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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552486
First Posted: March 13, 2012
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Paul Bishop, Vancouver General Hospital
  Purpose
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.

Condition Intervention
Acute Sciatica Lumbar Disc Herniation Other: Chiropractic Spinal Manipulative Therapy Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Dr. Paul Bishop, Vancouver General Hospital:

Primary Outcome Measures:
  • Rate of recruitment of eligible patients [ Time Frame: The number of patients recruited per week for 19 months ]

Secondary Outcome Measures:
  • 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). ]
  • 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. ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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. ]
  • mRDQ and VAS [ Time Frame: 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 ]
  • mRDQ and VAS [ Time Frame: Change from baseline and 24 weeks post-surgery and/or post-CSMT ]

Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chiropractic Spinal Manipulative Therapy Other: Chiropractic Spinal Manipulative Therapy
Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
Usual Care 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552486


Locations
Canada, British Columbia
Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver General Hospital
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
  More Information

Responsible Party: Dr. Paul Bishop, Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia, Vancouver General Hospital
ClinicalTrials.gov Identifier: NCT01552486     History of Changes
Other Study ID Numbers: 1R21AT006773-01A1 ( U.S. NIH Grant/Contract )
First Submitted: February 29, 2012
First Posted: March 13, 2012
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Dr. Paul Bishop, Vancouver General Hospital:
chiropractic
manipulation
radiculopathy
sciatica
lumbar
disc
herniation
protrusion

Additional relevant MeSH terms:
Radiculopathy
Hernia
Sciatica
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Neuralgia
Pain
Neurologic Manifestations
Sciatic Neuropathy
Mononeuropathies
Signs and Symptoms