Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain

NCT ID: NCT00960583

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise program

Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises.

Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

24 group exercise sessions during 12 weeks

Routine follow-up

Routine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active)

Group Type ACTIVE_COMPARATOR

Routine follow-up

Intervention Type OTHER

Advice to stay active

Interventions

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Exercise program

24 group exercise sessions during 12 weeks

Intervention Type OTHER

Routine follow-up

Advice to stay active

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Yves Henchoz

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander KL So, PhD, FRCP

Role: STUDY_DIRECTOR

Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

Pierre de Goumoëns, MD

Role: STUDY_CHAIR

Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

Michael Norberg, MD

Role: STUDY_CHAIR

Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur, Lausanne, Suisse

Roland Paillex, PT, MS

Role: STUDY_CHAIR

Centre Hospitalier Universitaire Vaudois (CHUV), Direction des soins, Lausanne, Suisse

Christophe Pinget, PhD

Role: STUDY_CHAIR

Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)

Jean-Blaise Wasserfallen, MD, MPP

Role: STUDY_CHAIR

Institute of Health Economics and Management, University of Lausanne and Health Technology Assessment Unit, Medical Direction, University Hospital of Lausanne (CHUV)

Yves Henchoz, MS

Role: PRINCIPAL_INVESTIGATOR

Université de Lausanne, Institut des sciences du sport et de l'éducation physique, Lausanne, Suisse

Locations

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Université de Lausanne, Service de Rhumatologie, Département de l'Appareil Locomoteur

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 20098350 (View on PubMed)

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.

Reference Type RESULT
PMID: 20878045 (View on PubMed)

Other Identifiers

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UNIL_PAPA

Identifier Type: -

Identifier Source: org_study_id

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