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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic Spinal Manipulative Therapy | Experimental |
| |
| Usual Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic Spinal Manipulative Therapy | Other | Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recruitment of eligible patients | The number of patients recruited per week for 19 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul B Bishop, DC, MD, PhD | Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| D012585 | Sciatica |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |
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| Usual Care | Other | Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline. |
|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |