate quality of available papers which averaged 6.4 out of 10 points (Table 3). The low scoring was largely due to significant methodological issues and the small sample size associated with much of the collected papers. Much of the data on this topic was heterogeneous in nature (telephone, postal surveys and face-to-face interviews). There was a lack of validated practitioner and patient questionnaires to report findings, such as for questions on prevalence, where the time frames utilized varied between �currently�, �last 12 months� and �ever�.

 

Data on the prevalence of MT use for headache was limited particularly within individual MT provider populations when compared to data found within the general population and headache-clinic populations. Many studies assessed the use of MT for headache without identifying headache types. Only one study inside an MT population had reported the percentage of patients attending for reasons of migraine alone (osteopathy). The prevalence of MT use for headache was reported most within chiropractic patient population studies, however information was limited on the types of headache. We found no studies reporting the prevalence of headache patients within physiotherapy or massage therapy patient populations using our search terms.

 

A lack of data for some themes necessitated providing findings pooled with users of other non-medical headache providers. Data within many geographical regions was very limited with the most limited data was on the source of referral to MT headache providers (three papers from Italy only). These limitations support the call for more research to be focused exclusively within MT populations and different regional areas before stronger conclusions can be drawn.

 

Conclusion

 

The needs of those with headache disorders can be complex and multi-disciplinary in nature. Beyond clinical research, more high quality public health and health services research is needed to measure and examine a number of issues of significance to the delivery and use of MT�s within headache management. With unmet needs still remaining for many who suffer recurrent headaches, clinicians should remain cognizant of the use of MT�s and remain open to discussing this approach to headache management in order to ensure greater safety, effectiveness and coordination of headache care.

 

Acknowledgements

 

Not applicable.

 

Funding

 

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors while the first author on this paper receives a PhD scholarship made available by the Australian Chiropractors� Association.

 

Availability of Data and Materials

 

Not applicable (all data is reported in article).

 

Authors’ Contributions

 

CM, JA and DS designed the paper. CM carried out the literature search, data collection and selection. CM and DS provided the analysis and interpretation. CM and JA wrote the drafts. All authors contributed to the critical review and intellectual content. All authors read and approved the final manuscript.

 

Competing Interests

 

The authors declare that they have no competing interests.

 

Consent for Publication

 

Not applicable.

 

Ethics Approval and Consent to Participate

 

Not applicable.

 

Publisher�s Note

 

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

 

Abbreviations

 

  • MT Manual therapy
  • EMG Electromyography

 

Contributor Information

 

Ncbi.nlm.nih.gov/pmc/articles/PMC5364599/

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

A staggering 15% of the population suffers from migraines, a debilitating condition which affects an individual’s ability to engage in everyday activities. Although widely misunderstood by researches today, I believe that migraine pain can be a symptom of a much bigger underlying health issue. Lumbar herniated discs, or ruptured discs in the lumbar spine, are a common cause of lower back pain and sciatica. When the soft, gel-like center of a lumbar herniated disc compresses the nerve roots of the low back, it can result in symptoms of pain and discomfort, numbness and weakness in the lower extremities. What’s more, a lumbar herniated disc can unbalance the structure and function of the entire spine, eliciting symptoms along the cervical spine that could ultimately trigger migraines. People who constantly experience migraine pain often have to carefully go about their day in hopes of avoiding the blaze of another painful episode. Fortunately, many migraine pain and lumbar herniated disc treatment methods are available to help improve as well as manage the symptoms. Other treatment options can also be considered before surgical interventions.

 

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

 

Abstract

 

Study Design

 

Concurrent prospective randomized and observational cohort studies.

 

Objective

 

To assess the 8-year outcomes of surgery vs. non-operative care.

 

Summary of Background Data

 

Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial.

 

Methods

 

Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI – AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter.

 

Results

 

Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (?36.2 vs. ?24.8; ?11.2; ?13.6 to ?9.1).

 

Conclusion

 

Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years.

 

Keywords: SPORT, intervertebral disc herniation, surgery, non-operative care, outcomes

 

Introduction

 

Lumbar discectomy for relief of sciatica in patients with intervertebral disc herniation (IDH) is a well-researched and common indication for spine surgery, yet rates of this surgery exhibit considerable geographic variation.[1] Several randomized trials and large prospective cohorts have demonstrated that surgery provides faster pain relief and perceived recovery in patients with herniated disc.[2�6] The effect of surgery on longer term outcomes remains less clear.

 

In a classic RCT evaluating surgery versus non-operative treatment for lumbar IDH, Weber et al. showed a greater improvement in the surgery group at 1 year that was statistically significant; there was also greater improvement for surgery at 4 years, although not statistically significant, but no apparent difference in outcomes at 10 years.[2] However, a number of patients in the non-operative group eventually underwent surgery over that time, complicating the interpretation of the long-term results. The Maine Lumbar Spine Study, a prospective observational cohort, found greater improvement at one year in the surgery group that narrowed over time, but remained significantly greater in the surgical group for sciatica bothersomeness, physical function, and satisfaction, but no different for work or disability outcomes.[3] This paper reports 8-year results from the Spine Patient Outcomes Research Trial (SPORT) based on the continued follow-up of the herniated disc randomized and observational cohorts.

 

Methods

 

Study Design

 

SPORT is a randomized trial with a concurrent observation cohort conducted in 11 US states at 13 medical centers with multidisciplinary spine practices. The human subjects committees at each participating institution approved a standardized protocol for both the observational and the randomized cohorts. Patient inclusion and exclusion criteria, study interventions, outcome measures, and follow-up procedures have been reported previously.[5�8]

 

Patient Population

 

Men and women were eligible if they had symptoms and confirmatory signs of lumbar radiculopathy persisting for at least six weeks, disc herniation at a corresponding level and side on imaging, and were considered surgical candidates. The content of pre-enrollment non-operative care was not pre-specified in the protocol.[5�7] Specific enrollment and exclusion criteria are reported elsewhere.[6,7]

 

A research nurse at each site identified potential participants, verified eligibility and used a shared decision making video for uniformity of enrollment. Participants were offered enrollment in either the randomized trial or the observational cohort. Enrollment began in March of 2000 and ended in November of 2004.

 

Study Interventions

 

The surgery was a standard open discectomy with examination of the involved nerve root.[7,9] The non-operative protocol was �usual care� recommended to include at least: active physical therapy, education/counseling with home exercise instruction, and non-steroidal anti-inflammatory drugs if tolerated. Non-operative treatments were individualized for each patient and tracked prospectively.[5�8]

 

Study Measures

 

Primary endpoints were the Bodily Pain (BP) and Physical Function (PF) scales of the SF-36 Health Survey[10] and the AAOS/Modems version of the Oswestry Disability Index (ODI)[11] as measured at 6 weeks, 3 and 6 months, and annually thereafter. If surgery was delayed beyond six weeks, additional follow-up data was obtained 6 weeks and 3 months post-operatively. Secondary outcomes included patient self-reported improvement; work status; satisfaction with current symptoms and care;[12] and sciatica severity as measured by the sciatica bothersomeness index.[13,14] Treatment effect was defined as the difference in the mean changes from baseline between the surgical and non-operative groups.

 

Statistical Considerations

 

Initial analyses compared means and proportions for baseline patient characteristics between the randomized and observational cohorts and between the initial treatment arms of the individual and combined cohorts. The extent of missing data and the percentage of patients undergoing surgery were calculated by treatment arm for each scheduled follow-up. Baseline predictors of time until surgical treatment (including treatment crossovers) in both cohorts were determined via a stepwise proportional hazards regression model with an inclusion criterion of p < 0.1 to enter and p > 0.05 to exit. Predictors of missing follow-up visits at yearly intervals up to 8 years were separately determined via stepwise logistic regression. Baseline characteristics that predicted surgery or a missed visit at any time-point were then entered into longitudinal models of primary outcomes. Those that remained significant in the longitudinal models of outcome were included as adjusting covariates in all subsequent longitudinal regression models to adjust for potential confounding due to treatment selection bias and missing data patterns.[15] In addition, baseline outcome, center, age and gender were included in all longitudinal outcome models.

 

Primary analyses compared surgical and non-operative treatments using changes from baseline at each follow-up, with a mixed effects longitudinal regression model including a random individual effect to account for correlation between repeated measurements within individuals. The randomized cohort was initially analyzed on an intent-to-treat basis.[6] Because of cross-over, additional analyses were performed based on treatments actually received. In these as-treated analyses, the treatment indicator was a time-varying covariate, allowing for variable times of surgery. Follow-up times were measured from enrollment for the intent-to-treat analyses, whereas for the as-treated analysis the follow-up times were measured from the beginning of treatment (i.e. the time of surgery for the surgical group and the time of enrollment for the non-operative group), and baseline covariates were updated to the follow-up immediately preceding the time of surgery. This procedure has the effect of including all changes from baseline prior to surgery in the estimates of the non-operative treatment effect and all changes after surgery in the estimates of the surgical effect. The six-point sciatica scales and binary outcomes were analyzed via longitudinal models based on generalized estimating equations[16] with linear and logit link functions respectively, using the same intent-to-treat and adjusted as-treated analysis definitions as the primary outcomes. The randomized and observational cohorts were each analyzed to produce separate as-treated estimates of treatment effect. These results were compared using a Wald test to simultaneously test all follow-up visit times for differences in estimated treatment effects between the two cohorts.[15] Final analyses combined the cohorts.

 

To evaluate the two treatment arms across all time-periods, the time-weighted average of the outcomes (area under the curve) for each treatment group was computed using the estimates at each time period from the longitudinal regression models and compared using a Wald test.[15]

 

Kaplan-Meier estimates of re-operation rates at 8 years were computed for the randomized and observational cohorts and compared via the log-rank test.[17,18]

 

Computations were done using SAS procedures PROC MIXED for continuous data and PROC GENMOD for binary and non-normal secondary outcomes (SAS version 9.1 Windows XP Pro, Cary, NC). Statistical significance was defined as p < 0.05 based on a two-sided hypothesis test with no adjustments made for multiple comparisons. Data for these analyses were collected through February 4, 2013.

 

Results

 

Overall, 1,244 SPORT participants with lumbar intervertebral disc herniation were enrolled (501 in the randomized cohort, and 743 in the observational cohort) (Figure 1). In the randomized cohort, 245 were assigned to surgical treatment and 256 to non-operative treatment. Of those randomized to surgery, 57% had surgery by 1 year and 60% by 8 years. In the group randomized to non-operative care, 41% of patients had surgery by 1 year and 48% by 8 years. In the observational cohort, 521 patients initially chose surgery and 222 patients initially chose non-operative care. Of those initially choosing surgery, 95% received surgery by 1 year; at 8 years 12 additional patients had undergone primary surgery. Of those choosing non-operative treatment, 20% had surgery by 1 year and 25% by 8 years. In both cohorts combined, 820 patients received surgery at some point during the first 8 years; 424 (34%) remained non-operative. Over the 8 years, 1,192 (96%) of the original enrollees completed at least 1 follow-up visit and were included in the analysis (randomized cohort: 94% and observational cohort 97%); 63% of initial enrollees supplied data at 8 years with losses due to dropouts, missed visits, or deaths (Figure 1).

 

Figure-1-Exclusion-Enrollment-Randomization-and-Follow-Up

Figure 1: Exclusion, enrollment, randomization and follow-up of trial participants.

 

Patient Characteristics

 

Baseline characteristics have been previously reported and are summarized in Table 1.[5,6,8] The combined cohorts had an overall mean age of 41.7 with slightly more men than women. Overall, the randomized and observational cohorts were similar. However, patients in the observational cohort had more baseline disability (higher ODI scores), were more likely to prefer surgery, more often rated their problem as worsening, and were slightly more likely to have a sensory deficit. Subjects receiving surgery over the course of the study were: younger; less likely to be working; more likely to report being on worker�s compensation; had more severe baseline pain and functional limitations; fewer joint and other co-morbidities; greater dissatisfaction with their symptoms; more often rated their condition as getting worse at enrollment; and were more likely to prefer surgery. Subjects receiving surgery were also more likely to have a positive straight leg test, as well as more frequent neurologic, sensory, and motor deficits. Radiographically, their herniations were more likely to be at the L4�5 and L5-S1 levels and to be posterolateral in location.

 

Table 1 Patient Baseline Demographic Characteristics, Comorbidities and Health Status Measures

Table 1: Patient baseline demographic characteristics, comorbidities and health status measures according to study cohort and treatment received.

 

Surgical Treatment and Complications

 

Overall surgical treatment and complications were similar between the two cohorts (Table 2). The average surgical time was slightly longer in the randomized cohort (80.5 minutes randomized vs. 74.9 minutes observational, p=0.049). The average blood loss was 75.3cc in the randomized cohort vs. 63.2cc in the observational, p=0.13. Only 6 patients total required intra-operative transfusions. There were no perioperative mortalities. The most common surgical complication was dural tear (combined 3% of cases). Re-operation occurred in a combined 11% of cases by 5 years, 12% by 6 years, 14% by 7 years, and 15% by 8 years post-surgery. The rates of reoperation were not significantly different between the randomized and observational cohorts. Eighty-seven of the 119 re-operations noted the type of re-operation; approximately 85% of these (74/87) were listed as recurrent herniations at the same level. One death occurred within 90 days post-surgery related to heart surgery at another institution; the death was judged to be unrelated and was reported to the Institutional Review Board and the Data and Safety Monitoring Board.

 

Table 2 Operative Treatments, Complications and Events

Cross-Over

 

Non-adherence to treatment assignment affected both treatment arms: patients chose to delay or decline surgery in the surgical arm and crossed over to surgery in the non-operative arm. (Figure 1) Statistically significant differences of patients crossing over to non-operative care within 8 years of enrollment were that they were older, had higher incomes, less dissatisfaction with their symptoms, more likely to have a disc herniation at an upper lumbar level, more likely to express a baseline preference for non-operative care, less likely to perceive their symptoms as getting worse at baseline, and had less baseline pain and disability (Table 3). Patients crossing over to surgery within 8 years were more dissatisfied with their symptoms at baseline; were more likely to perceive they were getting worse at baseline; more likely to express a baseline preference for surgery; and had worse baseline physical function and more self-rated disability.

 

Table 3 Statistically Significant Predictors of Adherence to Treatment

Table 3: Statistically significant predictors of adherence to treatment among RCT patients.

 

Main Treatment Effects

 

Intent-to-Treat Analysis In the intention-to-treat analysis of the randomized cohort, all measures over 8 years favored surgery but there were no statistically significant treatment effects in the primary outcome measures (Table 4 and Figure 2). In the overall intention-to-treat comparison between the two treatment groups over time (area-under the curve), secondary outcomes were significantly greater with surgery in the intention-to-treat analysis (sciatica bothersomeness (p=0.005), satisfaction with symptoms (p=0.013), and self-rated improvement (p=0.013)) (Figure 3) Improvement in sciatica bothersomeness index was also statistically significant in favor of surgery at most individual time point comparisons (although non-significant in years 6 and 7) (Table 4).

 

Figure-2-Primary-Outcomes-in-the-Randomized-and-Observational-Cohorts

Figure 2: Primary outcomes (SF-36 Bodily Pain and Physical Function, and Oswestry Disability Index) in the randomized and observational cohorts during 8 years of follow-up.

 

Figure-3-Secondary-Outcomes-in-the-Randomized-and-Observational-Cohorts.

Figure 3: secondary outcomes (Sciatica Bothersomeness, Satisfaction with Symptoms, and Self-rated Global Improvement) in the randomized and observational cohorts during 8 years of follow-up.

 

Table 4 Primary Analysis Results for Years 1 to 8

Table 4: Primary analysis results for years 1 to 8. Intent-to-treat for the randomized cohort and adjusted* analyses according to treatment received for the randomized and observational cohorts combined.

 

As-Treated Analysis The adjusted as-treated effects seen in the randomized and observational were similar. Accordingly, the cohorts were combined for the final analyses. Treatment effects for the primary outcomes in the combined as-treated analysis were clinically meaningful and statistically significant out to 8 years: SF-36 BP 10.9 p < 0.001 (95% CI 7.7 to 14); SF-36 PF 10.6 p<0.001 (95% CI 7.7 to 13.5); ODI ?11.3 p<0.001 (95% CI ?13.6 to ?9.1) (Table 4). The footnote for Table 4 describes the adjusting covariates selected for the final model.

 

Results from the intent-to-treat and as-treated analyses of the two cohorts are compared in Figure 2. In the combined analysis, treatment effects were statistically significant in favor of surgery for all primary and secondary outcome measures (with the exception of work status which did not differ between treatment groups) at each time point (Table 4 and Figure 3).

 

Loss-to-Follow-Up

 

At the 8-year follow-up, 63% of initial enrollees supplied data, with losses due to dropouts, missed visits, or deaths. Table 5 summarized the baseline characteristics of those lost to follow-up compared to those retained in the study at 8-years. Those who remained in the study at 8 years were – somewhat older; more likely to be female, white, college educated, and working at baseline; less likely to be disabled, receiving compensation, or a smoker; less symptomatic at baseline with somewhat less bodily pain, better physical function, less disability on the ODI, better mental health, and less sciatica bothersomeness. These differences were small but statistically significant. Table 6 summarizes the short-term outcomes during the first 2 years for those retained in the study at 8 years compared to those lost to follow-up. Those lost to follow-up had worse outcomes on average; however this was true in both the surgical and non-operative groups with non-significant differences in treatment effects. The long-term outcomes are therefore likely to be somewhat over-optimistic on average in both groups, but the comparison between surgical and non-operative outcomes appear likely to be un-biased despite the long-term loss to follow-up.

 

Table 5 Patient Baseline Demographic Characteristics, Comorbidities and Health Status Measures

Table 5: Patient baseline demographic characteristics, comorbidities, and health status measures according to patient follow-up status as of 02/01/2013 when the IDH8yr data were pulled.

 

Table 6 Time Weighted Average of Treatment Effects

Table 6: Time-weighted average of treatment effects at 2 years (AUC) from adjusted* as-treated randomized and observational cohorts combined primary outcome analysis, according to treatment received and patient follow-up status.

 

Discussion

 

In patients with a herniated disc confirmed by imaging and leg symptoms persisting for at least 6 weeks, surgery was superior to non-operative treatment in relieving symptoms and improving function. In the as-treated analysis, the treatment effect for surgery was seen as early as 6 weeks, appeared to reach a maximum by 6 months and persisted over 8 years; it is notable that the non-operative group also improved significantly and this improvement persisted with little to no degradation of outcomes in either group (operative and non-operative) between 4 and 8 years. In the longitudinal intention-to-treat analysis, all the outcomes showed small advantages for surgery, but only the secondary outcomes of sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement were statistically significant. The persistent small benefit in the surgery group over time has made the overall intention-to-treat comparison more statistically significant over time despite high levels of cross-over. The large effects seen in the as-treated analysis after adjustments for characteristics of the crossover patients suggest that the intent-to-treat analysis may underestimate the true effect of surgery since the mixing of treatments due to crossover can be expected to create a bias toward the null in the intent-to-treat analyses.[4,19] Loss to follow-up among patients who were somewhat worse at baseline and with worse short-term outcomes probably leads to overly-optimistic estimated long-term outcomes in both surgery and non-operative groups but unbiased estimates of surgical treatment effects.

 

Comparisons to Other Studies

 

There are no other long-term randomized studies reporting the same primary outcome measures as SPORT. The results of SPORT primary outcomes at 2 years were quite similar to those of Peul et al but longer follow up for the Peul study is necessary for further comparison.[4,20] In contrast to the Weber study, the differences in the outcomes in SPORT between treatment groups remained relatively constant between 1 and 8 years of follow-up. One of the factors in this difference may be the sensitivity of the outcome measures � for example, sciatica bothersomeness, which was significantly different out to 8 years in the intention-to-treat, may be a more sensitive marker of treatment success than the general outcome measure used by Weber et al.[2]

 

The long-term results of SPORT are similar to the Maine Lumbar Spine Study (MLSS).[21] The MLSS reported statistically significantly greater improvements at 10 years in sciatica bothersomeness for the surgery group (?11.9) compared to the nonsurgical groups (?5.8) with a treatment effect of ?6.1 p=0.004; in SPORT the improvement in sciatica bothersomeness in the surgical group at 8 years was similar to the 10 year result in MLSS (?11) though the non-operative cohort in SPORT did better than their MLSS counterparts (?9.1) however the treatment effect in SPORT, while smaller, remained statistically significant (?1.5; p<0.001) due to the much larger sample size. Greater improvements in the non-operative cohorts between SPORT and MLSS may be related to differences in non-operative treatments over time, differences between the two cohorts since the MLSS and did not require imaging confirmation of IDH.

 

Over the 8 years there was little evidence of harm from either treatment. The 8-year rate of re-operation was 14.7%, which is lower than the 25% reported by MLSS at 10 years.[22]

 

Limitations

 

Although our results are adjusted for characteristics of cross over patients and control for important baseline covariates, the as-treated analyses presented do not share the strong protection from confounding that exists for an intent-to-treat analysis.[4�6] However, However, intent-to-treat analyses are known to be biased in the presence of noncompliance at the level observed in SPORT, and our adjusted as-treated analyses have been shown to produce accurate results under reasonable assumptions about the dependence of compliance on longitudinal outcomes.[23] Another potential limitation is the heterogeneity, of the non-operative treatment interventions, as discussed in our prior papers.[5,6,8] Finally, attrition in this long-term follow-up study meant that only 63% of initial enrollees supplied data at 8 years with losses due to dropouts, missed visits, or deaths; based on analyses at baseline and at short-term follow-up, this likely leads to somewhat overly-optimistic estimated long-term outcomes in both treatment groups but an unbiased estimation of surgical treatment effect.

 

Conclusions

 

In the intention-to-treat analysis, small, statistically insignificant surgical treatment effects were seen for the primary outcomes but statistically significant advantages for sciatica bothersomeness, satisfaction with symptoms, and self-rated improvement were seen out to 8 years despite high levels of treatment cross-over. The as-treated analysis combining the randomized and observational cohorts, which carefully controlled for potentially confounding baseline factors, showed significantly greater improvement in pain, function, satisfaction, and self-rated progress over 8 years compared to patients treated non-operatively. The non-operative group, however, also showed substantial improvements over time, with 54% reporting being satisfied with their symptoms and 73% satisfied with their care after 8 years.

 

Acknowledgments

 

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01-AR45444; P60-AR062799) and the Office of Research on Women�s Health, the National Institutes of Health, and the National Institute of Occupational Safety and Health, the Centers for Disease Control and Prevention grant funds were received in support of this work. Relevant financial activities outside the submitted work: consultancy, grants, stocks.

 

This study is dedicated to the memories of Brieanna Weinstein and Harry Herkowitz, leaders in their own rights, who simply made the world a better place.

 

Footnotes

 

Other comorbidities include: stroke, diabetes, osteoporosis, cancer, fibromyalgia, cfs, PTSD, alcohol, drug dependency, heart, lung, liver, kidney, blood vessel, nervous system, hypertension, migraine, anxiety, stomach, bowel

 

In conclusion, individuals who suffer from migraine pain require the most effective type of treatment in order to help improve as well as manage their symptoms, particularly if their migraines were elicited from a lumbar herniated disc. The purpose of the following articles was to associate the two conditions with each other and demonstrate the results of the research above. Various treatment options can be considered before surgery for migraine pain and lumbar herniated disc treatment. 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

 

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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!

 

OTHER IMPORTANT TOPICS: EXTRA: Sports Injuries? | Vincent Garcia | Patient | El Paso, TX Chiropractor

 

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Migraine and Cervical Disc Herniation Treatment In El Paso, TX Chiropractor

Migraine and Cervical Disc Herniation Treatment In El Paso, TX Chiropractor

by | Herniated Disc, Migraine, Physical Rehabilitation, Randomized Controlled Trial, Treatments

Migraine is a debilitating condition characterized by a headache of varying intensity, often accompanied by nausea and sensitivity to light and sound. While researchers today still don’t understand the true reason behind this primary headache disorder, many healthcare professionals believe a misalignment of the cervical spine can lead to migraine. However, new evidence-based research studies have determined that cervical disc herniation, a health issue associated with the intervertebral discs of the upper spine, may also cause head pain. The purpose of the following article is to educate patients and help them understand the source of their symptoms as well as to demonstrate several types of treatment effective for migraine and cervical disc herniation.

 

Manual Therapies for Primary Chronic Headaches: a Systematic Review of Randomized Controlled Trials

 

Abstract

 

This is to our knowledge the first systematic review regarding the efficacy of manual therapy randomized clinical trials (RCT) for primary chronic headaches. A comprehensive English literature search on CINHAL, Cochrane, Medline, Ovid and PubMed identified 6 RCTs all investigating chronic tension-type headache (CTTH). One study applied massage therapy and five studies applied physiotherapy. Four studies were considered to be of good methodological quality by the PEDro scale. All studies were pragmatic or used no treatment as a control group, and only two studies avoided co-intervention, which may lead to possible bias and makes interpretation of the results more difficult. The RCTs suggest that massage and physiotherapy are effective treatment options in the management of CTTH. One of the RCTs showed that physiotherapy reduced headache frequency and intensity statistical significant better than usual care by the general practitioner. The efficacy of physiotherapy at post-treatment and at 6 months follow-up equals the efficacy of tricyclic antidepressants. Effect size of physiotherapy was up to 0.62. Future manual therapy RCTs are requested addressing the efficacy in chronic migraine with and without medication overuse. Future RCTs on headache should adhere to the International Headache Society�s guidelines for clinical trials, i.e. frequency as primary end-point, while duration and intensity should be secondary end-point, avoid co-intervention, includes sufficient sample size and follow-up period for at least 6 months.

 

Keywords: Randomized clinical trials, Primary chronic headache, Manual therapies, Massage, Physiotherapy, Chiropractic

 

Introduction

 

Primary chronic headaches i.e. chronic migraine (CM), chronic tension-type headache (CTTH) and chronic cluster headache has significant health, economic and social costs. About 3% of the general population suffers from chronic headache with female predominance [1]. The International Classification of Headache Disorders III ? (ICDH-III ?) defines CM as ?15 headache days/month for at least 3 months with features of migraine in ?8 days/month, CTTH is defined as on average ?15 days/month with tension-type headache for at least 3 months, and chronic cluster headache as attacks at least every other day for more than 1 year without remission, or with remissions lasting <1 month [2].

 

About 80% consult their primary physician for primary chronic headache [3], and pharmacological management is considered first line of treatment. However, the risk is that it may cause overuse of acute headache medication due to frequent headache attacks. 47% of those with primary chronic headache in the general Norwegian population overused acute headache medication [1,4]. Considering the high use of acute medication, both prophylactic medication and non-pharmacological management should therefore be considered in the management [5,6]. Prophylactic medication is used only by 3% in the general Norwegian population, while 52% have tried physiotherapy and 28% have tried chiropractic spinal manipulative therapy [3]. Non-pharmacological management has furthermore the advantage of few and usually minor transient adverse events and no pharmacological interaction/adverse event [7].

 

Previous systematic reviews have focused on RCTs for tension-type headache, migraine and/or cervicogenic headache, but not on efficacy on primary chronic headache [5,6,8-11]. Manual therapy is a physical treatment used by physiotherapists, chiropractors, osteopaths and other practitioners to treat musculoskeletal pain and disability, and includes massage therapy, joint mobilization and manipulation [12].

 

This is to our knowledge the first systematic review assessing the efficacy of manual therapy randomized controlled trials (RCT) for primary chronic headache using headache frequency as primary end-point and headache duration and intensity as secondary end-points.

 

Review

 

Methods

 

The English literature search was done on CINHAL, Cochrane, Medline, Ovid and PubMed. Search words were; migraine, chronic migraine, tension-type headache, chronic tension-type headache, cluster headache, chronic cluster headache combined with the words; massage therapy, physiotherapy, spinal mobilization, manipulative therapy, spinal manipulative therapy, osteopathic treatment or chiropractic. We identified studies by a comprehensive computerized search. Relevant reviews were screened for additional relevant RCTs. The selection of articles was performed by the authors. All RCTs written in English using either of the manual therapies for CM, CTTH and/or chronic cluster headache were evaluated. Studies including combined headache types without specific results for CM, CTTH and/or chronic cluster headache were excluded. The review included manual therapy RCTs presenting at least one of the following efficacy parameters; headache frequency, duration and pain intensity for CM, CTTH and/or chronic cluster headache as recommended by the International Headache Society�s clinical trial guidelines [13,14]. Headache frequency is a primary end-point, while duration and pain intensity are secondary end-points. Headache diagnoses were preferentially classified according to the criteria of ICHD-III ? or previous editions [2,15-17]. The methodological quality of the included RCTs was evaluated using the PEDro scale, Table 1[18]. A RCT was considered to be of high quality if the PEDro score was ?6 of a maximum score of 10. The methodological quality of the RCTs was assessed by AC. The PRISMA 2009 checklist was applied for this systematic review. Effect size was calculated when possible. Effect size of 0.2 was regarded as small, 0.5 as medium and 0.8 as large [19].

 

Table-1-PEDro-Score-Yes-or-No-Items.png

Table 1: PEDro score yes or no items.

 

This systematic review was executed directly based on the ascertained RCTs available and has not been registered as a review protocol.

 

Results

 

The literature search identified six RCTs that met our inclusion criteria. One study applied massage therapy (MT) and five studies applied physiotherapy (PT) [20-25]. All studies assessed CTTH, while no studies assessed CM or chronic cluster headache.

 

Methodological quality Table 2 shows that the methodological PEDro score of the included RCTs ranged from 1 to 8 points. Four RCTs were considered of good methodological quality, while two RCTs had lower scores.

 

Table 2 The Methodological PEDro Score of the Included RCTs

Table 2: The methodological PEDro score of the included randomized controlled trials (RCTs).

 

Randomized controlled trials (RCT) Table 3 shows the study population, intervention and efficacy of the six RCTs.

 

Table 3 Results of Manual Therapy RCTs of CTTH

Table 3: Results of manual therapy randomized controlled trials (RCTs) of chronic tension-type headache (CTTH).

 

Massage therapy A Spanish physiotherapist conducted a 2-armed prospective crossover RCT with pairwise comparisons and blinded outcome measures [20]. The study included participants with CTTH diagnosed by a neurologist. The ICHD-II criteria for CTTH were slightly modified, i.e. pain intensity was defined as ?5 on a 0-10 numeric pain rating scale, and the accompanying symptoms photophobia, phonophobia or mild nausea was not allowed [16]. Primary and secondary end-points were not specified. Results are shown in Table 3.

 

Physiotherapy An American 3-armed retrospectively RCT had unblinded outcome measures [21]. The diagnostic criteria were ?25 headache days/month for >6 months without associated symptoms nausea, vomiting, photo- and phonophobia, but with tender muscles, i.e. CTTH with pericranial tenderness. Participants with cervicogenic headache or neurological findings were excluded. Primary and secondary end-points were not pre-specified, but headache index, defined here as headache frequency � severity, was the evaluated end-point.

 

A Turkish study conducted a 2-armed prospective RCT with unblinded outcome measures [22]. The participants were diagnosed with CTTH according to ICHD-I [15]. Participants with mixed headache, neurological and systemic aliment, or participants whom had received physiotherapy within 6 months prior to the study were excluded. Primary end-points was headache index defined as frequency � severity.

 

A Danish study conducted a 2-armed prospective RCT with blinded outcome measures [23]. Participants were diagnosed CTTH by a neurologist according to the criteria of ICHD-I [15]. Participants with other primary headaches, neuralgia, neurological, systemic or psychiatric disorders or medication overuse defined as >100 analgesic tablets or >2 doses of triptans and ergotamine per month were excluded. The primary end-point was headache frequency, and the secondary end-points were headache duration and intensity. The results shown in Table 3 were not influenced by pericranial muscles tenderness.

 

A Dutch study conducted a 2-armed prospective, multicentre RCT with blinded outcome measures [24]. Participants were diagnosed with CTTH by a physician according to ICHD-I [15]. Participants with multiple headache types or those whom had received physiotherapy within the last 6 months were excluded. Primary end-points were headache frequency while duration and intensity were secondary end-points.

 

The 2nd Dutch study conducted a 2-armed prospective pragmatic, multicentre RCT with self-reported primary and secondary end-points, i.e. headache frequency, duration and intensity [25]. Participants were diagnosed by a physician according to the criteria of ICHD-II [16]. Participants with rheumatoid arthritis, suspected malignancy, pregnancy, non-Dutch speaking, those whom had received physiotherapy within the last 2 months, triptan, ergotamine or opiods users were excluded.

 

Discussion

 

The current systematic review evaluating the efficacy of manual therapy in RCTs for primary chronic headaches only identified RCTs treating CTTH. Thus, the efficacy of CM and chronic cluster headache could not be evaluated in this review.

 

Methodological considerations The methodological quality of studies assessing manual therapies for headache disorders are frequently being criticised for being too low. Occasionally rightly so, but often do the methodological design prevent manual therapy studies from reaching what is considered gold standard in pharmacological RCTs. For instance, a placebo treatment is difficult to establish while the investigator cannot be blinded for its applied intervention. The average score of the included studies was 5.8 (SD 2.6) points and four studies were considered of good quality. All RCTs failed to include sample size ?50 in the smallest group. Sufficient sample size with power calculation prior is important to confine type 2 errors. Three studies did not state primary and secondary end-points, which confound effect-size calculation, and risk of type 2 errors inferred from multiple measures [20-22]. Conducting a manual therapy RCT is both time and cost consuming, while blinding often is difficult as there is no single validated standardized sham-treatment which can be used as a control group to this date. Thus, all of the included studies were pragmatic or used no treatment as a control group.

 

Apart from the participants in the retrospective study [21], all participants were diagnosed by a physician or neurologist. A diagnostic interview is the gold standard, while questionnaire and lay interviews are less precise diagnostic tools regarding headache disorders [26].

 

Co-intervention was only avoided in two studies [22,20]. Two studies performed intention-to-treat analysis which is recommended to protect against odd outcome values and preserve baseline comparability [24,25,27].

 

Results The massage therapy study included only 11 participants, but the massage group had significantly more reduction in their headache intensity than detuned ultrasound group [20].

 

54%, 82% and 85% of the participants in three of the physiotherapy RCTs had a ?50% reduction in headache frequency post-treatment [23-25], and the effect was maintained in the two studies that had a 6 months follow-up [24,25]. This is comparable with the 40-70% of participants whom have a similar effect using tricyclic antidepressants [28,29]. The effect of tricyclic also seems to improve over time, i.e. after more than 6 months treatment [29]. However, tricyclic antidepressants have a series of side effects in contrast to physiotherapy, while manual therapy requires more consultations. Two studies assessed headache index defined as headache frequency � intensity [21,22]. Both studies showed a significant improvement post-treatment and at 1 month and 6 months follow-up respectively.

