Disc Prosthesis Versus Multidisciplinary Rehabilitation
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|ClinicalTrials.gov Identifier: NCT00394732|
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : October 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain Degenerative Disc Disease||Device: Total Disc Prosthesis Behavioral: Multidisciplinary rehabilitation program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|