Status:
COMPLETED
Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.
Lead Sponsor:
McMorland, Gordon, D.C.
Collaborating Sponsors:
Foundation for Chiropractic Education and Research (FCER)
Conditions:
Sciatica
Intervertebral Disk Displacement
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 refra...
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 sho...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00415220
Start Date
January 1 2000
End Date
May 1 2004
Last Update
December 22 2006
Active Locations (2)
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1
National Spine Care
Calgary, Alberta, Canada, T2N 2A1
2
University of Calgary, Faculty of Medicine, Division of Neurosurgery
Calgary, Alberta, Canada, T2N 4N1