 

Four of the studies reported 10.1 mean years with headache, thus, the effect observed is likely to be due to the therapeutic effect rather than spontaneous improvement or regression to the mean [21-23,25].

 

Acute headache medication is frequently used for primary headaches, and if the headache frequency increases, there is an increased risk for medication overuse headache. Increased use of prophylactic medication has thus been suggested in the management for primary chronic headaches [3]. Since manual therapies seems to have a beneficial effect that equals the effect of prophylactic medication [28,29], without the pharmacological side effects, manual therapies should be considered on an equal level as pharmacological management strategies.

 

Effect size could be calculated in three of the six RCTs. Effect size on headache frequency was up to 0.62, while it was less regarding duration and intensity, while headache index (frequency � intensity) was up to 0.37 (Table 3). Thus, a small to moderate effect size might however, be substantial to the individual, especially considering that nearly daily headache i.e. mean 12/14 days reduced to mean 3/14 days [25], which equals ?75% reduction in headache frequency. Usually a ?50% reduction is traditionally used in pain trails, but considering the fact that CTTH is difficult to treat, some investigators operate with ?30% improvement of primary efficacy parameter compared with placebo [30].

 

Limitations The present study might have possible biases. One of them being publication bias as the authors made no attempt to identify unpublished RCTs. Although we did perform a comprehensive search, we acknowledge it is possible to miss a single or few RCT, especially non-English RCT.

 

Conclusion

 

Manual therapy has an efficacy in the management of CTTH that equals prophylactic medication with tricyclic antidepressant. At present no manual therapy studies exist for chronic migraine or chronic cluster headache. Future manual therapy RCTs on primary chronic headache should adhere to the recommendation of the International Headache Society, i.e. primary end point is headache frequency and secondary end-points are duration and intensity. Future manual therapy studies on CM with and without medication overuse is also warranted, since such studies do not exist today.

 

Competing Interests

 

The authors declare that they have no competing interests.

 

Authors� Contributions

 

AC prepared the initial draft and performed the methodological assessment of the included studies. MBR had the original idea of the study, planned the overall design and revised the drafted manuscript. Both authors have read and approved the final manuscript.

 

Authors� Information

 

Aleksander Chaibi is a BPT, MChiro, PhD student and Michael Bj�rn Russell is a professor, MD, PhD, DrMedSci.

 

Acknowledgements

 

Akershus University Hospital, Norway, kindly provided research facilities.

 

Funding: The study received funding from Extrastiftelsen, the Norwegian Chiropractic Association in Norway and University of Oslo.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Cervical disc herniation is a common condition which occurs when an intervertebral disc in the neck, or cervical spine, ruptures and its soft, gel-like center leaks out into the spinal canal, adding pressure to the nerve roots. Cervical herniated discs can cause symptoms of pain, numbness and weakness in the neck, shoulders, chest, arms and hands as well as radiating symptoms along the lower extremities. Migraine can also be a symptoms associated with herniated discs in the neck. As we age, the intervertebral discs naturally begin to degenerate, making them more susceptible to damage or injury. Common causes of cervical disc herniation include wear and tear, repetitive movements, improper lifting, injury, obesity and genetics.

 

Long Term Follow-Up of Cervical Intervertebral Disc Herniation in Patients Treated with Integrated Complementary and Alternative Medicine: a Prospective Case Series Observational Study

 

Abstract

 

Background

 

Symptomatic cervical intervertebral disc herniation (IDH) presenting as neck pain accompanied by arm pain is a common affliction whose prevalence continues to rise, and is a frequent reason for integrative inpatient care using complementary and alternative medicine (CAM) in Korea. However, studies on its long term effects are scarce.

 

Methods

 

A total 165 patients with cervical IDH admitted between January 2011 and September 2014 to a hospital that provides conventional and Korean medicine integrative treatment with CAM as the main modality were observed in a prospective observational study. Patients underwent CAM treatment administered by Korean medicine doctors (KMDs) in accordance with a predetermined protocol for the length of hospital stay, and additional conventional treatment by medical doctors (MDs) as referred by KMDs. Short term outcomes were assessed at discharge and long term follow-ups were conducted through phone interviews after discharge. Numeric rating scale (NRS) of neck and radiating arm pain, neck disability index (NDI), 5-point patient global impression of change (PGIC), and factors influencing long term satisfaction rates in PGIC were assessed.

 

Results

 

Of 165 patients who received inpatient treatment 20.8?�?11.2 days, 117 completed the long term follow-up up at 625.36?�?196.7 days post-admission. Difference in NRS between admission and discharge in the long term follow-up group (n?=?117) was 2.71 (95 % CI, 2.33, 3.09) for neck pain, 2.33 (95 % CI, 1.9, 2.77) for arm pain, and that of NDI 14.6 (95 % CI, 11.89, 17.32), and corresponding scores in the non-long term follow-up group (n?=?48) were 2.83 (95 % CI, 2.22, 3.45) for neck pain, 2.48 (95 % CI, 1.84, 3.12) for arm pain, and that of NDI was 14.86 (95 % CI, 10.41, 19.3). Difference in long term NRS of neck pain and arm pain from baseline was 3.15 (95 % CI, 2.67, 3.64), and 2.64 (95 % CI, 1.99, 3.29), respectively. PGIC was reported to be �satisfactory� or higher in 79.5 % of patients at long term follow-up.

 

Conclusions

 

Though the observational nature of this study limits us from drawing a more decisive conclusion, these results suggest that integrative treatment focused on CAM in cervical IDH inpatients may achieve favorable results in pain and functional improvement.

 

Trial Registration

 

ClinicalTrials.gov Identifier: NCT02257723. Registered October 2, 2014.

 

Keywords: Cervical intervertebral disc herniation, Complementary and alternative medicine, Integrative treatment, Inpatient treatment

 

Background

 

Neck pain is a common compliant whose point prevalence is estimated at 10�18 %, with lifetime prevalence reaching 30�50 %. Prevalence of neck pain in populations aged 40 or older is approximately 20 % [1, 2]. Neck pain is also related with restricted neck movement [3], and frequently accompanied by headache, dizziness, visual impairment, tinnitus, and autonomic nervous system dysfunction [4, 5]. Frequent concurrent symptoms include upper extremity pain and neurological disorders [6], and neck pain symptoms also persist in many cases leading to work loss due to discomfort [7]. Neck-related disability is generally more serious in patients with radiating pain than pain limited to the neck area [8, 9], and the main characteristic of cervical intervertebral disc herniation (IDH) is arm pain in the region innervated at the herniated disc level and/or compressed nerve root [10, 11].

 

The range of available treatments for cervical IDH is vast, spanning conservative treatments to various surgical modalities. Conservative treatments include NSAIDs, oral steroids, steroid injections, patient education, rest, Thomas collars, and physical therapy [12�14]. Surgical treatment may be considered when conservative treatment fails. Neuropathy from spinal cord compression is an absolute indication for surgery. Other indications include nerve root compression signs and related motor and sensory loss. Relative indications may involve decreased quality of life due to prolonged chronic pain [15]. While surgical treatment may benefit some patients suffering severe neurological symptoms, most studies on neuropathic pain of the spine state that the long term effects are not significant [16�20]. Although studies on the effect of conservative treatment in cervical IDH patients have occasionally been reported, whether it is effective is yet a matter of controversy, and there is a paucity of studies on the effect of complementary and alternative medicine (CAM) treatment.

 

According to Benefits by Frequency of Disease data from the 2013 Korean National Health Insurance Statistical Yearbook [21], 5585 patients received treatment for cervical disc disorders for 99,582 days in outpatient care, of which 100,205 days were covered by the National Health Insurance, and medical treatment expenses eligible for reimbursement surmounted to 5,370,217 Korean Won, with 4,004,731 Korean Won reimbursed. Cervical disc disorders was the 12th most frequent reason for admission to Korean medicine hospitals, showing that it is not uncommon to receive inpatient care for cervical IDH.

 

Such CAM treatments as acupuncture, pharmacopuncture, herbal medicine, and manual therapy are well-sought in Korea to the aim of securing a less invasive, non-surgical method of treatment. Jaseng Hospital of Korean medicine, a Korean medicine hospital accredited by the Korean Ministry of Health and Welfare to specialize in spine disorders, treats over 900,000 spinal disease outpatient cases per year. This hospital manages patients with an integrative system utilizing conventional and Korean medicine, where conventional doctors and Korean medicine doctors (KMDs) cooperate for optimal treatment results. Conventional doctors participate in diagnosis using imaging technology such as X-rays and MRIs, and in treatment by caring for a small percentage of patients potentially in need of more intensive care. KMDs supervise and manage the main treatment of all patients, and decide whether the patient requires additional diagnosis and treatment from a conventional doctor. Cervical IDH patients suffering neck pain or radiating pain unable to receive outpatient treatment are thus provided with concentrated non-surgical integrative treatment during admission.

 

Despite the widespread use of inpatient treatment for cervical IDH encompassing a number of treatment modalities, studies on its treatment effect in patients admitted for cervical IDH are scarce. An integrative inpatient treatment approach with focus on CAM may not be widely available to patients, and the objective of this study is to introduce and assess the feasibility and long term effect of this integrative treatment model in inpatients with cervical IDH using a practical study design.

 

Methods

 

Study Design

 

This study is a prospective observational study. We observed patients with a main complaint of neck pain or radiating arm pain diagnosed as cervical IDH and admitted from January 2011 to September 2014 at Jaseng Hospital of Korean medicine in Korea which provides integrated conventional and Korean medicine services with CAM as the main modality. The authors conducted a long term follow-up by phone interview during March 2015. Outcome measures covered 5 parts: numeric rating scale (NRS), neck disability index (NDI), patient global impression of change (PGIC), ever-surgery after discharge, and current treatment.

 

This study is a report on part of a registry collecting prospective data on integrated treatment for musculoskeletal disorder patients (ClinicalTrials.gov Identifier: NCT02257723). The study protocol was approved by the Institutional Review Boards of Jaseng Hospital of Korean medicine. All participants gave written informed consent prior to participation.

 

Participants

 

Patients meeting the following criteria were included.

 

  1. Admission for treatment of neck pain or radiating arm pain
  2. Cervical IDH confirmed on MRI
  3. Diagnosis by KMD that main cause of chief complaint (neck pain or radiating pain) is cervical IDH

 

Patients meeting the following criteria were excluded.

 

  1. Main complaint other than neck pain or radiating pain
  2. Concomitant musculoskeletal complaint (e.g. low back pain, knee pain)
  3. Cause of neck pain unrelated to cervical IDH (e.g. spinal tumor, pregnancy, rheumatoid arthritis)
  4. Refusal to participate in the study or nonagreement to collection and disclosure of personal information for study purposes

 

KMDs assessed the cause of current neck pain or arm pain symptoms with reference to neurological test results (sensory loss, motor weakness, and tendon reflex) and MRI readings by radiology specialists. Patients who met the proposed inclusion criteria were visited at the inpatient ward on the first day of admission for assessment by a KMD, and followed up using a similar interview and survey process upon discharge. If a patient was admitted multiple times during the study period, only the first admission record was appraised and included.

 

Interventions

 

Though the treatment protocol was comprised with most frequented treatments for cervical IDH patients, any and all treatment methods not included in the treatment protocol were allowed and available to all physicians and patients and use of these treatments (type and frequency) were recorded in electronic medical records pragmatically. Conventional treatments such as pain medications and epidural injections (using local anesthetics such as lidocaine, steroids, and anti-adhesion adjuvants) were administered by a conventional rehabilitation specialist through KMD referral. Only non-surgical treatments were allowed during admission.

 

Complementary and Alternative Medicine Treatment Protocol

 

Herbal medicine was taken 3 times/day in pill (2 g) and water-based decoction form (120 ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, and Atractylodes japonica). These herbs were carefully selected from herbs frequently prescribed for IDH treatment in Traditional Chinese Medicine and Korean Medicine [22] and the prescription was further developed through clinical practice [23]. The main ingredients of the herbal medicine used in this study (Acanthopanax sessiliflorus Seem, Achyranthes japonica Nakai, Saposhnikovia divaricata Schischk, Cibotium barometz J. Smith, Glycine max Merrill, and Eucommia ulmoides Oliver) have been studied in vivo and in vitro as GCSB-5 for their anti-inflammatory [24], and nerve [25] and joint protective effects [26], and clinically for non-inferiority in safety and efficacy compared to Celecoxib in treatment of osteoarthritis [27].

 

Acupuncture was administered 1�2 sessions/day at cervical Ah-shi points and acupuncture points pertaining to neck pain. Ah-shi point acupuncture refers to acupuncture needling of painful or pathological sites. Ah-shi points do not exactly match tender points or Buding, Tianying points, but generally correspond to points that induce relaxation or pain upon palpation [28].

 

The pharmacopuncture solution was prepared with ingredients similar to the orally administered herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, and Atractylodes japonica) by decocting and freeze drying, then mixing the prepared powder with normal saline and adjusting for acidity and pH. Pharmacopuncture was administered 1 session/day at cervical Hyeopcheok (Huatuo Jiaji, EX B2) and Ah-shi points up to 1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co. Korea).

 

Bee-venom pharmacopuncture was applied if the skin reaction test to bee-venom was negative. Diluted bee-venom solution (mixed with normal saline at a ratio of 1000:1) was injected at 4�5 cervical Hyeopcheok (Huatuo Jiaji, EX B2) and Ah-shi points at the physician�s discretion. Each point was injected with about 0.2 cc up to a total 0.5�1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co. Korea)

 

Chuna spinal manipulation [29, 30], which is a Korean manipulation method that combines conventional manipulation techniques with high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion, and manual force within the passive range, was conducted 3�5 sessions/week.

 

Outcome Measures

 

All outcomes were assessed by KMDs who had received prior training and education. Demographic and health behavior characteristics (sex, age, occupation, smoking, alcohol consumption, and underlying disease) were collected on the first day of admission using short surveys on current pain levels and neurological exams. Follow-ups were conducted at 2 weeks post-admission or upon discharge and after discharge.

 

NRS [31] uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by �0�, and the worst pain imaginable by �10�. NRS was assessed at admission, discharge, and long term follow-up. Due to lack of references on minimum clinically important difference (MCID) of neck pain or radiating pain for NRS, MCID for visual analogue scale (VAS) was used for further evaluation of NRS.

 

The NDI [32] is a 10-item survey that assesses the degree of disability from 0 to 5 in fulfilling daily activities. The total is divided by 50, then multiplied by 100. NDI was assessed at admission and discharge.

 

PGIC [33] was used to assess patient satisfaction rate of current state after admission. Satisfaction was rated with a 5-point scale ranging from very satisfactory, satisfactory, slightly satisfactory, dissatisfactory, and very dissatisfactory at discharge and long term follow-up.

 

Participants underwent physical and neurological examination at admission and discharge for objective motor and sensory evaluation of the cervical region. Range of motion (ROM) for neck flexion and extension, distraction, compression, Valsalva, Spurling, Adson�s, and swallowing tests, and upper extremity motor strength and sensory tests and deep tendon reflex tests were performed.

 

Safety Assessments

 

All potential adverse events regarding treatment, ranging from skin and local reactions to systemic reactions, and including change or aggravation in pain patterns were carefully observed, recorded and reported during admission. Adverse events associated with bee-venom therapy are known to range from skin reactions to severe immunological responses, and therefore adverse reactions including systemic immunological reactions requiring additional treatment (e.g. antihistaminic agents) were closely monitored. . Blood cell count, liver and renal function tests, and inflammatory activity tests were conducted in all patients at admission, and if there was an abnormal finding requiring follow-up as assessed by KMDs and conventional doctors, relevant markers were rechecked. A total 46 patients were judged to require follow-up at admission by KMDs and conventional doctors and were followed up accordingly during hospital stay, of which 9 patients showed abnormal findings in liver function at admission. Liver function was tracked in these nine patients. Presence of liver injury was also measured to assess possibility of drug-induced liver injury from herbal or conventional medicine intake using a definition of (a) ALT or DB increase of 2� or over the upper limit of normal (ULN) or (b) combined AST, ALP, and TB increase, provided one of them is above 2?�?ULN.

 

Statistical Methods

 

All analyses were conducted using statistical package SAS version 9.3 (SAS Institute, Cary, NC, USA), and p?<?0.05 was regarded to be statistically significant. Continuous data is presented as mean and standard deviation, and categorical data as frequency and percent (%). The mean difference in NRS of neck pain, NRS of radiating pain, and NDI between admission (baseline), discharge and long term follow-up was analyzed for significance with 95 % confidence intervals (CIs). Satisfaction rate assessed with a 5-point Likert scale at long term follow-up was recategorized into binary values of satisfactory (very satisfactory, or satisfactory) and dissatisfactory (slightly satisfactory, dissatisfactory, and very dissatisfactory). Multivariable logistic regression analysis was conducted to calculate odds ratios (ORs) and 95 % CIs, and estimate the influence of predictive factors on satisfaction rate. Baseline factors that met p?<?0.10 in univariate analysis were included in the final model with age and sex, and factors were selected using stepwise method (p?<?0.05).

