Disc Prosthesis Versus Multidisciplinary Rehabilitation

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00394732
First received: October 31, 2006
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention
Chronic Low Back Pain
Degenerative Disc Disease
Device: Total Disc Prosthesis
Behavioral: Multidisciplinary rehabilitation program

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Oswestry Disability Index
  • Cost-effectiveness (full economic analysis)

Secondary Outcome Measures:
  • 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

Enrollment: 179
Study Start Date: April 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394732

Locations
Norway
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
Investigators
Study Director: Kjersti Storheim, PT, PhD Orthopedic Centre, Ullevål University Hospital / NAR
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kjersti Storheim, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00394732     History of Changes
Other Study ID Numbers: 201006
Study First Received: October 31, 2006
Last Updated: October 11, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by 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:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014