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

November 2, 2016 updated by: Dr. Paul Bishop, Vancouver General Hospital

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
EXPERIMENTAL: Chiropractic Spinal Manipulative Therapy
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of recruitment of eligible patients
Time Frame: The number of patients recruited per week for 19 months
The number of patients recruited per week for 19 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
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.
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
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
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
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.
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
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
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
Change from baseline and 24 weeks post-surgery and/or post-CSMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul B Bishop, DC, MD, PhD, Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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