Disc Prosthesis Versus Multidisciplinary Rehabilitation
CompletedNot applicableNCT00394732
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation Program in Patients With Chronic Low Back Pain and Degenerative Disc. A Prospective Randomized Clinical Multicentre Trial.
- Interventions
- Device: Total Disc Prosthesis
- Behavioral: Multidisciplinary rehabilitation program
- Sponsor
- Ullevaal University Hospital
- Collaborators
- The Royal Norwegian Ministry of Health; St. Olavs Hospital; University of Tromso; Haukeland University Hospital, Dept of neck and back diseases; Haukeland University Hospital; Helse Stavanger HF; Falu Lasarett Röntgen
- Organization
- Oslo University Hospital
- Start date
- 2004-04
- Primary completion
- 2007-09
- Sex
- All
- Age range
- from 25 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 5
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Low back pain as the main symptom for at least one year. * Structured physiotherapy or chiropractic treatment for at least 6 months without (significant) effect. * Oswestry Disability Index score of 30% points or more * Degenerative changes in the intervertebral disc in one or both of the two lowest levels of the lumbar spine (L4/L5 and/or L5/S1). (Degenerative changes are classified based on MR findings according to the following criteria: At least 40% reduction of disc height, Modic changes type I and/or II, "High intensity zone" in the disc, Morphological changes classified as changes in signal intensity in the disc. To classify the disc as degenerative the first criteria alone or at least two of the other criteria must be present. The MR series are evaluated by two independent observers.) Exclusion Criteria: * Generalized chronic pain syndrome (widespread myofascial pain) * Degeneration established in more than two levels. To be classified as a normal disc, the disc height must not be reduced more than 40% and all other criteria of degenerative disc disease aforementioned must be absent. The classification of a normal disc is performed by two independent observers. If disagreement, the pictures will be classified by a third observer and the outcome decided by simple majority. * Symptoms of spinal stenosis * Disc protrusion or recess stenosis with nerve root affection * Spondylolysis * Isthmic spondylolisthesis * Arthritis * Former fracture of L1 - S1 * Ongoing psychiatric or somatic disease that excludes either one or both treatment alternatives * Does not understand Norwegian language, spoken or in writing * Drug abuse * Osteoporosis * Congenital or acquired deformity
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00394732