Acute Sciatica, Lumbar Disc Herniation
Conditions
Keywords
chiropractic, manipulation, radiculopathy, sciatica, lumbar, disc, herniation, protrusion
Brief summary
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.
Interventions
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
OTHERUsual Care
Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.
Sponsors
Vancouver General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of recruitment of eligible patients | The number of patients recruited per week for 19 months |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| 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 |
| 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). |
| 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 |
| 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. |
Countries
Canada
Outcome results
None listed