Disc Prosthesis Versus Multidisciplinary Rehabilitation - Full Text View

Sponsor:	Ullevaal University Hospital
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 Stavanger University Hospital Falun Hospital, Peter Fritzell, Sweden
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00394732

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:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Back Pain Rehabilitation Surgery

U.S. FDA Resources

Further study details as provided by Ullevaal 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)

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

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

Stavanger University Hospital

Falun Hospital, Peter Fritzell, Sweden

Investigators

Study Director:

Kjersti Storheim, PT, PhD

Orthopedic Centre, Ullevål University Hospital / NAR

More Information

No publications provided

Study ID Numbers:	201006
Study First Received:	October 31, 2006
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00394732 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

chronic low back pain
total disc replacement
multidisciplinary rehabilitation
clinical effects

cost effectiveness
randomized controlled trial
multicenter study

Additional relevant MeSH terms:

Spinal Diseases
Signs and Symptoms
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Bone Diseases
Back Pain

ClinicalTrials.gov processed this record on November 27, 2009