Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation
Information source: Vancouver General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Sciatica; Lumbar Disc Herniation
Intervention: Chiropractic Spinal Manipulative Therapy (Other); Usual Care (Other)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Vancouver General Hospital Official(s) and/or principal investigator(s): Paul B Bishop, DC, MD, PhD, Principal Investigator, Affiliation: Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia
Overall contact: Paul B Bishop, DC, MD, PhD, Phone: 604-875-4549, Email: Paul.Bishop@vch.ca
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Primary outcome: Rate of recruitment of eligible patients
Secondary outcome: Cytokine and cytokine mRNA levels in serum.Cytokine and cytokine mRNA levels in serum Cytokine and cytokine mRNA levels in serum Cytokine and cytokine mRNA levels in serum. 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. Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale. mRDQ and VAS mRMQ and VAS mRDQ and VAS
Eligibility
Minimum age: 19 Years.
Maximum age: 60 Years.
Gender(s): Both.
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).
Locations and Contacts
Paul B Bishop, DC, MD, PhD, Phone: 604-875-4549, Email: Paul.Bishop@vch.ca
Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital, Vancouver, British Columbia V5Z 1M9, Canada; Not yet recruiting Paul B Bishop, DC, MD, PhD, Principal Investigator
Additional Information
Starting date: June 2012
Last updated: March 8, 2012
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