Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain
Cost-utility Analysis of a 3-month Exercise Program vs. Routine Follow-up in Patients Having Completed Multidisciplinary Rehabilitation: a Randomized Controlled Trial
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. The exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedMay 11, 2016
May 1, 2016
3.8 years
August 17, 2009
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life
End of functional multidisciplinary rehabilitation, 1 year follow-up
Direct and indirect costs
Before functional multidisciplinary rehabilitation, 1 year follow-up
Study Arms (2)
Exercise program
EXPERIMENTALExercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30
Routine follow-up
ACTIVE COMPARATORRoutine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active)
Interventions
Eligibility Criteria
You may qualify if:
- subacute or chronic low back pain
- phases 2 to 6 of the Krause classification
- without irritative neurological deficit
- age between 18 and 60
- having completed functional multidisciplinary rehabilitation
You may not qualify if:
- phases 7 and 8 of the Krause classification
- entitled to a total disability pension
- acute neurological deficit in progress
- sciatica
- pregnancy
- acute inflammatory rheumatic disease
- non-osteoarticular thoracic pain
- spinal fracture within the last 3 months
- osteoporosis
- tumor
- severe heart failure or respiratory failure
- active drug addiction
- current involvement in litigation related to low back pain
- active psychiatric pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur
Lausanne, Switzerland
Related Publications (2)
Henchoz Y, de Goumoens P, Norberg M, Paillex R, So AK. Role of physical exercise in low back pain rehabilitation: a randomized controlled trial of a three-month exercise program in patients who have completed multidisciplinary rehabilitation. Spine (Phila Pa 1976). 2010 May 20;35(12):1192-9. doi: 10.1097/BRS.0b013e3181bf1de9.
PMID: 20098350RESULTHenchoz Y, Pinget C, Wasserfallen JB, Paillex R, de Goumoens P, Norberg M, Kai-Lik So A. Cost-utility analysis of a three-month exercise programme vs usual care following multidisciplinary rehabilitation for chronic low back pain. J Rehabil Med. 2010 Oct;42(9):846-52. doi: 10.2340/16501977-0610.
PMID: 20878045RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexander KL So, PhD, FRCP
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
- STUDY CHAIR
Pierre de Goumoëns, MD
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
- STUDY CHAIR
Michael Norberg, MD
Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
- STUDY CHAIR
Roland Paillex, PT, MS
Centre Hospitalier Universitaire Vaudois (CHUV), Direction des soins, Lausanne, Suisse
- STUDY CHAIR
Christophe Pinget, PhD
Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)
- STUDY CHAIR
Jean-Blaise Wasserfallen, MD, MPP
Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)
- PRINCIPAL INVESTIGATOR
Yves Henchoz, MS
Université de Lausanne, Institut des sciences du sport et de l'éducation physique, Lausanne, Suisse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
January 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 11, 2016
Record last verified: 2016-05