Disc Prosthesis Versus Multidisciplinary Rehabilitation

Summary

Surgical methods offered to patients with chronic low back pain are controversial. In addition, new and expensive treatment methods like total disc replacemet (TDR) are a challenge for the health care services. At present, ongoing randomized studies in both Europe and USA are comparing TDR to fusion. However, to our knowledge, no randomized trials have compared TDR to non-surgical treatment. The aim of the present study is to evaluate the effect of a comprehensive and structured non-surgical treatment with TDR surgery in patients with chronic low back pain and localized degenerative disc changes.

Main hypothesis: There is no difference in treatment effect between surgery with lumbar total disc prosthesis and a multidisciplinary rehabilitation program measured by Oswestry Disability Index after 1 and 2 years.

Secondary hypothesis: There is no difference in cost - effectiveness between surgery with lumbar disc prosthesis and a multidisciplinary rehabilitation program after 1 and 2 years.

Conditions

• Chronic Low Back Pain
• Degenerative Disc Disease

Interventions

DEVICE

Total Disc Prosthesis

BEHAVIORAL

Multidisciplinary rehabilitation program

Sponsors & Collaborators

• The Royal Norwegian Ministry of Health

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• University of Tromso

  collaborator OTHER

• Haukeland University Hospital, Dept of neck and back diseases

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Falu Lasarett Röntgen

  collaborator OTHER

• Ullevaal University Hospital

  lead OTHER

Principal Investigators

• Kjersti Storheim, PT, PhD · Orthopedic Centre, Ullevål University Hospital / NAR

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-04-30

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• Norway

Study Locations