Sciatica Clinical Trial
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.
Verified date | December 2006 |
Source | McMorland, Gordon, D.C. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | National Spine Care | Calgary | Alberta |
Canada | University of Calgary, Faculty of Medicine, Division of Neurosurgery | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
McMorland, Gordon, D.C. | Foundation for Chiropractic Education and Research (FCER) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | McGill Pain Score | |||
Primary | Roland Morris Disability Index | |||
Primary | Aberdeen Pain Scale | |||
Primary | SF-36 General Health Survey |
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