Status:
COMPLETED
Disc Prosthesis Versus Multidisciplinary Rehabilitation
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
The Royal Norwegian Ministry of Health
St. Olavs Hospital
Conditions:
Chronic Low Back Pain
Degenerative Disc Disease
Eligibility:
All Genders
25-55 years
Phase:
NA
Brief 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...
Detailed Description
Description of interventions. Surgical intervention: The surgical intervention consists of replacement of the degenerative intervertebral lumbar disc with a artificial lumbar disc device (ProDisc II,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00394732
Start Date
April 1 2004
End Date
September 1 2007
Last Update
October 12 2012
Active Locations (5)
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1
Haukeland University Hospital
Bergen, Bergen, Norway, 5021
2
Ullevål University Hospital, Orthopedic Centre
Oslo, Oslo County, Norway, 0407
3
Stavanger University Hospital
Stavanger, Stavanger, Norway, 4068
4
University Hospital of Nothern-Norway
Tromsø, Tromsø, Norway, 9038