NCT00394732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

3.4 years

First QC Date

October 31, 2006

Last Update Submit

October 11, 2012

Conditions

Chronic Low Back PainDegenerative Disc Disease

Keywords

chronic low back paintotal disc replacementmultidisciplinary rehabilitationclinical effectscost effectivenessrandomized controlled trialmulticenter study

Outcome Measures

Primary Outcomes (2)

  • Oswestry Disability Index

  • Cost-effectiveness (full economic analysis)

Secondary Outcomes (8)

  • Side effects

  • Time out of work

  • Fear - avoidance beliefs

  • Self - efficacy for pain

  • Hopkins symptoms check list

  • +3 more secondary outcomes

Interventions

Total Disc ProsthesisDEVICE
Multidisciplinary rehabilitation programBEHAVIORAL

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Haukeland University Hospital

Bergen, Bergen, 5021, Norway

Location

Ullevål University Hospital, Orthopedic Centre

Oslo, Oslo County, 0407, Norway

Location

Stavanger University Hospital

Stavanger, Stavanger, 4068, Norway

Location

University Hospital of Nothern-Norway

Tromsø, Tromsø, 9038, Norway

Location

St.Olavs Hospital, NSSL

Trondheim, Trondheim, 7005, Norway

Location

Related Publications (5)

  • Hellum C, Johnsen LG, Storheim K, Nygaard OP, Brox JI, Rossvoll I, Ro 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 randomised study. BMJ. 2011 May 19;342:d2786. doi: 10.1136/bmj.d2786.

    PMID: 21596740RESULT

  • Hellum C, Berg L, Gjertsen O, 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 low back pain and degenerative disc: second report of a randomized study. Spine (Phila Pa 1976). 2012 Dec 1;37(25):2063-73. doi: 10.1097/BRS.0b013e318263cc46.

    PMID: 22706091RESULT

  • Hellum C, Johnsen LG, Gjertsen O, 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 and degenerative disc: 2-year follow-up. Eur Spine J. 2012 Apr;21(4):681-90. doi: 10.1007/s00586-011-2145-3. Epub 2012 Jan 13.

    PMID: 22246644RESULT

  • Storheim K, Berg L, Hellum C, Gjertsen O, Neckelmann G, Espeland A, Keller A; Norwegian Spine Study Group. Fat in the lumbar multifidus muscles - predictive value and change following disc prosthesis surgery and multidisciplinary rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up of a randomized trial. BMC Musculoskelet Disord. 2017 Apr 4;18(1):145. doi: 10.1186/s12891-017-1505-5.

    PMID: 28376754DERIVED

  • Johnsen LG, Brinckmann P, Hellum C, Rossvoll I, Leivseth G. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation. Bone Joint J. 2013 Jan;95-B(1):81-9. doi: 10.1302/0301-620X.95B1.29829.

    PMID: 23307678DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Kjersti Storheim, PT, PhD

    Orthopedic Centre, Ullevål University Hospital / NAR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

April 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

NO(5)