Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation

Study Overview
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Brief Summary
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Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the modulation of in vivo inflammatory mediators. This feasibility study will define the key experimental variables required to conduct a large multicentre study that will clarify the biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.

Official Title
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Biology and Clinical Outcomes of Chiropractic Spinal Manipulative Therapy in the Treatment of Patients With Acute Inflammatory Radiculopathy Secondary to Lumbar Disc Herniation: a Pilot Study

Conditions
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Acute Sciatica, Lumbar Disc Herniation

Intervention / Treatment
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* Other: Chiropractic Spinal Manipulative Therapy
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chief complaint of sciatica rather than lower back pain pain of up to 6 months' duration a McCulloch criteria score of 5/5 (two clinical symptoms and two clinical signs of sciatica, and diagnostic imaging confirming the presence of a herniated nucleus pulposus contacting a spinal nerve root at the appropriate level) fluency in spoken and written English to ensure subjects understand the content of questionnaires and consent Exclusion Criteria: progressive neurological deficit spinal fracture spinal tumor spinal infection spinal nerve root motor score of less than 4/5 spinal stenosis that is not attributable to a herniated disc any other significant spinal ailment or local or generalized co-morbidity ailment that could affect outcomes independently of SMT ( e.g. seronegative spondyloarthropathy, malignancy).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chiropractic Spinal Manipulative Therapy<br> | Other: Chiropractic Spinal Manipulative Therapy<br>* Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.<br>|
| Other: Usual Care<br> | Other: Usual Care<br>* Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recruitment of eligible patients |  | The number of patients recruited per week for 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine and cytokine mRNA levels in serum. |  | Change from baseline cytokine and cytokine mRNA levels in serum 4 weeks prior to surgery or commencing chiropractic spinal manipulative therapy (CSMT). | 
| Cytokine and cytokine mRNA levels in serum |  | Change from baseline cytokine and mRNA levels in serum pre-surgery or following a 4-week course of CSMT. | 
| Cytokine and cytokine mRNA levels in serum |  | Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT | 
| Cytokine and cytokine mRNA levels in serum. |  | Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT | 
| Total mRNA levels (isolated from disc tissue and disc / periradicular lavage samples) of interleukins 1,10 and 11, MIP-1 beta TNF alpha, and chemotactic protein alpha. |  | Specimens will be harvested an average of 6 weeks post-randomization | 
| Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale. |  | Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT. | 
| mRDQ and VAS |  | Change from baseline and pre-surgery or following a 4-week course of CSMT | 
| mRMQ and VAS |  | Change from baseline and 12 weeks post-surgery and/or post-CSMT | 
| mRDQ and VAS |  | Change from baseline and 24 weeks post-surgery and/or post-CSMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manipulation, radiculopathy, sciatica, disc, herniation, protrusion, chiropractic, lumbar