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Research Studies

Back Clinic Research Studies. Dr. Alex Jimenez has compiled study and research projects that are pertinent to the science and art of chiropractic medicine. The subsets can be classified as following: Case Study, Case Series, Cross-Sectional, Cohort, Case-Control, and Randomized Control Trials. Each subset of study profiles has its merits and scientific significance.

It is our intention to bring clarity to present-day research models. We will discuss and present significant clinical interpretations that may serve outpatients well. Great care in selecting appropriate and well-documented models has been enforced in our blog. We gladly will listen and heed comments on the discussed subject matters presented. For answers to any questions you may have please call Dr. Jimenez at 915-850-0900


Safe Physiotherapy Interventions in Cervical Disc Herniations

Safe Physiotherapy Interventions in Cervical Disc Herniations

Recognizing clinical and experimental evidence, physiotherapy is a healthcare profession that helps restore and maintain function to individuals affected by injury, disease or disability by using mechanical force and movements, manual therapy, exercise and electrotherapy, as well as through patient education and advice. The terms physiotherapy and physical therapy are used interchangeably to describe the same healthcare profession. Physiotherapy is recommended for a variety of injuries and conditions, and it can help support overall health and wellness for people of all ages.

 

For further notice,�physiotherapy services may be offered alongside chiropractic care, to provide a cautious and gentle manipulation and/or mobilization of the cervical and thoracic spine in the instance of a large cervical disc herniation. Cervical disc herniations can cause pain and discomfort, numbness and weakness in the neck, shoulders, chest, arms and hands.

Abstract

 

A 34-year-old woman was seen in a physiotherapy department with signs and symptoms of cervical radiculopathy. Loss of cervical lordosis and a large paracentral to intraforaminal disc prolapse (8?mm) at C5�C6 level was reported on MRI. She was taking diclofenac sodium, tramadol HCl, diazepam and pregabalin for the preceding 2?months and no significant improvement, except temporary relief, was reported. She was referred to physiotherapy while awaiting a surgical opinion from a neurosurgeon. In physiotherapy she was treated with mobilisation of the upper thoracic spine from C7 to T6 level. A cervical extension exercise was performed with prior voluntary extension of the thoracic spine and elevated shoulders. She was advised to continue the same at home. General posture advice was given. Signs and symptoms resolved within the following four sessions of treatment over 3?weeks. Surgical intervention was subsequently deemed unnecessary.

 

Background

 

Surgical interventions are commonly recommended in large cervical prolapsed discs and the importance of non-aggressive physiotherapy interventions is less recognised and poorly understood. We present interventions that were associated with resolution of symptoms of radiculopathy resulting from a larger cervical herniated disc. These interventions, if applied correctly, may help to reduce the number of surgeries required for cervical prolapsed discs.

 

Case Presentation

 

The patient was a 34-year-old woman. She was seen in the physiotherapy department with a complaint of left-sided neck and shoulder pain. The pain was radiating to her left arm and there was associated numbness. The duration of symptoms was more than 2?months with no history of trauma. The pain was present on waking in the morning and gradually increased during the day. She was otherwise a healthy woman. Neck movements were aggravating the symptoms. She was seen in the acute hospital accident and emergency department (A&E) twice since onset and had been taking diclofenac sodium, tramadol HCl, diazepam and pregabalin. An MRI was planned and a request was sent for physiotherapy during the MRI waiting period. A neurosurgical review was requested by the A&E consultant upon receipt of the MRI report 7?weeks later.

 

Patient examination in the physiotherapy department revealed a normal gait pattern, her left arm held in front of her chest with the left shoulder slightly elevated. Her active range of neck motion was restricted and was painful on the left side. Flexion and rotation to the left were aggravating her arm and shoulder pain. Strength deficits were noted in the left elbow flexors and wrist extensors (4/5) when compared with the right side. There was paraesthesia along the radial border of the forearm and thumb regions. The brachioradialis reflex was diminished and biceps reflex was sluggish. Triceps and plantar reflexes were normal. Passive intervertebral movements were tender at C5�C6 level and were reproducing the pain. Sustained pressure at C7 and below was easing the pain and also improving the neck range of motion. The patient was deemed to have C6 radiculopathy. The MRI report, available 2?weeks after the commencement of physiotherapy, confirmed the diagnosis.

 

Investigations

 

The findings from the plain cervical x-ray were unremarkable. MRI showed (Figure 1) loss of cervical spine lordosis, a left paracentral to intraforaminal lesion with 8?mm hernia, which indented the cord and obstructed the left paracentral recess and neural foramen.

 

Figure 1 Loss of Cervical Spine Lordosis and Large Disc Herniation at C5 and C6 on MRI

Figure 1: Loss of cervical spine lordosis and large disc herniation at C5 and C6 on MRI.

 

Differential Diagnosis

 

  • Cervical myelopathy.

 

Treatment

 

The patient received pharmacological treatment for the initial two symptomatic months, which included diclofenic sodium, tramadol, diazepam and pregabalin (lyrica) tablet. Physiotherapy was started after 2?months. Physiotherapy intervention consisted of mobilisation of the thoracic spine, resisted cervical extension exercises, a home programme of exercises and advice regarding the posture.

 

Mobilisation of the thoracic spine was administered in the prone lying position from C7 toT6 level. Mild intensity oscillations (15?reps) in an anterosuperior direction were directly applied to each of the spinal segments, through the thumb over the spinous processes, during the first visit. The applied force was enough to appreciate intervertebral movement in each segment and without significant pain. High-intensity oscillations (10�20) were applied during the subsequent treatment sessions. The patient was asked for symptom feedback during treatment.

 

Cervical spine extension exercises were carried out in a sitting position. The patient was asked to extend her thoracic spine with lungs fully inflated and shoulders elevated followed by extension of her cervical spine. Head extension was moderately resisted by the therapist near the end range of extension for 5�10?s and brought back to neutral after each resisted movement. The resisted movement was repeated at least three times with intervals of 30?s. The patient was asked to perform the same exercise at home every hour during the day.

 

The patient was educated regarding the rationale of extension exercises, sitting and lying posture and their effects on the spine. The duration of each session was approximately 20�25?min.

 

Dr. Alex Jimenez’s Insight

Surgical interventions are generally recommended and widely considered for large cervical disc herniations. Although less recognized and often misunderstood, however, physiotherapy can be just as effective towards improving herniated discs in the cervical spine, excluding the need for surgery, according to the research study. Pharmacological treatments are also commonly used to help temporarily reduce symptoms alongside physiotherapy interventions. Cautious and gentle, spinal manipulation and mobilization of the cervical spine should be performed in the case of large cervical disc herniations to avoid aggravating the injury and/or condition. As recommended by a physiotherapist, or other healthcare professional experienced in physiotherapy, proper exercise can restore the function of the cervical spine and prevent regression of large prolapsed discs along the spine. Through appropriate physiotherapy intervention as well as through patient safety and compliance, the retraction of the cervical herniated discs is possible.

 

Outcome and Follow-Up

 

Pharmacological interventions were helpful to reduce the patient’s pain on a temporary basis. Symptoms were recurring and resolution was not sustainable. The symptoms started improving after the first physiotherapy session and continued to improve during the subsequent sessions. It fully resolved in four sessions extended over 3?weeks. The patient was reviewed 4?months after the resolution of symptoms and there was no recurrence of symptoms. She was reviewed by a neurosurgeon and the surgical option was withdrawn.

 

Discussion

 

Stiffness of the thoracic spine has been linked to the painful pathologies of the cervical spine, and manipulation of the thoracic spine has been shown to improve painful symptoms and mobility of the cervical spine. However, cervical disc herniations of greater than 4?mm are considered inappropriate for physiotherapy interventions such as traction and manipulation. Spinal manipulation refers to a passive movement thrust of high velocity and low amplitude, usually applied at the end range of movement and is beyond the patient’s control. Manipulation of the cervical spine is an aggressive procedure, which carries various risks and is often associated with worsening of symptoms. Manipulation was not considered in the treatment options for this patient because of the risks associated with it, and also because of patient’s anxiety and lack of MRI-confirmed diagnosis.

 

Active extension of the thoracic spine increases the range of motion of the cervical spine and, in these authors� clinical experience, relieves minor neck symptoms. Conversely, thoracic spine kyphosis, such as slouch sitting, restricts the mobility of the cervical spine and aggravates the painful symptoms. A good sitting posture is constituted by a slightly extended thoracic spine. Therefore, active extension of the thoracic spine prior to cervical extension may improve cervical movements and restore cervical curvature.

 

It is believed that excessive pressure during flexion on the anterior aspect of the intervertebral discs pushes the nucleus pulposus posteriorly and causes herniations. Conversely, cervical lordosis might have the reverse effect�that is, decreases pressure on the anterior aspect of the discs and may create a suction effect which retracts the herniated contents. Therefore, a combination of short duration and repeated movements at the end of extension may serve as a suction pump and possibly retract the extruded content of the disc. Active cervical extension exercises, with an extended thoracic spine posture, may have been the key element in a home exercise programme to restore lordosis of the cervical spine and relieve radiculopathy symptoms in the current case. This may possibly have been due to the retraction of the herniated discs.

 

Spinal mobilisation refers to a gentle, oscillatory, passive movement of a spinal segment. These are applied to a spinal segment to gently increase the passive range of motion. It allows the patient to report aggravation of pain and to resist any unwanted movements. No mobilisation treatment was administered at C5�C6 level as palpation at this level was aggravating the symptoms. Segments below this level were mobilised with emphasis at C7�T1 level. Any treatment at the affected segment was likely to irritate the nerve root and thereby increase the inflammatory process.

 

Various interventions are reported for the treatment of prolapsed discs. Saal et al reported the use of traction, specific physical therapy exercise, oral anti-inflammatory medication and patient education in the treatment of 26 patients with herniated cervical discs (<4?mm) and reported significant improvement in outcomes for 24 patients. They observed that surgery for disc herniations occurs when a patient has significant myotomal weakness, severe pain or pain that persists beyond an arbitrary conservative treatment period of 2�8?weeks.

 

Spontaneous regressions of cervical disc protrusions are reported in the literature. However, spontaneous regressions of herniated cervical discs are speculated to be rare. Various factors related to regression are hypothesised and theorised. Pan et al summarised the factors related to the resorption of herniated disc as: the age of the patients; dehydration of the expanded nucleus pulposus; resorption of haematoma; revascularisation; penetration of herniated cervical disc fragments through the posterior longitudinal ligament; size of disc herniations; and existence of cartilage and annulus fibrosus tissue in the herniated material. Some studies on spontaneous regressions of discs reported that the patients were receiving physiotherapy. Physiotherapy interventions are not defined in any of these studies, however. Therefore, it is possible that disc regressions in these studies may be due to similar physiotherapy interventions as described here, or the patients were practising techniques and adopting postures as reported in the current case.

 

Learning Points

 

  • Thoracic spine mobilisation improves cervical spine biomechanics and can be considered in conjunction with other interventions in all painful conditions of the cervical spine.
  • Active extension of the thoracic spine facilitates movements of the cervical spine and may help regression of large prolapsed discs.
  • There is a possibility of retraction of herniated cervical discs through appropriate physiotherapy intervention.
  • Patient education ensures safety and compliance to therapist advice.
  • Meticulous assessment and patient feedback guides the therapist in selection of intensity of mobilisation.

 

Footnotes

 

Competing interests: None.

 

Patient consent: Obtained.

 

In conclusion,�physiotherapy, or physical therapy, is used to treat various injuries, diseases and disabilities, through the use of mechanical force and movements, manual therapy, exercise, electrotherapy, and through patient education and advice to restore and maintain function. As in the case above, physiotherapy can be recommended and considered as treatment before referring to surgical interventions of large cervical disc herniations. 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: Sciatica

 

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

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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References
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2.�Walser RF, Meserve BB, Boucher TR.�The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials.�J Man Manipulative Ther�2009;17:237�46.�[PMC free article][PubMed]
3.�Krauss J, Creighton D, Ely JD, et al.�The immediate effects of upper thoracic translatoric spinal manipulation on cervical pain and range of motion: a randomized clinical trial.�J Man Manipulative Ther2008;16:93�9.�[PMC free article][PubMed]
4.�Saal JS, Saal JA, Yurth EF.�Nonoperative management of herniated cervical intervertebral disc with radiculopathy.�Spine (Phila Pa 1976)�1996;21:1877�83.�[PubMed]
5.�Murphy DR, Beres JL.�Cervical myelopathy: a case report of a �near-miss� complication to cervical manipulation.�J Manipulative Physiol Ther�2008;31:553�7.�[PubMed]
6.�Leon-Sanchez A, Cuetter A, Ferrer G.�Cervical spine manipulation: an alternative medical procedure with potentially fatal complications.�South Med J�2007;100:201�3.�[PubMed]
7.�Scannell JP, McGill SM.�Disc prolapse: evidence of reversal with repeated extension.�Spine (Phila Pa 1976)�2009;34:344�50.�[PubMed]
8.�Gurkanlar D, Yucel E, Er U, et al.�Spontaneous regression of cervical disc herniations.�Minim Invasive Neurosurg�2006;49:179�83.�[PubMed]
9.�Mochida K, Komori H, Okawa A, et al.�Regression of cervical disc herniation observed on magnetic resonance images.�Spine (Phila Pa 1976)�1998;23:990�5; discussion 6�7.�[PubMed]
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11.�Westmark RM, Westmark KD, Sonntag VK.�Disappearing cervical disc. Case report.�J Neurosurg1997;86:289�90.�[PubMed]
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13.�Teplick JG, Haskin ME.�Spontaneous regression of herniated nucleus pulposus.�AJR Am J Roentgenol1985;145:371�5.�[PubMed]
Close Accordion
Traditional Chinese Medicine for Low Back Pain Due to Lumbar Disc Herniation

Traditional Chinese Medicine for Low Back Pain Due to Lumbar Disc Herniation

Understanding the following, traditional Chinese medicine utilizes herbal medicines as well as various mind and body practices, such as acupuncture and tai chi, in order to treat or prevent numerous health issues. Traditional Chinese medicine, or TCM, originated in ancient China and has evolved over thousands of years. TCM has been primarily used as a complementary health approach along with other alternative treatment options like chiropractic care. Like TCM, chiropractic care is an alternative healthcare approach focused on the diagnosis, treatment and prevention of a variety of injuries and conditions of the musculoskeletal and nervous system, with an emphasis on manual manipulations and adjustments of the spine. As a doctor of chiropractic, or DC, TCM can also be offered to treat various types of injuries and conditions.

 

On a personal note, integrative TCM conservative therapies have been utilized to help treat symptoms of low back pain due to lumbar disc herniation, or LDH. Disc material from a ruptured or herniated disc in the lumbar spine can irritate or compress one or several of the nerves found in the lower spine. Pressure along the sciatic nerve can cause symptoms of sciatica, such as pain and discomfort, burning and tingling sensations, and numbness which may radiate from the buttocks into the leg and occasionally, down to the foot.�A randomized controlled trial was conducted in order to measure the outcomes of traditional Chinese medicine for low back pain due to LDH. The results have been recorded below.

 

Abstract

 

Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3?:?1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, ?16.62 points, P < 0.001 in VAS; ?15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (?7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.

 

Introduction

 

Lumbar disc herniation (LDH) is a common disease and a major contributing factor of low back pain. Although many studies have confirmed that surgery is more effective for LDH, conservative therapies have also been recognized for their therapeutic efficacy. Considering the fact that 20% of patients still have pain after surgery, 7% to 15% of surgical patients may have failed back surgery syndrome, and some patients are scared of surgery, conservative treatment is still one of the primary means for LDH.

 

In China, TCM is one of the main conservative treatments for LDH. Previous studies have confirmed that some TCM therapies have certain effects on low back pain due to LDH. These include acupuncture, oral administration of Chinese medicine, external application of Chinese medicine, Chinese Tuina (massage), and TCM-characteristic functional exercise. Clinically, these therapeutic methods are not used alone but often in combination. Recently, the clinical pathway of treating LDH with integrative TCM therapy has attracted attention. The Shi’s Traumatology Medical Center of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine is well recognized for its long-term commitment to the research on conservative treatment for LDH, coupled with a package protocol for LDH. However, high-quality research evidence is needed to support the effectiveness of the protocol.

 

This clinical trial aims to study the efficacy and safety of integrative TCM therapy for LDH and thus confirm its clinical effect.

 

Materials and Methods

 

Design

 

We conducted a multicenter, randomized controlled trial to evaluate the effectiveness of integrative TCM conservative treatment for patients with low back pain due to LDH. Patients were randomly assigned to an experimental group and a control group by the ratio of 3?:?1 using computer-generated numbers. The randomized treatment assignments were sealed in opaque envelopes and opened individually for each patient who agreed to be in the study. The nurse, who had no role in the design and conduct of the study, prepared the envelopes. Patients in the experimental group were treated with integrative TCM therapy once a day, for two weeks, whereas patients in the control group were treated with a two-week normal conservative intervention. At baseline, immediately after treatment, one and six months after treatment, visual analogue scale (VAS) and the Chinese Short Form Oswestry Disability Index (C-SFODI) were used as outcome assessment. This trial is registered in Chinese Clinical Trial Registry (No. ChiCTR-TRC-11001343).

 

Subjects

 

Patients were recruited from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Ruijin Hospital Affiliated to Shanghai Jiaotong University, and Yueyang Integrative Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine between January 2011 and August 2012.

 

Inclusion criteria: (1) aging 20�60 years; (2) having low back pain due to LDH (MRI scan confirmed lumbar disk herniation) and ruling out other relevant ongoing pathologies such as fractures, lumbar spondylolisthesis, tumor, osteoporosis, or infection; (3) willing to participate in this study and signing the informed consent.

 

Exclusion criteria: (1) having other pain syndromes; (2) experiencing a history of spinal surgery; (3) having neurological disease; (4) having psychiatric disease; (5) having serious chronic diseases that could interfere with the outcomes (e.g., cardiovascular disease, rheumatoid arthritis, epilepsy, or other disqualifying conditions); (6) scared of acupuncture; (7) pregnant or planning to become pregnant during the study; (8) having other diseases that the researchers believe is not suitable for the study.

 

Treatment

 

Experimental Group

 

Patients in the experimental group receive a two-week integrative TCM treatment. They were further divided into three subgroups (according to the duration from initial low back pain to getting treatment) for different treatment methods: acute stage (0�14 days), subacute stage (15�30 days), and chronic stage (>30 days).

 

Acute stage: (1) Electroacupuncture + (2) Chinese herbal injection (Salvia miltiorrhiza injection) + (3) external plaster (Compound Redbud Injury-healing Cataplasms); Subacute stag: (1) Chinese Tuina (massage) + (2) hot compress using Chinese medicine + (3) external plaster (Compound Redbud Injury-healing Cataplasms); Chronic stage: (1) TCM functional exercise + (2) external plaster (Compound Redbud Injury-healing Cataplasms).

 

Treatment Parameters

 

Electroacupuncture. Points: bilateral Dachangshu (BL 25) and Baihuanshu (BL 30).

 

Method: Insert the needles (the sterile, disposable needles, 0.3 � 75?mm, manufactured by Suzhou Medical Supplies Factory Co., Ltd.) 2.5 to 2.8?cun. Upon De Qi (needling sensation), connect the needles with the electroacupuncture device (Model: G6805-II, manufactured by Guangzhou KangMai Medical Devices Co., Ltd.), using a continuous wave, an electrical stimulation pulse wave of approximately 0.6?ms and a frequency of 20?Hz. The treatment was conducted once every day, 30?min for each treatment.

 

External Plaster. Compound Redbud Injury-healing Cataplasms (Approval no. Z19991106, manufactured by Shanghai LEY’s Pharmaceutical Co., Ltd.).

 

Main ingredients: Zi Jing Pi (Cortex Cercis Chinensis), Huang Jing Zi (Negundo Chastetree Fruit), Da Huang (Radix et Rhizoma Rhei), Chuan Xiong (Rhizoma Chuanxiong), Tian Nan Xing (Rhizoma Arisaematis), and Ma Qian Zi (Semen Strychni).

 

Functions: Circulates blood, resolves stasis, eliminates swelling, and alleviates pain.

 

Method: Apply the cataplasms to the most painful area, one plaster each time, once a day.

 

Chinese Herbal Injection. Salvia miltiorrhiza injection (Approval no. Z51021303, manufactured by Sichuan ShengHe Pharmaceutical Co., Ltd.).

 

The main ingredient of the injection is Salvia root P.E. It acts to circulate blood and resolve stasis.

 

Method: Intravenous dripping of 20?mL salvia miltiorrhiza injection and 250 mL 5% glucose, once a day.

 

Hot Compress Using Chinese Medicine. Ingredients: 20?g of Cang Zhu (Rhizoma Atractylodis), Qin Jiao (Radix Gentianae Macrophyllae), Sang Zhi (Ramulus Mori), Mu Gua (Fructus Chaenomelis), Hong Hua (Flos Carthami), Chuan Xiong (Rhizoma Chuanxiong), Hai Feng Teng (Caulis Piperis Kadsurae) and Lei Gong Teng (Radix Tripterygii Wilfordii), respectively. All herbs were provided by Shanghai Hongqiao Pharmaceutical Co., Ltd. and have been tested and qualified.

 

Method: Place the previous medicinal into a gauze bag, decoct with water for 20?mins and take it out. After the temperature cooled to 40~45�C, apply the back to the affected low back area for 30�40 minutes, once a day. The hot compress can help circulate blood and resolve stasis.

 

TCM Functional Exercise. The exercise is known as �Fei Yan Shi� (literally meaning �the flying swallow style�) in Chinese.

 

Method: Ask the patient to take a prone position, extend both hands backwards, lift the chest and lower limbs off the bed using the abdomen as a pivot, and then relax. Conduct this exercise once a day and repeat 4-5 times each time.

 

Functions: Strengthens the power of back muscles, increases the stability of the spine, and thus prevents relapses.

 

Chinese Tuina (Massage). Ask the patient to take a prone position and find the tenderness spots on the low back. Then apply gun-rolling (10?min), Anrou-pressing and kneading (10?min), and Tanbo-plucking (5?min) manipulation to the tenderness spots and surrounding areas. Conclude with oblique pulling manipulation of the low back. Conduct the treatment once a day.

 

Functions: Relaxes spasm of the low back muscles and adjusts lumbar subluxation.

 

After one week TCM treatment, if the patient’s lower back pain without any relief or even aggravated, the prescription of pain medication was adjusted according to clinical guidelines, detailed records the type and dose of pain medication taken by patients, and the patient was identified as no effect.

 

Control Group

 

Patients in the control group receive a two-week normal conservative treatment. Intervention measures include three sections, (1) health education. The patients were invited to receive LDH health education twice a week in outpatient; the health education was designed exclusively to inform patients about the natural course of their illness and the expectation of successful recovery, irrespective of the initial intensity of their pain, educate patients to avoid some bad habits that aggravate the disease, such as a sitting position for a long time and carrying heavy loads, and encourage patients to participate in social activities. (2) Rest: in addition to the normal sleep, the patients need to rest in bed for at least 1-2 hours a day. (3) Pain medication or physical therapy: after one week health education, if the patient’s lower back pain without any relief or even aggravated, the prescription of pain medication was adjusted according to clinical guidelines, detailed records the type and dose of pain medication taken by patients. And if the patients do not want to take pain medication, then the patients were referred to a physiotherapist.

 

Measurements

 

All outcomes were assessed by observers unaware of the grouping, at baseline (M1), immediately after the last intervention (M2). The followup included the assessments at one month (M3) and six months (M4) after the last intervention.

 

The primary outcome measure was the change in pain by the visual analogue scale (VAS), scores range 0 to 100, and a higher score indicates a greater pain, 0 means no pain, and 100 means intolerable pain.

 

The secondary outcome measure was the change in the Chinese Short Form Oswestry Disability Index (C-SFODI), range 0 to 100%. The C-SFODI consists of nine questions, which come from Oswestry Disability Index (ODI); omit the sex life question in Section??8, because this question is always unacceptable by Chinese. The C-SFODI calculation formula is actual cumulative score/45 � 100%, with higher percentage indicating more severe functional disability. And the study has shown that the C-SFODI has good reliability and validity.

 

Statistical Analysis

 

Our pretrial power calculation indicated that 81 patients in experimental group were required to detect a difference in pain relief based on the preliminary experiment data at a significant level of 5% (a two-sided t-test) with 80% power. In anticipation of a 20% attrition rate, we sought 102 patients at least in experimental group. Taking into account the poor effect of control therapy, 102 patients were included in the control group.

