search
Back to results

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

Primary Purpose

Sciatica, Intervertebral Disk Displacement

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Spinal Manipulation, Microdiscectomy
Sponsored by
McMorland, Gordon, D.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring Chiropractic, Manipulation, Back surgery, Herniated lumbar disc, Sciatica, Lumbar microdiscectomy, Cost-effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • National Spine Care
  • University of Calgary, Faculty of Medicine, Division of Neurosurgery

Outcomes

Primary Outcome Measures

McGill Pain Score
Roland Morris Disability Index
Aberdeen Pain Scale
SF-36 General Health Survey

Secondary Outcome Measures

Full Information

First Posted
December 21, 2006
Last Updated
December 21, 2006
Sponsor
McMorland, Gordon, D.C.
Collaborators
Foundation for Chiropractic Education and Research (FCER)
search

1. Study Identification

Unique Protocol Identification Number
NCT00415220
Brief Title
Manipulation or Microdiscectomy For Sciatica? A Prospective Randomized Controlled Trial.
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 Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
McMorland, Gordon, D.C.
Collaborators
Foundation for Chiropractic Education and Research (FCER)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica, Intervertebral Disk Displacement
Keywords
Chiropractic, Manipulation, Back surgery, Herniated lumbar disc, Sciatica, Lumbar microdiscectomy, Cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Spinal Manipulation, Microdiscectomy
Primary Outcome Measure Information:
Title
McGill Pain Score
Title
Roland Morris Disability Index
Title
Aberdeen Pain Scale
Title
SF-36 General Health Survey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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/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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon McMorland
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Spine Care
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2A1
Country
Canada
Facility Name
University of Calgary, Faculty of Medicine, Division of Neurosurgery
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs