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Disc Prosthesis Versus Multidisciplinary Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394732
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : October 12, 2012
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
Information provided by (Responsible Party):
Kjersti Storheim, Oslo University Hospital

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 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

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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : April 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Oswestry Disability Index
  2. Cost-effectiveness (full economic analysis)

Secondary Outcome Measures :
  1. Side effects
  2. Time out of work
  3. Fear - avoidance beliefs
  4. Self - efficacy for pain
  5. Hopkins symptoms check list
  6. Drug consumption
  7. Life satisfaction (EQ 5D and SF - 36)
  8. Pain (low back pain and leg pain) on VAS

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00394732

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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
Sponsors and Collaborators
Ullevaal University Hospital
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
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Study Director: Kjersti Storheim, PT, PhD Orthopedic Centre, Ullevål University Hospital / NAR

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kjersti Storheim, PhD, Oslo University Hospital Identifier: NCT00394732     History of Changes
Other Study ID Numbers: 201006
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Kjersti Storheim, Oslo University Hospital:
chronic low back pain
total disc replacement
multidisciplinary rehabilitation
clinical effects
cost effectiveness
randomized controlled trial
multicenter study
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases