Clinical trial NCT00960583: Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain
Official title: Cost-utility Analysis of a 3-month Exercise Program vs. Routine Follow-up in Patients Having Completed Multidisciplinary Rehabilitation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Multidisciplinary rehabilitation
Exercise
Cost-effectiveness
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life
timeFrame: End of functional multidisciplinary rehabilitation, 1 year follow-up
measure: Direct and indirect costs
timeFrame: Before functional multidisciplinary rehabilitation, 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur
Study officials:
affiliation: Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
name: Alexander KL So, PhD, FRCP
role: STUDY_DIRECTOR
affiliation: Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
name: Pierre de Goumoëns, MD
role: STUDY_CHAIR
affiliation: Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse
name: Michael Norberg, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire Vaudois (CHUV), Direction des soins, Lausanne, Suisse
name: Roland Paillex, PT, MS
role: STUDY_CHAIR
affiliation: Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)
name: Christophe Pinget, PhD
role: STUDY_CHAIR
affiliation: Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)
name: Jean-Blaise Wasserfallen, MD, MPP
role: STUDY_CHAIR
affiliation: Université de Lausanne, Institut des sciences du sport et de l'éducation physique, Lausanne, Suisse
name: Yves Henchoz, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Henchoz 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.