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

NCT00415220 | Completed Phase 2

• 1 other identifier: FCER-99-10-04[99-03-03r]
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Sciatica; Intervertebral Disk Displacement

Keywords

Chiropractic; Manipulation; Back surgery; Herniated lumbar disc; Sciatica; Lumbar microdiscectomy; Cost-effectiveness

Outcome Measures

Primary Outcomes (4)

• McGill Pain Score

• Roland Morris Disability Index

• Aberdeen Pain Scale

• SF-36 General Health Survey

Interventions

Spinal Manipulation, Microdiscectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMorland, Gordon, D.C.: lead
• Foundation for Chiropractic Education and Research (FCER): collaborator

Study Sites (2)

National Spine Care

Calgary, Alberta, T2N 2A1, Canada

Location

University of Calgary, Faculty of Medicine, Division of Neurosurgery

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Sciatica; Intervertebral Disc Displacement

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Gordon McMorland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: January 1, 2000
• Study Completion: May 1, 2004
• Last Updated: December 22, 2006

Record last verified: 2006-12

Locations

CA (2)