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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

Page last updated: August 23, 2015

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