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Sponsors and Collaborators: |
McMorland, Gordon, D.C. Foundation for Chiropractic Education and Research |
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Information provided by: | McMorland, Gordon, D.C. |
ClinicalTrials.gov Identifier: | NCT00415220 |
The purpose of this study was to compare standardized chiropractic treatment (spinal manipulation) to back surgery (microdiscectomy) for patients with sciatica secondary to lumbar herniated disc refractory to medical management.
Condition | Intervention | Phase |
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Sciatica Intervertebral Disk Displacement |
Procedure: Spinal Manipulation, Microdiscectomy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Comparison of Treatment Outcomes Between Chiropractic and Back Surgery for the Treatment of Sciatica Secondary to Lumbar Herniated Disc: A Prospective Randomized Controlled Trial. |
Estimated Enrollment: | 40 |
Study Start Date: | January 2000 |
Estimated Study Completion Date: | May 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Major neurological deficits such as:
Canada, Alberta | |
National Spine Care | |
Calgary, Alberta, Canada, T2N 2A1 | |
University of Calgary, Faculty of Medicine, Division of Neurosurgery | |
Calgary, Alberta, Canada, T2N 4N1 |
Principal Investigator: | Gordon McMorland | Unaffiliated |
Study ID Numbers: | FCER-99-10-04[99-03-03r] |
Study First Received: | December 21, 2006 |
Last Updated: | December 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00415220 |
Health Authority: | Canada: Ethics Review Committee |
Chiropractic Manipulation Back surgery Herniated lumbar disc |
Sciatica Lumbar microdiscectomy Cost-effectiveness |
Spinal Diseases Neuralgia Pain Bone Diseases Mononeuropathies Sciatica Signs and Symptoms |
Musculoskeletal Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Neoplasm Metastasis Neurologic Manifestations Intervertebral Disk Displacement |
Sciatic Neuropathy Nervous System Diseases |