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

Not Applicable

• Conditions: Acute Sciatica; Lumbar Disc Herniation
• Interventions: Other: Chiropractic Spinal Manipulative Therapy; Other: Usual Care

• Registration Number: NCT01552486
• Lead Sponsor: Vancouver General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-03-08
• Study First Posted: 2012-03-13
• Study Start: 2012-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chiropractic Spinal Manipulative Therapy	Chiropractic Spinal Manipulative Therapy	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Rate of recruitment of eligible patients	The number of patients recruited per week for 19 months

Secondary Outcome Measures

Name	Time	Method
mRDQ and VAS	Change from baseline 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.	Specimens will be harvested an average of 6 weeks post-randomization
mRMQ and VAS	Change from baseline and 12 weeks post-surgery and/or post-CSMT
Cytokine and cytokine mRNA levels in serum.	Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT
Cytokine and cytokine mRNA levels in serum	Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT
Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.	Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.

Trial Locations

Locations (1)

Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada