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

NCT ID: NCT01552486

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Acute Sciatica Lumbar Disc Herniation

Keywords

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chiropractic manipulation radiculopathy sciatica lumbar disc herniation protrusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Chiropractic Spinal Manipulative Therapy

Group Type EXPERIMENTAL

Chiropractic Spinal Manipulative Therapy

Intervention Type OTHER

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

Usual Care

Group Type OTHER

Usual Care

Intervention Type OTHER

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

Interventions

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Chiropractic Spinal Manipulative Therapy

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul Bishop

Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul B Bishop, DC, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia

Locations

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

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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1R21AT006773-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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