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

Vancouver General Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Acute Sciatica Lumbar Disc Herniation

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Rate of recruitment of eligible patients

Time frame: The number of patients recruited per week for 19 months

Secondary Outcomes

Cytokine and cytokine mRNA levels in serum.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Specimens will be harvested an average of 6 weeks post-randomization

Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.

Time frame: Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.

mRDQ and VAS

Time frame: Change from baseline and pre-surgery or following a 4-week course of CSMT

mRMQ and VAS

Time frame: Change from baseline and 12 weeks post-surgery and/or post-CSMT