 

Between-group difference at baseline was analyzed using independent-samples t-test or Chi-square test. Changes in continuous measures were analyzed by analysis of variance (ANOVA). Effects were evaluated on an intention-to-treat basis (ITT), and participants who did not complete the followup period were considered not having any changes in scores. A two-sided P value of less than 0.05 indicated statistical significance. Results are presented as mean and standard deviation (SD) at M1 and as between-group difference with 95% confidence intervals (CI) at M2, M3, and M4.

 

Quality Control

Before the beginning of the study, all researchers have to receive protocol training. A clinic research coordinator (CRC) was employed to assist researchers in each center. A monitor was also appointed to ensure the quality of the research.

 

Dr. Alex Jimenez’s Insight

The above clinical trial focused on investigating the safety and effectiveness of TCM, or traditional Chinese medicine, for low back pain due to lumbar disc herniation as well as to confirm its clinical result. The participants of the research study with low back pain due to LDH were divided into two groups: the experimental group, which was treated with integrative TCM conservative therapy; and the control group, which was treated normal conservative treatment. The experimental group was then further divided into three subgroups. The details of each TCM treatment method used in the subgroups, including the name, ingredients, method and function of each, are described above. The outcomes were measured accordingly by observers unaware of the specific group divisions. The statistic results were properly analyzed by researchers who received protocol training before the start of the study.

 

Results

 

Between January 2011 and August 2012, a total of 480 patients with low back pain due to LDH were recruited, 72 were rejected due to exclusion criterions, and 408 eligible patients were randomly assigned in accordance with the ratio of 3?:?1 to the experimental group and the control group, 306 in the experimental group and 102 in the control group. Patients in the experimental group all completed a two-week treatment. In the control group, at the second week one patient in the control group was unwilling to continue to participate and withdrew his informed consent, and two patients took Fenbid (500?mg for each dose, 2 doses a day) since the pain worsened during treatment (Figure 1).

 

Figure 1 Screening with Randomization and Completion Evaluations

Figure 1: Screening, randomization, and completion evaluations from the baseline to six-month followup, LDH = lumbar disc herniation.

 

Baseline Characteristics of the Patients

 

Table 1 shows the baseline data for the 408 participants. The mean age of all patients is 45 years, and 51% were women. In terms of disease staging, experimental group and control group were comparable. And the baseline outcome including VAS scores and C-SFODI were also reasonably well balanced between experimental group and control group.

 

Table 1 Baseline Characteristics of the Study Participants

Table 1: Baseline characteristics of the study participants.

 

Improvement in the Primary Outcome

 

The changes in the primary outcomes from baseline to six-month followup are shown in Table 2 and Figure 2. Immediately after the intervention, two groups showed significant decrease in VAS than the baseline. And the experimental group showed a more significant decrease than the control group (?16.62 points [95% confidence interval {CI}, ?20.25 to ?12.98]; P < 0.001).

 

Figure 2 Mean Changes of the Primary and Secondary Outcomes

Figure 2: Mean changes of the primary and secondary outcomes. The means of outcomes are shown for the experimental group (diamond) and the control group (squares). Measurements were obtained at baseline (M1), immediately after the last intervention (M2).

 

Table 2 Changes in Primary and Secondary Outcomes

Table 2: Changes in primary and secondary outcomes.

 

One month after intervention, two groups also had significantly greater reduction in VAS than the baseline. And again, the experimental group showed a more significant decrease than the control group (?6.37 points [95% CI, ?10.20 to ?2.54]; P = 0.001).

 

Six months after intervention, compared with the baseline, the changes in VAS remained significant in the experimental group and control group, but between-group difference was not significant (P = 0.091).

 

Improvement in the Secondary Outcome

 

Immediately after intervention, two groups had significant improvement in C-SFODI than the baseline, and the experimental group showed a more significant improvement than the control group (?15.55 points [95% CI, ?18.92 to ?12.18]; P < 0.001).

 

One month after intervention, two groups also had significant improvement in C-SFODI than the baseline. And again, the experimental group improved more (?11.37 points [95% CI, ?14.62 to ?8.11]; P < 0.001).

 

Six months after intervention, two groups also maintained significant improvement, and the experimental group showed superiority (?7.68 points [95% CI, ?11.42 to ?3.94]; P < 0.001).

 

Adverse Events

 

One patient in the experiment group had mild fainting during acupuncture, remission by bed rest, and then completed the remaining treatment. Two patients in the control group were given Fenbid orally due to aggravated low back pain. No other adverse events were noted in either experimental group or control group.

 

Discussion

 

Although the mechanism of low back pain caused by lumbar disc herniation (LDH) is still not very clear, the prevailing view is that low back pain due to LDH was found to occur not only in response to mechanical stimuli but also to chemical irritation around the nerve root sheath and sinuvertebral nerve.

 

Different TCM therapies have different advantages in the treatment of LDH. Pain is the main symptom in the acute stage of LDH; acupuncture has good analgesic effect on low back pain due to LDH. Lumbar dysfunction is the main symptom in the remission stage; Chinese massage has good effect on improving dysfunction. Oral Chinese herbal formulae, external use of Chinese medicine, and Chinese herbal injection also showed good effect in relieving pain and improving dysfunction caused by LDH. And one study also found that Salvia miltiorrhiza injection especially works better and faster for the acute stage when compared with mannitol. Although the mechanism of acupuncture, Chinese massage, and traditional Chinese herbs in the treatment of LDH remains unclear, it is generally agreed that these treatment methods play a role by increasing local blood circulation, relieving nerve root edema, and speeding up the metabolism of the local inflammatory mediators. In recovery stage of the disease, the major task is to strengthen the muscles of the waist and abdomen to prevent relapse, and TCM functional exercise has advantages in this regard and can subsequently increase the lumbar stability to prevent recurrence.

 

Treating LDH according to different stages has been more and more accepted. In China, LDH is mainly divided into three stages, including acute stage, subacute stage (or remission stage), and chronic stage (or recovery stage). Studies have proven that treating LDH according to different stages has obtained a good clinical effect. In addition, studies have also suggested that it can obtain a better effect than treatment without differentiating different stages.

 

The past 20 years of clinical practice have witnessed the safety of the treatment regimens used in this study. At the same time, its efficacy has been preliminarily confirmed; however, high quality research evidence is still needed. In the treatment regimens, different TCM therapies were selected according to the characteristics of different stages. Specifically, acupuncture and Chinese herbal injections were used in the acute stage for fast pain relief, Chinese Tuina (massage) and external application of Chinese medicine were used in the subacute stage for improvement of the lumbar functions, and low back muscle exercise was used in the chronic stage to increase the stability of the spine and prevent relapses.

 

In China, nonsurgical treatment of lumbar disc herniation mainly uses drugs, physical therapy, or TCM treatment. TCM treatment used in the experimental group has been used in clinical routine and is considered to have good clinical efficacy; the efficacy of conservative treatment used in the control group is considered very weak, usually as auxiliary treatment of other therapies. Ethics Committee considers that in order to maximize the protection of the interests of the patients, it is necessary to let the patients have more opportunity to receive TCM treatment, so in this research the sample size of the experimental group and the control group is 3?:?1.

 

The findings of this study have shown that immediately and one month after intervention, integrative TCM conservative treatment can significantly reduce the VAS scores and C-SFODI, and at six month after intervention, integrative TCM conservative treatment can also significantly reduce the C-SFODI, but two groups have no significant difference in reducing VAS score. VAS is an international general pain visual analog scale, and C-SFODI is the improved version of the ODI (Oswestry Disability Index), and it consists of 9 questions, a higher percentage indicating a more severe functional disability.

 

Regarding adverse events, one patient had mild fainting in the experiment group, two patients in the control group were given Fenbid oral due to low back pain aggravation, and no other adverse events were noted in either experimental group or control group. The mechanism of integrative TCM conservative treatment for LDH remains unclear, and it will be our future research orientation.

 

The main limitation of this study is the short followup time. As a result, we failed to conduct comprehensive evaluation regarding the long-term efficacy of integrative TCM conservative treatment for LDH.

 

Conclusions

 

This randomized controlled clinical trial provides reliable evidence regarding the effectiveness of integrative TCM conservative treatment for patients with low back pain due to lumbar disc herniation. A large sample of long-term followup is further needed for future research.

 

Conflict of Interests

 

No potential conflict of interests relevant to this study was reported.

