Disc Prosthesis Versus Multidisciplinary Rehabilitation
Condition: Chronic Low Back Pain; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional

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.
    

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, 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.

      Sub-studies:

      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.
    

Intervention name(s): Total Disc Prosthesis; Multidisciplinary rehabilitation program
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain; total disc replacement; multidisciplinary rehabilitation; clinical effects; cost effectiveness; randomized controlled trial; multicenter study