Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.

This study has been completed.
Sponsor:
Collaborator:
Foundation for Chiropractic Education and Research (FCER)
Information provided by:
McMorland, Gordon, D.C.
ClinicalTrials.gov Identifier:
NCT00415220
First received: December 21, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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
Sciatica
Intervertebral Disk Displacement
Procedure: Spinal Manipulation, Microdiscectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by McMorland, Gordon, D.C.:

Primary Outcome Measures:
  • McGill Pain Score
  • Roland Morris Disability Index
  • Aberdeen Pain Scale
  • SF-36 General Health Survey

Estimated Enrollment: 40
Study Start Date: January 2000
Estimated Study Completion Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415220

Locations
Canada, Alberta
National Spine Care
Calgary, Alberta, Canada, T2N 2A1
University of Calgary, Faculty of Medicine, Division of Neurosurgery
Calgary, Alberta, Canada, T2N 4N1
Sponsors and Collaborators
McMorland, Gordon, D.C.
Foundation for Chiropractic Education and Research (FCER)
Investigators
Principal Investigator: Gordon McMorland
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00415220     History of Changes
Other Study ID Numbers: FCER-99-10-04[99-03-03r]
Study First Received: December 21, 2006
Last Updated: December 21, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMorland, Gordon, D.C.:
Chiropractic
Manipulation
Back surgery
Herniated lumbar disc
Sciatica
Lumbar microdiscectomy
Cost-effectiveness

Additional relevant MeSH terms:
Sciatica
Intervertebral Disc Displacement
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 19, 2014