 

Acknowledgments

 

This work is supported by the Key Discipline of TCM Orthopaedic and Traumatic of the Ministry of Education of the People’s Republic of China (100508); the Medical Key Project of Shanghai Science and Technology Commission (09411953400); the project of Shanghai Medical leading talent (041); the National Natural Science Foundation of China (81073114, 81001528); the National Key New Drugs Creation Project, innovative drug research and development technology platform (no. 2012ZX09303009-001); Shanghai University Innovation Team Construction Project of the Spine Disease of Traditional Chinese Medicine (2009-26).

 

In conclusion, with the measured outcomes and final results of the two groups of participants with low back pain due to lumbar disc herniation, the randomized controlled trial helped contribute valuable information regarding the safety and effectiveness, as well as the clinical effect of integrative TCM conservative therapy. 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

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Sciatica

 

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

 

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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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Vertebral Artery Dissection Found During Chiropractic Examination

Vertebral Artery Dissection Found During Chiropractic Examination

Acknowledging the subsequent information below,�approximately more than 2 million people are injured in automobile accidents each year and among those incidents, the majority of the people involved are diagnosed with whiplash and/or neck injury by a healthcare professional. When the complex structure of the neck is subjected to trauma, tissue damage and other medical complications may occur. Vertebral artery dissection, or VAD, is characterized by a flap-like tear on the inner lining of the vertebral artery in charge of supplying blood to the brain. After the tear, blood can then enter the arterial wall and form a blood clot, thickening the artery wall and often impeding blood flow.

 

Through years of experience practicing chiropractic care,�VAD may often follow after trauma to the neck, such as that which occurs in an automobile accident, or whiplash injury. The symptoms of vertebral artery dissection include head and neck pain as well as intermittent or permanent stroke symptoms, such as difficulty speaking, impaired coordination and loss of vision. VAD, or vertebral artery dissection, is generally diagnosed with a contrast-enhanced CT or MRI scan.

 

Abstract

 

A 30-year-old woman presented to an emergency department with sudden onset of transient loss of left peripheral vision. Owing to a history of migraine headaches, she was released with a diagnosis of ocular migraine. Two days later, she sought chiropractic care for the chief symptom of severe neck pain. The chiropractor suspected the possibility of vertebral artery dissection (VAD). No manipulation was performed; instead, MR angiography (MRA) of the neck was obtained, which revealed an acute left VAD with early thrombus formation. The patient was placed on aspirin therapy. Repeat MRA of the neck 3?months later revealed resolution of the thrombus, without progression to stroke. This case illustrates the importance for all healthcare providers who see patients with neck pain and headache to be attentive to the symptomatic presentation of possible VAD in progress.

 

Background

 

Vertebral artery dissection (VAD) leading to stroke is an uncommon but potentially serious disorder. The incidence of stroke related to the vertebrobasilar system varies from 0.75 to 1.12/100?000 person-years. The pathological process in VAD typically involves dissection of the wall of the artery followed sometime later by thrombus formation, which may cause arterial occlusion or may lead to embolisation, causing occlusion of one or more of the distal branches off the vertebral artery, including the basilar artery, which can be catastrophic. VAD typically occurs in patients who have an inherent, transitory weakness in the arterial wall. In at least 80% of cases, the initial symptoms include neck pain with or without headache.

 

Many patients with VAD may in the early stages present to chiropractors seeking relief from neck pain and headache, without realising they are experiencing VAD. In many of these cases, the patient later develops a stroke. Until recently, it was assumed that the dissection (and subsequent stroke) was caused by cervical manipulative therapy (CMT). However, while early studies found an association between visits to a chiropractor and subsequent stroke related to VAD, recent data suggest that this relationship is not causal.

 

This case report is illustrative of the scenario in which a patient with an undiagnosed VAD in evolution consulted a chiropractor for neck pain and headache. After thorough history and examination, the chiropractor suspected VAD and did not perform CMT. Instead, the patient was referred for further evaluation, which detected a VAD in progress. Prompt diagnosis and anticoagulant treatment were thought to have averted progression to a stroke.

 

Case Presentation

 

A 30-year-old otherwise healthy woman consulted a chiropractor (DBF), reporting of right-sided neck pain in the suboccipital region. The patient reported that, 3?days previously, she had gone to the local hospital emergency department (ED) because of the sudden onset of loss of left peripheral vision. The visual symptoms interfered with her ability to see through her left eye; this was accompanied by �numbness� in her left eyelid. About 2?weeks prior to this ED visit, she had experienced an episode of acute left-sided neck pain with severe left-sided headache. She also related a history of migraine headache without prodrome. She was released from the ED with a tentative diagnosis of ocular migraine. She had never been previously diagnosed with ocular migraine, nor had she ever experienced any visual disturbances with her previous migraines.

 

Shortly after the left-sided ocular symptoms resolved, she suddenly developed right-sided neck pain without provocation, for which she sought chiropractic treatment. She also reported a transient episode of right-sided visual disturbance occurring that same day as well. This was described as sudden blurriness that was of short duration and resolved spontaneously earlier in the day of her presentation for chiropractic examination. When she presented for the initial chiropractic examination, she denied current visual disturbance. She said that she was not experiencing any numbness, paraesthesia or motor loss in the upper or lower extremities. She denied ataxia or difficulty with balance. Medical history was remarkable for childbirth 2� months prior to initial presentation. She stated that her migraine headaches were associated with her menstrual cycle. Family history was remarkable for a spontaneous ascending thoracic aortic aneurysm in her older sister, who was about 30?years of age when her aneurysm had occurred.

 

Investigations

 

Based on the history of sudden onset of severe upper cervical pain and headache with visual disturbance and ocular numbness, the DC was concerned about the possibility of early VAD. Urgent MR angiography (MRA) of the neck and head, along with MRI of the head, was ordered. No cervical spine examination or manipulation was performed because of the suspicion that the neck pain was related to VAD rather than to a �mechanical� cervical disorder.

 

MRA of the neck demonstrated that the left vertebral artery was small and irregular in calibre, extending from the C7 level cephalad to C2, consistent with dissection. There was a patent true lumen with a surrounding cuff of T1 hyper-intensity, consistent with dissection with subintimal thrombus within the false lumen (Figures 1 and ?2). MRI of the head with and without contrast, and MRA of the head without contrast, were both unremarkable. Specifically, there was no intracranial extension of dissection or evidence of infarction. MR perfusion of the brain revealed no focal perfusion abnormalities.

 

Figure 1 Axial Proton Density Image - Image 1

Figure 1: Axial proton density image demonstrates circumferential hyper-intensity surrounding the left cervical vertebral artery (representing the false lumen). Note decreased calibre of true lumen (black flow void) with respect to the right vertebral artery.

 

Figure 2 Axial Image from Three Dimensional Time of Flight MRA - Image 2

Figure 2: Axial image from three-dimensional time-of-flight MRA demonstrates T1 hypointense dissection flap separating the true lumen (lateral) from the false lumen (medial). MRA, MR angiography.

 

Differential Diagnosis

 

The ED released the patient with a tentative diagnosis of ocular migraine, due to her history of migraine headaches. However, the patient stated that the left-sided headache was atypical��like nothing I’ve ever experienced before.� Her previous migraines were associated with her menstrual cycle, but not with any vision changes. She had never been previously diagnosed with ocular migraine. MRA of the cervical region revealed that the patient actually had an acute dissection with thrombus formation in the left vertebral artery.

 

Treatment

 

Owing to the potential of impending stroke associated with an acute VAD with thrombus formation, the patient was admitted to the neurology stroke service for close neurological monitoring. During her admission, the patient did not experience any recurrence of neurological deficits and her headaches improved. She was discharged the following day with a diagnosis of left VAD and transient ischaemic attack. She was instructed to avoid vigorous exercise and trauma to the neck. Daily aspirin (325?mg) was prescribed, to be continued for 3�6?months after discharge.

 

Outcome and Follow-Up

 

After discharge from the stroke service, the patient had no recurrence of headache or visual disturbances, and her posterior neck pain symptoms resolved. Repeat imaging was performed 3?months after presentation, which demonstrated improved calibre of the cervical left vertebral artery with resolution of the thrombus within the false lumen (Figure 3). Imaging of the intracranial compartment remained normal, without evidence of interval infarction or perfusion asymmetry.

 

Figure 3 Maximum Intensity Projection MIP Images - Image 3

Figure 3: Maximum intensity projection (MIP) images from three-dimensional time-of-flight MRA (left image is at time of presentation and right image is at 3-month follow-up). The initial imaging demonstrates markedly diminutive calibre of the left vertebral artery

 

Discussion

 

The pathophysiological process of VAD is thought to start with degeneration of the tissues at the medial-adventitial border of the vertebral artery, leading to the development of microhaematomata within the wall of the artery and, eventually, arterial tear. This can lead to leakage of blood into the arterial wall, causing occlusion of the lumen with subsequent thrombus formation and embolisation, resulting in stroke related to one of the branches of the vertebral artery. This pathological process is similar to that of spontaneous carotid artery dissection, spontaneous thoracic aortic dissection and spontaneous coronary artery dissection. All these conditions tend to occur in younger adults and some have speculated that they may be part of a common inherited pathophysiological process. Notable in this case is the fact that the patient’s older sister had experienced a spontaneous thoracic aortic aneurysm (probably a dissection) at around the same age (30?years) as this patient was when she experienced her VAD.

 

While the dissection is often sudden, the luminal compromise and complications of VAD can develop gradually leading to variable symptoms and presentation, depending on the stage of the disease. The dissection itself, which develops some time before the onset of neural ischaemia, can cause stimulation of nociceptive receptors within the artery, producing pain that is most commonly felt in the upper cervical spine or head. Only after the pathophysiological process progresses to the point of complete arterial occlusion or thrombus formation with distal embolisation does the full manifestation of infarction occur. However, as illustrated in this case, neurological symptoms can develop early in the process, particularly in cases in which the true lumen demonstrates significant calibre decrease secondary to compression.

 

There are several interesting aspects to this case. First, it highlights the importance of spine clinicians being alert to the possibility that what may appear to be typical �mechanical� neck pain could be something potentially more sinister, such as VAD. The sudden onset of severe suboccipital pain, with or without headache, and accompanying brainstem related neurological symptoms, should alert the clinician to the possibility of VAD. As in the case reported here, patients with a history of migraine will typically describe the headache as different from their usual migraine. A careful neurological examination should be performed, looking for possible subtle neurological deficits, although the neurological examination will often be negative in the early stages of VAD.

 

Second, a triad of symptoms raised concern that the patient might be experiencing a VAD in progress. The symptom triad included: (1) spontaneous onset of severe upper cervical pain; (2) severe headache that was distinctly different from the patient’s usual migraine headaches; and (3) brainstem-related neurological symptoms (in the form of transient visual disturbance). Notably, careful neurological examination was negative. Nonetheless, the history was of sufficient concern to prompt immediate investigation.

 

When VAD is suspected but no frank signs of stroke are present, immediate vascular imaging is indicated. While the optimal imaging evaluation of VAD remains controversial, MRA or CTA are the diagnostic studies of choice given their excellent anatomic delineation and ability to evaluate for complications (including infarction and changes in brain perfusion). Some advocate the use of Doppler ultrasound; however, it has limited utility given the course of the vertebral artery in the neck and limited evaluation of the vertebral arteries cephalad to the origin. Additionally, ultrasound imaging is unlikely to allow visualisation of the dissection itself and thus can be negative in the absence of significant arterial occlusion.

 

Third, this case is interesting in light of the controversy about cervical manipulation as a potential �cause� of VAD. While case reports have presented patients who have experienced stroke related to VAD after cervical manipulation, and case�control studies have found a statistical association between visits to chiropractors and stroke related to VAD, further investigation has indicated that the association is not causal. Cassidy et al found that a patient who experiences stroke related to VAD is just as likely to have visited a primary care practitioner as to have visited a chiropractor prior to having the stroke. The authors suggested that the most likely explanation for the statistical association between visits to chiropractors and subsequent VAD is that a patient who experiences the initial symptoms of VAD (neck pain with or without headache) seeks medical attention for these symptoms (from a chiropractor, primary care practitioner, or another type of practitioner), then subsequently experiences the stroke, independent of any action taken by the practitioner.

 

It is important to note that, while there have been reported cases of carotid artery dissection after cervical manipulation, case�control studies have not found this association. The initial symptoms of carotid dissection (neurological symptoms, with neck and head pain less common than VAD), aortic dissection (sudden onset of severe, �tearing� pain) and coronary artery dissection (acute severe chest pain, ventricular fibrillation) are likely to cause the individual to immediately seek ED care, rather than seek chiropractic care. However, VAD has seemingly benign initial symptoms�neck pain and headache�which are symptoms that commonly cause patients to seek out chiropractic care. This may explain why only VAD is associated with visits to chiropractors, while these other types of dissections are not; patients with these other conditions, which have much more alarming symptoms, simply do not present to chiropractors.

 

This case is a good example of a patient with VAD in progress presenting to a chiropractor for the purpose of seeking relief from neck pain. Fortunately, the chiropractor was astute enough to ascertain that the patient’s symptoms were not suggestive of a �mechanical� cervical spine disorder, and appropriate diagnostic investigation was performed. However, if manipulation had been performed, the VAD that was already in progress from natural history may have been blamed on manipulation, after being detected on MRA imaging. Fortunately, in this case, the chiropractor was able to assist with early detection and treatment, and subsequently a stroke was likely averted.

 

Learning Points

 

  • A case is presented in which a patient saw a chiropractor, while seeking treatment for neck pain, and the history raised concern for possible vertebral artery dissection (VAD).
  • Rather than providing manipulative treatment, the chiropractor referred the patient for advanced imaging, which confirmed the diagnosis of VAD.
  • The case illustrates the importance of paying attention to subtle historical factors in patients with VAD.
  • It also serves as an example of a patient with a VAD in progress seeking the services of a chiropractor for the initial symptoms of the disorder.
  • In this case, early detection of the dissection occurred and the patient had a full recovery without any subsequent stroke.

 

Acknowledgments

 

The authors would like to acknowledge the assistance of Pierre Cote, DC, PhD, for his assistance with reviewing this manuscript.

 

Footnotes

 

Contributors: All the authors acknowledge that they have contributed the following to the submission of this manuscript: conception and design, drafting of the manuscript, critical revisions of the manuscript, literature review and references, and proof reading of the final manuscript.

 

Competing interests: None declared.

 

Patient consent: Obtained.

 

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

 

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 .

 

Cited by Dr. Alex Jimenez

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Wellness

 

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

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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17.�Bendick PJ, Jackson VP.�Evaluation of the vertebral arteries with duplex sonography.�J Vasc Surg1986;3:523�30.�doi:10.1016/0741-5214(86)90120-5[PubMed]
18.�Murphy DR.�Current understanding of the relationship between cervical manipulation and stroke: what does it mean for the chiropractic profession?Chiropr Osteopat�2010;18:22�doi:10.1186/1746-1340-18-22[PMC free article][PubMed]
19.�Engelter ST, Grond-Ginsbach C, Metso TM et al.�Cervical artery dissection: trauma and other potential mechanical trigger events.�Neurology�2013;80:1950�7.�doi:10.1212/WNL.0b013e318293e2eb[PubMed]
20.�Peters M, Bohl J, Th�mke F et al.�Dissection of the internal carotid artery after chiropractic manipulation of the neck.�Neurology�1995;45:2284�6.�doi:10.1212/WNL.45.12.2284[PubMed]
21.�Nadgir RN, Loevner LA, Ahmed T et al.�Simultaneous bilateral internal carotid and vertebral artery dissection following chiropractic manipulation: case report and review of the literature.�Neuroradiology2003;45:311�14.�doi:10.1007/s00234-003-0944-x[PubMed]
22.�Dittrich R, Rohsbach D, Heidbreder A et al.�Mild mechanical traumas are possible risk factors for cervical artery dissection.�Cerebrovasc Dis�2007;23:275�81.�doi:10.1159/000098327[PubMed]
23.�Chung CL, Cote P, Stern P et al.�The association between cervical spine manipulation and carotid artery dissection: a systematic review of the literature.�J Manipulative Physiol Ther�2014; doi:10.1016/j.jmpt.2013.09.005�doi:10.1016/j.jmpt.2013.09.005[PubMed]
24.�Thomas LC, Rivett DA, Attia JR et al.�Risk factors and clinical features of craniocervical arterial dissection.�Man Ther�2011;16:351�6.�doi:10.1016/j.math.2010.12.008[PubMed]
25.�Klineberg E, Mazanec D, Orr D et al.�Masquerade: medical causes of back pain.�Cleve Clin J Med2007;74:905�13.�doi:10.3949/ccjm.74.12.905[PubMed]
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What are Case Reports & Case Series?