 

Results

 

During the study period 784 patients with neck disorders were admitted, and of these, 234 patients were diagnosed with cervical IDH with no other major musculoskeletal complaints. Of the 234 cervical IDH patients, 175 patients had no missing values in NRS and NDI at admission and at 2 weeks post-admission or at discharge (short term follow-up). Ten patients were re-admissions and after inclusion of initial admission data if initial admission was during the study period, 165 patients remained. Long term follow-up assessments were conducted in 117 patients. In the non-long term follow-up group (n?=?48), 23 patients did not answer the phone, 10 refused to participate in the long term follow-up, and 15 had since changed number or had incoming calls barred (Fig. 1). Baseline characteristics by long term follow-up group and non-long term follow-up group are listed in Table 1. Though there were no other marked differences between the 2 groups, 29 patients in the long term follow-up group had been recommended surgery (24.8 %), while only 1 patient in the non-long term follow-up group (0.02 %) had been recommended.

 

Figure 1 Flow Diagram of the Study

Figure 1: Flow Diagram of the Study

 

Table 1 Baseline Demographic Characteristics

Table 1: Baseline demographic characteristics.

 

Average length of hospital stay was 20.8?�?11.2 days. The majority of participants received inpatient treatment focused on Korean medicine and CAM. Herbal medicine was taken in accordance with the treatment protocol in decoction form by 81.8 % of patients and in pill form in 86.1 %, and the other patients were prescribed other herbal medicines at the KMD�s discretion. In use of conventional treatments not specified in the CAM treatment protocol, 18.2 % patients took analgesic medications or intramuscular injections an average 2.7?�?2.3 times, and 4.8 % patients were administered 1.6?�?0.5 epidural injections during hospital stay (Table 2). We did not implement restrictions in pharmacological treatment for study purposes, and allowed conventional medicine physicians full freedom to assess and prescribe conventional medicine as the physician deemed necessary for the patient. NSAIDs, antidepressants, and muscle relaxants were the main medicines used, and opioids were administered in the short-term in only 2 patients.

 

Table 2 Length of Hospital Stay and Interventions Administered During Stay

Table 2: Length of hospital stay and interventions administered during stay.

 

NRS of neck pain, NRS of radiating pain, and NDI all decreased significantly at discharge and at long term follow-up compared to baseline (admission) (Table 3). The major site of pain of neck and radiating arm pain showed a decrease larger than MCID (NRS decrease of 2.5 or larger in neck pain or radiating pain), and NDI scores also improved over the MCID score of 7.5 [34, 35]. Difference in NRS at discharge in the long term follow-up group (n?=?117) was 2.71 (95 % CI, 2.33, 3.09) for neck pain, 2.33 (95 % CI, 1.9, 2.77) for arm pain, and that of NDI, 14.6 (95 % CI, 11.89, 17.32). Difference in NRS at long term follow-up for neck pain and arm pain from baseline was 3.15 (95 % CI, 2.67, 3.64) and 2.64 (95 % CI, 1.99, 3.29), respectively. Difference in NRS at discharge in the non-long term follow-up group (n?=?48) was 2.83 (95 % CI, 2.22, 3.45) for neck pain, 2.48 for arm pain (95 % CI, 1.84, 3.12), and that of NDI was 14.86 (95 % CI, 10.41, 19.3). The between-group difference in effect between admission and discharge in the long term follow-up and non-long term follow-up patients was not significant (NRS of neck pain : p-value?=?0.741; NRS of radiating arm pain: p-value?=?0.646; Neck disability index: p-value?=?0.775).

 

Table 3 Comparison of Numeric Rating Scale, Radiating Arm Pain and Neck Disability Index Score

Table 3: Comparison of numeric rating scale for neck and radiating arm pain and neck disability index score in long term follow-up group and non-long term follow-up group.

 

The average period from admission to long term follow-up was 625.36?�?196.7 days. All 165 patients answered the PGIC at discharge, and of these patients 84.2 % replied that their state was �satisfactory� or higher. A total 117 patients replied to PGIC at long term follow-up, and 79.5 % rated their current state to be �satisfactory� or higher. PGIC was reported to be very satisfactory in 48 patients (41.0 %), satisfactory in 45 (38.5 %), slightly satisfactory in 18 (15.4 %), and dissatisfactory in 6 (5.1 %). Nine patients had undergone surgery (7.6 %), while 21 patients replied that they were currently receiving treatment. Of patients currently under treatment, 10 patients (8.5 %) continued to receive CAM, 12 patients (10.3 %) had selected conventional treatment, and 1 patient was receiving both (Table 4).

 

Table 4 Period from Admission Date to Long Term Follow Up and Patient Global Impression of Change

Table 4: Period from admission date to long term follow-up, and patient global impression of change, ever-surgery and current treatment status in long term follow-up group.

 

Sex, age, and unilateral radiating pain satisfied p?<?0.10 in univariate analysis of baseline characteristics. Satisfaction rate increased with older age in multivariate analysis. Patients with unilateral radiating arm pain tended to be more satisfied with treatment that those without radiating pain. Also, patients receiving CAM treatment showed higher satisfaction rates than patients receiving no treatment (Table 5).

 

Table 5 Assessment of Predictive Baseline Factors

Table 5: Assessment of predictive baseline factors associated with satisfaction rate.

 

Liver function was measured in all patients at admission, and nine patients with liver enzyme abnormalities at admission received follow-up blood tests at discharge. Liver enzyme levels returned to normal in 6 patients at discharge, while 2 retained liver enzyme abnormalities, and 1 patient sustained liver injury and on further assessment was diagnosed with active hepatitis showing Hbs antigen positive and Hbs antibody negative. There were no cases of systemic immunological reactions to bee venom pharmacopuncture requiring additional treatment and no other adverse events were reported.

 

Discussion

 

These results show that inpatient treatment primarily focused on CAM maintains long term effects of pain relief and functional improvement in cervical IDH patients with neck pain or radiating arm pain. NRS and NDI scores at discharge and at long term follow-up all displayed significant decrease. Also, as statistical significance and clinical significance may differ, we checked for MCID and confirmed that both NRS and NDI scores improved over MCID. MCID has been reported at 2.5 in VAS for neck pain and radiating arm pain, and 7.5 in NDI scores [34, 35]. Average improvement in pain and functionality scales all exceeded MCID, and these results are likely to be reflected in patient satisfaction rate. Out of 165 patients, 128 patients (84.2 %) rated their current state as �satisfactory� or higher at discharge. At long term follow-up, 9 (7.6 %) out of 117 patients were confirmed to have received neck surgery, and most patients showed continued decrease in NRS and NDI. In addition, 96 patients (82.1 %) currently did not receive treatment for neck pain symptoms, and 93 patients (79.5 %) replied their state was �satisfactory� or higher. As comparison of between-group difference in the long term follow-up and non-long term follow-up patients was not designed a priori, this data may be regarded to be a post hoc data analysis. The between-group difference in effect between admission and discharge in the long term follow-up and non-long term follow-up patients was not significant, and in MCID, which could be considered a more clinical measure, the 2 groups produced comparable results.

 

Despite the fact that all patients underwent intensive Korean medicine treatment for the duration of hospital stay, no adverse events related to treatment were reported, demonstrating the safety of integrative medicine with focus on CAM. The authors had previously conducted a retrospective study to assess safety of herbal medicine and combined intake of herbal and conventional medicine in liver function test results of 6894 inpatients hospitalized at Korean medicine hospitals, and test results of the cervical disc herniation patients included in the present study were also described [36].

 

A major strength of this study is that it depicts clinical practice and the results reflect treatment as it is actually practiced in Korea in conventional and Korean medicine integrative treatment settings focused on CAM. Protocol treatment was standardized and comprised of interventions whose efficacy has been confirmed in pilot studies and frequently used in clinical practice, but the protocol also allowed for individual tailoring according to patient characteristics and symptoms as seen necessary by KMDs, and the percentage and frequency of these deviations were recorded. The satisfaction rate assessed at discharge not only reflects patient attitude toward treatment effect, but also increased medical costs entailed by inclusion of various treatments. Taking into account that the participants of this study were not patients recruited through advertisements, but patients visiting a Korean medicine hospital from personal choice receiving no economic compensation for study participation, the fact that most patients� satisfaction rate was high is particularly noteworthy. The results of this study contribute to an evidence base for superior efficacy of compositive treatment over individual treatment in patients diagnosed with cervical IDH, and verify feasibility of clinical implementation with consideration for increased compositive treatment costs.

 

The largest limitation of our study is probably the inherent quality of a prospective observational study lacking a control. We are unable to draw conclusions on whether the suggested CAM integrative treatment is superior to an active control (e.g. surgery, conventional non-surgical intervention) or the natural course of disease. Another limitation is the heterogeneity of the patient groups and treatment composition. Participants were cervical IDH patients of varying symptoms, severity and chronicity whose progress are generally known to differ, and interventions included conventional treatments such as epidural injections or pain medications in some cases. Therefore it would be more accurate to construe these results to be the effect of a conventional and Korean medicine integrative treatment system than that solely of CAM integrative treatment. The compliance rate of 74 % (n?=?175) at 2 weeks post-admission or discharge out of 234 admitted patients is low, especially considering the short follow-up period. This low compliance may be related to patient attitude toward study participation. As participants did not receive direct compensation for trial participation, they may have lacked incentive to continue participation, and the possibility that patients who refused follow-up assessment were dissatisfied with admission treatment should be considered. Long term assessment was conducted by phone interview in 117 patients (70 %) out of 165 baseline participants partly due to lapse in time, which limited the amount and quality of long term information that could be gathered and led to further patient loss from loss of contact.

 

Another limitation is that we failed to conduct more comprehensive medical evaluations. For example, although participants were diagnosed as disc herniation to be the main pathology based on MRI readings and neurological symptoms by KMDs, additional imaging information such as pathological disc level and severity of herniation were not collected. Also, data on subsequent recurrences, duration of all episodes and whether some were absolutely cured were not included in long term follow-up assessments, limiting multidimensional evaluation. In addition, while these cervical IDH patients required admission for severe neck and arm pain and consequent functional disability, the fact that this was the first attack of neck pain for many may have been cause for more favorable outcome.

 

However, the influence of long term follow-up compliance may not be confined to availability but potentially be associated with long term treatment effectiveness. As difference in characteristics of long term follow-up and non-long term follow-up patients may be reflected in short-term outcomes assessed at discharge and types and amount of additional conventional treatment, the fact that this study did not consider for these potential effects through additional analyses is a further limitation of this study.

 

Controversy still surrounds the efficacy of treatments for cervical IDH. While epidural steroid injections are the commonest modality of conservative treatment used in the United States [37] various systematic reviews show that effects are highly variable and not conclusive [38�44]. Two approaches are widely used in epidural injections: interlaminar and transforaminal approaches. The transforaminal approach has been criticized for safety risks [45�50], and though safer than the transforaminal approach, the interlaminar approach also holds potential risks [51�56]. Reports on the efficacy of conventional medicine for neuropathic pain show conflicting results [57�61], and study results on physical therapy are also inconsistent [62�64].

 

Gebremariam et al. [65] evaluated the efficacy of various cervical IDH treatments in a recent review, and concluded that though the single published study on conservative treatment versus surgery showed that surgery led to better results than conservative treatment, lacking intergroup analysis, there is no evidence supporting that one treatment is more superior. Despite recommendations for initial conservative treatment and management, some patients may select surgery for cervical IDH to the main aim of alleviating radiating pain in neuropathy and preventing progression of neurological damage in myelopathy [66]. Although the evidence base of conventional conservative and surgical treatments for cervical IDH weighing the benefits and harms is somewhat insufficient, the area has been extensively studied, while there is a distinct paucity of correlative studies on CAM.

 

Manchikanti et al. [67] stated in a 2 year follow-up study comparing epidural injection treatment with lidocaine and a mix of lidocaine and steroids for cervical IDH that NRS in the lidocaine group was 7.9?�?1.0 at baseline, and 3.8?�?1.6 at the 2 year follow-up, while NRS in the lidocaine and steroid group was 7.9?�?0.9 at baseline, and 3.8?�?1.7 at the 2 year follow-up. NDI in the lidocaine group was 29.6?�?5.3 at baseline, and 13.7?�?5.7 at the 2 year follow-up, and NDI in the lidocaine and steroid group was 29.2?�?6.1 at baseline, and 14.3?�?6.9 at the 2 year follow-up. When compared to our study, though improvement in NRS is slightly bigger in the study by Manchikanti et al., that of NDI is similar. The baseline NRS was higher at 7.9 in this previous study, and they did not differentiate between neck pain and radiating pain in NRS assessment.

 

The 1 year follow-up results comparing conservative treatment and plasma disc decompression (PDD) for contained cervical IDH show that VAS scores decreased 65.73, while NDI decreased 16.7 in the PDD group (n?=?61), and that VAS scores decreased 36.45, and NDI decreased 12.40 in the conservative treatment group (n?=?57) [68]. However, the study subject was limited to contained cervical IDH, the outcome measure for pain was VAS preventing direct comparison, and the follow-up period was shorter than our study.

 

The model of integrative treatment used at a Korean medicine hospital may be highly disparate from CAM treatment models used in Western countries. Although CAM treatment is gaining widespread popularity in the West, CAM is usually limited to �complementary� rather than �alternative� medicine, and is generally practiced by conventional practitioners as an adjunctive to conventional treatment after education on acupuncture/naturopathy/etc. or through referral to CAM specialists, of whom some do not hold individual practice rights. On the other hand, Korea adopts a dual medical system where KMDs hold practice rights equal to conventional practitioners, and she does not employ a primarily family practice-based medical system, allowing patients the freedom of primary treatment selection of conventional treatment or Korean medicine treatment. The participants of this study were patients visiting and admitted to a Korean medicine hospital for Korean medicine treatment of cervical IDH, and the integrative treatment model implemented at this Korean medicine hospital does not use CAM as a supplementary measure. Therefore, treatment comprised of CAM treatment such as acupuncture, herbal medicine, Chuna manipulation, and bee-venom pharmacopuncture in most patients, and conventional treatment was administered by conventional doctors through referral in a select few. A total 18.2 % of patients received analgesic medications prescriptions 2.7 times over an average admission period of 20.8 days, which is equivalent to 1�2 days worth�s prescription (calculated as 2 times/day), and epidural injections were administered to only 4.8 %, which is low considering that these patients required admission. It can be surmised that the main objective of admission in conservative treatment for most cervical IDH patients is alleviation of pain. The fact that many inpatients displayed significant pain and functional recovery in this study holds relevance for patients considering selecting a Korean medicine hospital for conservative treatment over surgery. Also, patients were confirmed to have maintained their improved state at long term follow-up, and only 9 received surgery out of the 117 patients assessed in the long term.

 

Patients were divided into 2 groups by satisfaction rate as evaluated at long term follow-up with PGIC, and multivariable logistic regression analysis was conducted on baseline characteristics to assess predictive factors for satisfaction and dissatisfaction. Older age was associated with higher satisfaction rate, and unilateral radiating pain was shown to be related with higher satisfaction rates than no radiating pain. In addition, patients receiving CAM treatment were associated with higher satisfaction rates compared to those not receiving treatment. This could be partly explained by the fact that more older patients may have higher levels of pain and be in more advanced stages of degeneration, resulting in more favorable and satisfactory treatment outcomes. Similarly, patients with unilateral radiating pain suffer neurological symptoms likely to be more severe than those with no radiating pain. In addition, patients continuing to receive CAM treatment may be more favorably predisposed toward CAM, resulting in higher satisfaction rates.

 

While numerous prospective long term studies have been conducted on injection treatment or surgical procedures, those on CAM treatment and inpatient treatment are few. The results of this study are comparable to the prospective long term results of injection treatment. Few studies have been conducted on admission treatment for patients with a main complaint of cervical IDH, which may be related with the difference in general healthcare systems.

 

Conclusions

 

In conclusion, although the observational nature of this study limits us from drawing more decisive conclusions lacking a control, 3 weeks� integrative inpatient treatment mainly comprised of CAM applied to actual clinical settings may result in satisfactory results and pain and functional improvement maintained in the long term in neck pain or radiating arm pain patients diagnosed with cervical IDH.

 

Acknowledgements

 

This work was supported by Jaseng Medical Foundation.

 

Abbreviations

 

  • IDH Intervertebral disc herniation
  • CAM Complementary and alternative medicine
  • KMD Korean medicine doctor
  • NRS Numeric rating scale
  • NDI Neck disability index
  • PGIC Patient global impression of change
  • MCID Minimum clinically important difference
  • VAS Visual analogue scale
  • ROM Range of motion
  • ULN Upper limit of normal
  • CI Confidence interval
  • OR Odds ratio
  • PDD Plasma disc decompression

 

Footnotes

 

Competing interests: The authors declare that they have no competing interests.

 

Authors� contributions: SHB, JWO, JSS, JHL and IHH conceived of the study and drafted the manuscript, and SHB, MRK and IHH wrote the final manuscript. SHB, JWO, YJA and ARC participated in data acquisition, and KBP performed the statistical analysis. YJL, MRK, YJA and IHH contributed to analysis and interpretation of data. SHB, JWO, JSS, JHL, YJL, MRK, YJA, ARC, KBP, BCS, MSL and IHH contributed to the study design and made critical revisions. All of the authors have read and approved the final manuscript.

 

Contributor information:�Ncbi.nlm.nih.gov/pmc/articles/PMC4744400/

 

In conclusion, migraine and cervical disc herniation treatment such as manual therapy as well as integrated complementary and alternative medicine may be effective towards the improvement and management of their symptoms. Information referenced from the National Center for Biotechnology Information (NCBI). The above research studies utilized a variety of methods to conclude the final results. Although the findings were shown to be effective migraine and cervical disc herniation treatment, further research studies are required to determine their true efficacy. 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

 

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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!

 

OTHER IMPORTANT TOPICS: EXTRA: Sports Injuries? | Vincent Garcia | Patient | El Paso, TX Chiropractor

 

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