Disc Prosthesis Versus Multidisciplinary Rehabilitation
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.
Chronic Low Back Pain
Degenerative Disc Disease
Device: Total Disc Prosthesis
Behavioral: Multidisciplinary rehabilitation program
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Oswestry Disability Index
- Cost-effectiveness (full economic analysis)
- Side effects
- Time out of work
- Fear - avoidance beliefs
- Self - efficacy for pain
- Hopkins symptoms check list
- Drug consumption
- Life satisfaction (EQ 5D and SF - 36)
- Pain (low back pain and leg pain) on VAS
|Study Start Date:||April 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
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, Spine Solutions Inc. , New York, NY). The ProDisc consists of three pieces, two metal endplates and a polyethylene core that is fixed to the inferior endplate when the device is implanted, and is implanted through a retroperitoneal (or transperitoneal) access. Depending on the surgeon, a Pfannenstiel incision or a para median incision is used. A fluoroscope is used to ensure that the prosthesis is placed in the midline and sufficiently towards the posterior edge of the corpus vertebrae. All hospitals participating in the study will use the same artificial lumbar disc device, and standard instruments from the manufacturer are used for inserting the disc. Postoperatively, orthoses will not be used, but patients are given restrictions on heavy lifting and excessive movements the first 6 weeks after surgery. Otherwise, no instructions will be given. Six weeks after surgery, patients will be referred to physiotherapy.
Non-surgical intervention: The intervention is based on a treatment model described by Brox et al (Spine 2003;28:1913-1921) and consists of a cognitive approach and supervised physical exercise. The treatment is interdisciplinary and is directed by a team of physiotherapists and specialists in physical medicine and rehabilitation. The intervention is organized as an outpatient treatment in groups of 6 - 8 patients during a period of 12 - 15 treatment days. In agreement with the patient, individual goals for the rehabilitation process are established.
Several sub - projects will be conducted at the different hospitals in the study, in example validation of discography, RSA to validate the migration and motion of the prosthesis, a biomechanical study using DCRA technique, validation of a classification system for physiotherapy and a responsiveness of questionnaires included in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394732
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Ullevål University Hospital, Orthopedic Centre|
|Oslo, Norway, 0407|
|Stavanger University Hospital|
|Stavanger, Norway, 4068|
|University Hospital of Nothern-Norway|
|Tromsø, Norway, 9038|
|St.Olavs Hospital, NSSL|
|Trondheim, Norway, 7005|
|Study Director:||Kjersti Storheim, PT, PhD||Orthopedic Centre, Ullevål University Hospital / NAR|