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Clinical Trials/NCT00415220
NCT00415220
Completed
Phase 2

Comparison of Treatment Outcomes Between Chiropractic and Back Surgery for the Treatment of Sciatica Secondary to Lumbar Herniated Disc: A Prospective Randomized Controlled Trial.

McMorland, Gordon, D.C.2 sites in 1 country40 target enrollmentJanuary 2000

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Sciatica
Sponsor
McMorland, Gordon, D.C.
Enrollment
40
Locations
2
Primary Endpoint
McGill Pain Score
Status
Completed
Last Updated
19 years ago

Overview

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 refractory to medical management.

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.

Registry
clinicaltrials.gov
Start Date
January 2000
End Date
May 2004
Last Updated
19 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
McMorland, Gordon, D.C.

Eligibility Criteria

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/S
  • 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

Outcomes

Primary Outcomes

McGill Pain Score

Roland Morris Disability Index

Aberdeen Pain Scale

SF-36 General Health Survey

Study Sites (2)

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