Clinical trial NCT01552486: Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Sciatica
Lumbar Disc Herniation
Keywords: chiropractic
manipulation
radiculopathy
sciatica
lumbar
disc
herniation
protrusion
Lead sponsor: Vancouver General Hospital
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of recruitment of eligible patients
timeFrame: The number of patients recruited per week for 19 months
Secondary outcomes:
measure: Cytokine and cytokine mRNA levels in serum.
timeFrame: Change from baseline cytokine and cytokine mRNA levels in serum 4 weeks prior to surgery or commencing chiropractic spinal manipulative therapy (CSMT).
measure: Cytokine and cytokine mRNA levels in serum
timeFrame: Change from baseline cytokine and mRNA levels in serum pre-surgery or following a 4-week course of CSMT.
measure: Cytokine and cytokine mRNA levels in serum
timeFrame: Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT
measure: Cytokine and cytokine mRNA levels in serum.
timeFrame: Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT
measure: 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.
timeFrame: Specimens will be harvested an average of 6 weeks post-randomization
measure: Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.
timeFrame: Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.
measure: mRDQ and VAS
timeFrame: Change from baseline and pre-surgery or following a 4-week course of CSMT
measure: mRMQ and VAS
timeFrame: Change from baseline and 12 weeks post-surgery and/or post-CSMT
measure: mRDQ and VAS
timeFrame: Change from baseline and 24 weeks post-surgery and/or post-CSMT
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia
name: Paul B Bishop, DC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: