Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT00415220|
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : December 22, 2006
|Condition or disease||Intervention/treatment||Phase|
|Sciatica Intervertebral Disk Displacement||Procedure: Spinal Manipulation, Microdiscectomy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Study Start Date :||January 2000|
|Estimated Study Completion Date :||May 2004|
- McGill Pain Score
- Roland Morris Disability Index
- Aberdeen Pain Scale
- SF-36 General Health Survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415220
|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|