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

McMorland, Gordon, D.C.

Status and phase

Completed

Phase 2

Conditions

Intervertebral Disk Displacement

Sciatica

Treatments

Procedure: Spinal Manipulation, Microdiscectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00415220

FCER-99-10-04[99-03-03r]

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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)