Disc Prosthesis Versus Multidisciplinary Rehabilitation

Chronic Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394732
• Other study ID #: 201006
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: October 11, 2012
• Start date: April 2004
• Est. completion date: September 2007

Study information

• Verified date: October 2012
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Device:
• Total Disc Prosthesis

Behavioral:
• Multidisciplinary rehabilitation program

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Ullevål University Hospital, Orthopedic Centre	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	University Hospital of Nothern-Norway	Tromsø
Norway	St.Olavs Hospital, NSSL	Trondheim

Sponsors (8)

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

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Hellum C, Berg L, Gjertsen Ø, Johnsen LG, Neckelmann G, Storheim K, Keller A, Grundnes O, Espeland A; Norwegian Spine Study Group. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or rehabilitation in patients with chronic l — View Citation

Hellum C, Johnsen LG, Gjertsen Ø, Berg L, Neckelmann G, Grundnes O, Rossvoll I, Skouen JS, Brox JI, Storheim K; Norwegian Spine Study Group. Predictors of outcome after surgery with disc prosthesis and rehabilitation in patients with chronic low back pain — View Citation

Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Rø M, Sandvik L, Grundnes O; Norwegian Spine Study Group. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of ran — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index
Primary	Cost-effectiveness (full economic analysis)
Secondary	Side effects
Secondary	Time out of work
Secondary	Fear - avoidance beliefs
Secondary	Self - efficacy for pain
Secondary	Hopkins symptoms check list
Secondary	Drug consumption
Secondary	Life satisfaction (EQ 5D and SF - 36)
Secondary	Pain (low back pain and leg pain) on VAS