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

NCT01552486 | Unknown DMC

• 1 other identifier: 1R21AT006773-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Sciatica; Lumbar Disc Herniation

Keywords

chiropractic; manipulation; radiculopathy; sciatica; lumbar; disc; herniation; protrusion

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment of eligible patients

  The number of patients recruited per week for 19 months

Secondary Outcomes (9)

• Cytokine and cytokine mRNA levels in serum.

  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

  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

  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.

  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.

  Specimens will be harvested an average of 6 weeks post-randomization

Study Arms (2)

Chiropractic Spinal Manipulative Therapy

EXPERIMENTAL

Other: Chiropractic Spinal Manipulative Therapy

Usual Care

OTHER

Other: Usual Care

Interventions

Chiropractic Spinal Manipulative Therapy OTHER

Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.

Chiropractic Spinal Manipulative Therapy

Usual Care OTHER

Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.

Usual Care

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vancouver General Hospital: lead

Study Sites (1)

Integrated Spine Clinic, Blusson Spinal Cord Centre, Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy; Sciatica; Hernia

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 13, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

CA (1)