What are Case Reports & Case Series?

The diagnosis of a variety of diseases has been effectively determined through clinical and experimental data. Research studies provide valuable information on the pathogenesis of many conditions and are often the primary source of information regarding new diseases or conditions. Case reports and case series are first level research studies, offering the most initial insights on a particular health issue through the personal experience of one or more people with a disease or condition. The following article describes the purpose of case reports and case series, and how they provide clinical and experimental data.

 

Learning Objectives

 

1. Case reports and case series describe the experience of one or more people with a disease.
2. Case reports and case series are often the first data alerting to a new disease or condition.
3. Case reports and case series have specific limitations:

  • a. Lack of a denominator to calculate rates of disease
  • b. Lack of a comparison group
  • c. Selecting study populations
  • d. Sampling variation

 

Case Reports and Case Series

 

Case reports and case series represent the most basic type of study design, in which researchers describe the experience of a single person (case report) or a group of people (case series). Typically, case reports and case series describe individuals who develop a particular new disease or condition. Case reports and case series can provide compelling reading because they present a detailed account of the clinical experience of individual study subjects. In contrast, studies that evaluate large numbers of individuals typically summarize the data using statistical measures, such as means and proportions.

 

Example 3.1. A case series describes 15 young women who develop breast cancer; 9 of these women report at least once weekly ingestion of foods packaged with the estrogenic chemical bisphenol A (BPA). Urine testing confirms the presence of BPA among all nine case women.

 

It is tempting to surmise from these data that BPA might be causally related to breast cancer. However, case reports/case series have important limitations that preclude inference of a causal relationship.

First, case reports/case series lack denominator data that are necessary to calculate the rate of disease. The denominator refers to the population from which the diseased subjects arose. For example, to calculate the incidence proportion or incidence rate of breast cancer among women exposed to BPA, the total number of women who were exposed to BPA or the total number of person-years at risk is needed.

 

Table 1 - Incidence Proportion & Incidence Rate

 

Disease rates are needed for comparison with historically reported disease rates, or with rates from a selected comparison group. Unfortunately, obtaining the necessary denominator data may not be easy. In this example, additional data sources are needed to determine the total number of BPA-exposed women from whom the breast cancer cases arose. The case series data alone cannot be used to calculate the rate of breast cancer because they do not include the total number of women who were exposed to BPA.

 

A second problem with case report/case series report data is the lack of a comparison group. The 60% prevalence of BPA exposure among women with breast cancer seems unusually high, but what is prevalence of BPA exposure among women without breast cancer? This comparison is critical for addressing the hypothesis that BPA might be a cause of breast cancer.

 

A third limitation of case reports/case series is that these studies often describe highly select individuals who may not represent the general population. For example, it is possible that the 15 breast cancer cases originated from a single hospital in a community with high levels of air pollution or other potential carcinogens. Under these conditions, a fair estimate of breast cancer incidence among non-BPA exposed women from the same community would be required to make an inference that BPA causes breast cancer.

 

A fourth limitation of case reports/case series is sampling variation. This concept will be explored in detail later in this book. The basic idea is that there is tremendous natural variation in disease development in humans. The fact that 9 of 15 women with breast cancer reported BPA exposure is interesting; however, this number may be very different in the next case series of 15 women with breast cancer simply due to chance. A precise estimate of the rate of a disease, independent from chance, can be obtained only by increasing the number of diseased subjects.

 

Recall the list of factors that are used to judge whether a factor may be a cause of disease:

 

1. Randomized evidence
2. Strength of association
3. Temporal relationship between exposure and outcome
4. Dose-response association
5. Biological plausibility

 

In general, case reports/case series rely almost exclusively on biological plausibility to make their case for causation. For the BPA and breast cancer case series, there is no randomized evidence, no measure of the strength of association between BPA and breast cancer, no reported dose�response association, and no evidence that BPA exposure preceded the development of breast cancer. The inference for causation derives completely from previous biological knowledge regarding the estrogenic effects of BPA.

 

Despite limitations of case series data, they may be highly suggestive of an important new association, disease process, or unintended side effect of a medication or treatment.

 

Example 3.2. In 2007, a case series described three cases of male prepubertal gynecomastia. The report included detailed information on each subjects� age, body size, serum levels of endogenous steroids, and known exposures to exogenous hormones. It was discovered that all three otherwise healthy boys had been exposed to some product containing lavender oil (lotion, shampoo, soap), and that in each case, the gynecomastia resolved upon discontinuation of the product. Subsequent in vitro studies demonstrated endocrine-disrupting activity of lavender oil. This novel case series data may lead to further investigations to determine whether lavender oil, a common ingredient in commercially available products, may be a cause of gynecomastia.

 

Example 3.3. A vaccine designed to prevent rotavirus infection was found to cause weakening of the intestinal muscle layers in animals. Following release of the vaccine, a number of cases of intussusception (when one portion of the bowel slides into the next) were reported in children who received the vaccine, with some fatal cases. The strong biological plausibility underlying this initial association, and knowledge that intussusception is otherwise rare in infants, was highly suggestive of a causal relationship and the vaccine was removed from the market.

 

Information referenced from B. Kestenbaum, Epidemiology and Biostatistics: An Introduction to Clinical Research, DOI 10.1007/978-0-387-88433-2_3, � Springer Science+Business Media, LLC 2009. 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 .

 

Referenced by Dr. Alex Jimenez

 

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Additional Topics: Wellness

 

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

 

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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

Management of Sciatica: Nonsurgical & Surgical Therapies

Management of Sciatica: Nonsurgical & Surgical Therapies

Consider the following, sciatica is a medical term used to describe a collective group of symptoms resulting from the irritation or compression of the sciatic nerve, generally due to an injury or aggravated condition. Sciatica is commonly characterized by radiating pain along the sciatic nerve, which runs down one or both legs from the lower back. The following case vignette discusses Mr. Winston’s medical condition, a 50-year-old bus driver who reported experiencing chronic, lower back and leg pain associated with sciatica during a 4-week time period. Ramya Ramaswami, M.B., B.S., M.P.H., Zoher Ghogawala, M.D., and James N. Weinstein, D.O., provide a comprehensive analysis of the various treatment options available to treat sciatica, including undergoing lumbar disk surgery and receiving nonsurgical therapy.

 

On a personal note, as a practicing doctor of chiropractic, choosing the correct treatment care for any type of injury or condition can be a personal and difficult decision. If the circumstances are favorable, the patient may determine what is the best form of treatment for their type of medical issue. While nonsurgical therapies, such as chiropractic care, can often be utilized to improve symptoms of sciatica, more severe cases of sciatica may require surgical interventions to treat the source of the issue. In most cases, nonsurgical therapies should be considered first, before turning to surgical therapies for sciatica.

 

Case Vignette

 

A Man with Sciatica Who is Considering Lumbar Disk Surgery

 

Ramya Ramaswami, M.B., B.S., M.P.H.

 

Mr. Winston, a 50-year-old bus driver, presented to your office with a 4-week history of pain in his left leg and lower back. He described a combination of severe sharp and dull pain that originated in his left buttock and radiated to the dorsolateral aspect of his left thigh, as well as vague aching over the lower lumbar spine. On examination, passive raising of his left leg off the table to 45 degrees caused severe pain that simulated his main symptom, and the pain was so severe that you could not lift his leg further. There was no leg or foot weakness. His body-mass index (the weight in kilograms divided by the square of the height in meters) was 35, and he had mild chronic obstructive pulmonary disease as a result of smoking one pack of cigarettes every day for 22 years. Mr. Winston had taken a leave of absence from his work because of his symptoms. You prescribed 150 mg of pregabalin per day, which was gradually increased to 600 mg daily because the symptoms had not abated.

 

Now, 10 weeks after the initial onset of his symptoms, he returns for an evaluation. The medication has provided minimal alleviation of his sciatic pain. He has to return to work and is concerned about his ability to complete his duties at his job. He undergoes magnetic resonance imaging, which shows a herniated disk on the left side at the L4�L5 root. You discuss options for the next steps in managing his sciatica. He is uncertain about invasive procedures such as lumbar disk surgery but feels limited by his symptoms of pain.

