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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415220
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : December 22, 2006
Foundation for Chiropractic Education and Research (FCER)
Information provided by:
McMorland, Gordon, D.C.

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.

Condition or disease Intervention/treatment Phase
Sciatica Intervertebral Disk Displacement Procedure: Spinal Manipulation, Microdiscectomy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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.
Study Start Date : January 2000
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. McGill Pain Score
  2. Roland Morris Disability Index
  3. Aberdeen Pain Scale
  4. SF-36 General Health Survey

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00415220

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)
Principal Investigator: Gordon McMorland Identifier: NCT00415220     History of Changes
Other Study ID Numbers: FCER-99-10-04[99-03-03r]
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: December 22, 2006
Last Verified: December 2006

Keywords provided by McMorland, Gordon, D.C.:
Back surgery
Herniated lumbar disc
Lumbar microdiscectomy

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