- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00415220
Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.
Comparison of Treatment Outcomes Between Chiropractic and Back Surgery for the Treatment of Sciatica Secondary to Lumbar Herniated Disc: A Prospective Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Context: Operative management of lumbar radiculopathy caused by lumbar disc herniation (LDH) in patients refractory to medical management provides rapid and effective symptom relief. However, both short and long term benefits of surgery continue to be scrutinized.
Objective: To compare clinical efficacy of Chiropractic Treatment against Microdiscectomy in patients suffering from sciatica secondary to LDH.
Study Design: Prospective Randomized Controlled Clinical Trial allowing crossover, recruitment 2000-2004, 1 year follow-up.
Setting: Elective primary care physician referrals made directly to neurosurgical spine surgeons at the Foothills Hospital and Medical Centre, University of Calgary.
Patients: Forty consecutive consenting patients with sciatica from LDH refractory to at least three months of non-operative care and found appropriate for surgery.
Interventions: Surgical microdiscectomy or standardized chiropractic treatment. Crossover to the alternate treatment allowed after 3 months.
Main Outcome Measures: McGill Pain Score, Roland Morris Disability Index, Aberdeen Pain Scale, and SF-36 General Health Survey before treatment initiation and after 3, 6, 12, 24 and 52 weeks.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Alberta
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Calgary, Alberta, Canada, T2N 2A1
- National Spine Care
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Calgary, Alberta, Canada, T2N 4N1
- University of Calgary, Faculty of Medicine, Division of Neurosurgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive patients presenting through elective referral by primary care physicians to one of the three participating spinal neurosurgeons (SC, SJD, RJH) between December 2000 and May 2004 were screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3/4, L4/5 or L5/S1. Detailed surgical histories and physical examinations were performed on each referred patient by the consulting neurosurgeon and correlated with evidence of appropriate root compression on MR imaging. Patients who had failed at least 3 months of non-operative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy and / or acupuncture, and who were felt appropriate for microdiscectomy by the neurosurgeon were asked to consider study participation.
Exclusion Criteria:
- Radicular symptoms < 3 months duration
Major neurological deficits such as:
- Cauda equina syndrome
- Rapidly progressing neurological symptoms (e.g. foot drop)
- Substance abuse
- Hospitalization for intravenous or intramuscular narcotics
- Systemic or visceral disease (e.g. auto-immune diseases, major system failure)
- Hemorrhagic disorders, anticoagulation therapy
- Previous surgery at symptomatic level
- Concurrent chiropractic care at time of enrollment
- Prolonged use of systemic corticosteroids
- Osteopenia/Osteoporosis
- Spondylolisthesis grade III or IV
- Unable to read or speak English
- Age < 18
- Pregnancy
- Dementia or other cognitive impairment
- Unavailable for follow-up (geographic barriers)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
McGill Pain Score
|
Roland Morris Disability Index
|
Aberdeen Pain Scale
|
SF-36 General Health Survey
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gordon McMorland
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCER-99-10-04[99-03-03r]
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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