 

Treatment Options

 

Which of the following would you recommend for Mr. Winston?

 

  1. Undergo lumbar disk surgery.
  2. Receive nonsurgical therapy.

 

To aid in your decision making, each of these approaches is defended in a short essay by an expert in the field. Given your knowledge of the patient and the points made by the experts, which option would you choose?

 

Option 1: Undergo Lumbar Disk Surgery
Option 2: Receive Nonsurgical Therapy

 

1. Undergo Lumbar Disk Surgery

 

Zoher Ghogawala, M.D.

 

Mr. Winston�s case represents a common scenario in the management of symptomatic lumbar disk herniation. In this particular case, the patient�s symptoms and the physical examination are consistent with nerve-root compression and inflammation directly from an L4�L5 herniated disk on his left side. The patient does not have weakness but has ongoing pain and has been unable to work for the past 10 weeks despite receiving pregabalin. Two questions emerge: first, does lumbar disk surgery (microdiskectomy) provide outcomes that are superior to those with continued nonoperative therapy in patients with more than 6 weeks of symptoms; and second, does lumbar microdiskectomy improve the likelihood of return to work in patients with these symptoms?

 

The highest quality data on the topic come from the Spine Patient Outcomes Research Trial (SPORT). The results of the randomized, controlled trial are difficult to interpret because adherence to the assigned treatment strategy was suboptimal. Only half the patients who were randomly assigned to the surgery group actually underwent surgery within 3 months after enrollment, and 30% of the patients assigned to nonoperative treatment chose to cross over to the surgical group. In this study, the patients who underwent surgery had greater improvements in validated patient-reported outcomes. The treatment effect of microdiskectomy was superior to that of nonoperative treatment at 3 months, 1 year, and 2 years. Moreover, in an as-treated analysis, the outcomes among patients who underwent surgery were superior to those among patients who received nonoperative therapy. Overall, the results of SPORT support the use of microdiskectomy in this case.

 

Results of clinical trials are based on a comparison of treatment options in study populations and may or may not apply to individual patients. SPORT did not specify what type of nonoperative therapy was to be used. Physical therapy was used in 73% of the patients, epidural injections in 50%, and medical therapies (e.g., nonsteroidal antiinflammatory drugs) in more than 50%. In the case of Mr. Winston, pregabalin has been tried, but physical therapy and epidural glucocorticoid injections have not been attempted. Despite widespread use of physical therapy for the treatment of lumbar disk herniation, the evidence supporting its effectiveness is inconclusive, according to published guidelines of the North American Spine Society. On the other hand, there is evidence that transforaminal epidural glucocorticoid injection provides short-term relief (30 days) in patients with nerve-root symptoms directly related to a herniated disk. Overall, there is evidence, from SPORT and from a randomized trial from the Netherlands published in the Journal, that early surgery between 6 and 12 weeks after the onset of symptoms provides greater alleviation of leg pain and better overall pain relief than prolonged conservative therapy.

 

The ability to return to work has not been formally studied in comparisons of operative with nonoperative treatments for lumbar disk herniation. Registry data from the NeuroPoint-SD study showed that more than 80% of the patients who were working before disk herniation returned to work after surgery. The ability to return to work may be dependent on the type of vocation, since patients who are manual laborers may need more time to recover to reduce the risk of reherniation.

 

It is well recognized that many patients who have a symptomatic lumbar disk herniation will have improvement spontaneously over several months. Surgery can alleviate symptoms more quickly by immediately removing the offending disk herniation from the affected nerve root. The risk�benefit equation will vary among individual patients. In the case of Mr. Winston, obesity and mild pulmonary disease might increase the risk of complications from surgery, although in SPORT, 95% of surgical patients did not have any operative or postoperative complication. For Mr. Winston, a patient with pain that has persisted for more than 6 weeks, microdiskectomy is a rational option that is supported by high-quality evidence.

 

2. Receive Nonsurgical Therapy

 

James N. Weinstein, D.O.

 

This case involves a common presentation of low back pain radiating to the buttock and posterolateral thigh that might represent either referred mechanical pain or radiculopathy. Classic radiculopathy resulting from compression of a lower lumbar nerve root (L4, L5, or S1) results in pain that radiates distal to the knee and is often accompanied by weakness or numbness in the respective myotome or dermatome. In this case, the pain is proximal to the knee and is not associated with weakness or numbness. In SPORT, surgery resulted in faster recovery and a greater degree of improvement than nonoperative treatment in patients with pain that radiated distal to the knee and was accompanied by neurologic signs or symptoms. However, since Mr. Winston would not have met the inclusion criteria for SPORT, the results of diskectomy in this case would be somewhat unpredictable. He does not have radiculopathy that radiates below the knee, and he does not have weakness or numbness; nonoperative treatment should be exhausted before any consideration of a surgical procedure that in most cases has not been shown to be effective in patients with this type of presentation. In this issue of the Journal, Mathieson and colleagues report the results of a randomized, controlled trial that showed that pregabalin did not significantly alleviate pain related to sciatica. Mr. Winston has been treated only with pregabalin; therefore, other conservative options should be explored.

 

Saal and Saal reported that more than 80% of patients with radiculopathy associated with a lumbar disk herniation had improvement in a matter of months with exercise-based physical therapy. In the nonoperative SPORT cohort, patients had significant improvement from baseline, and approximately 60% of those with classic radiculopathy who initially received nonoperative treatment avoided surgery. Mr. Winston has had minimal treatment and has had symptoms for only 10 weeks. He should undergo a course of exercise-based physical therapy and a trial of a nonsteroidal antiinflammatory medication and may consider a lumbar epidural glucocorticoid injection. Although there is little evidence of the effectiveness of these nonoperative options alone, the combination of these treatments and the benign natural history of the patient�s condition could result in alleviation or resolution of symptoms. If these interventions � and time � do not resolve his symptoms, surgery could be considered as a final option, but it may not have long-term effectiveness and could in and of itself cause the possibility of more harm than good. Mr. Winston has risk factors, such as obesity and a history of smoking, that have been shown to contribute to poor surgical outcomes of certain spinal procedures.

 

Mr. Winston has symptoms of back pain that interfere with his quality of life. He would need to understand, through shared decision making, that a nonsurgical approach is likely to be more effective than surgery over time.

 

Information referenced from the National Center for Biotechnology Information (NCBI) and the New England Journal of Medicine (NEJM). 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 .

 

Cited by Dr. Alex Jimenez

 

Green-Call-Now-Button-24H-150x150-2-3.png

 

Additional Topics: Wellness

 

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

 

blog picture of cartoon paperboy big news

 

IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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References

 

  • 1. Weinstein JN, Tosteson TD, Lurie JD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial. JAMA 2006;296:24412450

  • 2. Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT) observational cohort. JAMA 2006;296:24512459

  • 3. Kreiner DS, Hwang SW, Easa JE, et al. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J 2014;14:180191

  • 4. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med 2010;11:11491168

  • 5. Peul WC, van Houwelingen HC, van den Hout WB, et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 2007;356:22452256

  • 6. Ghogawala Z, Shaffrey CI, Asher AL, et al. The efficacy of lumbar discectomy and single-level fusion for spondylolisthesis: results from the NeuroPoint-SD registry: clinical article. J Neurosurg Spine 2013;19:555563

  • 7. Deyo RA, Weinstein JN. Low back pain. N Engl J Med 2001;344:363370

  • 8. Lurie JD, Tosteson TD, Tosteson AN, et al. Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial. Spine (Phila Pa 1976) 2014;39:316

  • 9. Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med 2017;376:11111120

  • 10. Saal JA, Saal JS. Nonoperative treatment of herniated lumbar intervertebral disc with radiculopathy: an outcome study. Spine (Phila Pa 1976) 1989;14:431437

  • 11. Pinto RZ, Maher CG, Ferreira ML, et al. Drugs for relief of pain in patients with sciatica: systematic review and meta-analysis. BMJ 2012;344:e497e497

  • 12. Pearson A, Lurie J, Tosteson T, et al. Who should have surgery for an intervertebral disc herniation? Comparative effectiveness evidence from the Spine Patient Outcomes Research Trial. Spine 2012;37:140149

  • 13. Weeks WB, Weinstein JN. Patient-reported data can help people make better health care choices. Harvard Business Review. September 21, 2015

 

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