Overview

This trial is active, not recruiting.

Conditions acute sciatica, lumbar disc herniation
Treatments chiropractic spinal manipulative therapy, usual care
Sponsor Vancouver General Hospital
Start date June 2012
End date June 2017
Trial size 40 participants
Trial identifier NCT01552486, 1R21AT006773-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
chiropractic spinal manipulative therapy
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
(Other)
usual care
Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.

Primary Outcomes

Measure
Rate of recruitment of eligible patients
time frame: The number of patients recruited per week for 19 months

Secondary Outcomes

Measure
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
mRDQ and VAS
time frame: Change from baseline and 24 weeks post-surgery and/or post-CSMT

Eligibility Criteria

Male or female participants from 19 years up to 60 years old.

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).

Additional Information

Official title 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
Principal investigator Paul B Bishop, DC, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vancouver General Hospital.