Disc Prosthesis Versus Multidisciplinary Rehabilitation

October 11, 2012 updated by: Kjersti Storheim, Ullevaal University Hospital

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital
      • Oslo, Norway, 0407
        • Ullevål University Hospital, Orthopedic Centre
      • Stavanger, Norway, 4068
        • Stavanger University Hospital
      • Tromsø, Norway, 9038
        • University Hospital of Nothern-Norway
      • Trondheim, Norway, 7005
        • St.Olavs Hospital, NSSL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oswestry Disability Index
Cost-effectiveness (full economic analysis)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

University of Tromso
Helse Stavanger HF
Haukeland University Hospital
St. Olavs Hospital
The Royal Norwegian Ministry of Health
Haukeland University Hospital, Dept of neck and back diseases
Falu Lasarett Röntgen

Investigators

  • Study Director: Kjersti Storheim, PT, PhD, Orthopedic Centre, Ullevål University Hospital / NAR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Degenerative Disc Disease

Clinical Trials on Total Disc Prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe