Chiropractic Spinal Manipulative Therapy for Acute Sciatica Secondary to Lumbar Disc Herniation - Full Text View

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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (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:

MedlinePlus related topics: Hernia Sciatica

U.S. FDA Resources

Further study details as provided by Vancouver General Hospital:

Primary Outcome Measures:

Rate of recruitment of eligible patients [ Time Frame: The number of patients recruited per week for 19 months ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
mRDQ and VAS [ Time Frame: Change from baseline and pre-surgery or following a 4-week course of CSMT ] [ Designated as safety issue: No ]
mRMQ and VAS [ Time Frame: Change from baseline and 12 weeks post-surgery and/or post-CSMT ] [ Designated as safety issue: No ]
mRDQ and VAS [ Time Frame: Change from baseline and 24 weeks post-surgery and/or post-CSMT ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	May 2014 (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

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552486

Contacts

Contact: Paul B Bishop, DC, MD, PhD

604-875-4549

Paul.Bishop@vch.ca

Locations

Canada, British Columbia
Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital	Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Principal Investigator: Paul B Bishop, DC, MD, PhD

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

No publications provided

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
Study First Received:	February 29, 2012
Last Updated:	March 8, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Vancouver General Hospital:

chiropractic
manipulation
radiculopathy
sciatica

lumbar
disc
herniation
protrusion

Additional relevant MeSH terms:

Hernia
Sciatica
Intervertebral Disk Displacement
Radiculopathy
Pathological Conditions, Anatomical
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases

Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 17, 2013