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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: Exercise program; Other: Routine follow-up

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise program; Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30	Other: Exercise program; 24 group exercise sessions during 12 weeks
Active Comparator: Routine follow-up; Routine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active)	Other: Routine follow-up; Advice to stay active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life	End of functional multidisciplinary rehabilitation, 1 year follow-up
Direct and indirect costs	Before functional multidisciplinary rehabilitation, 1 year follow-up

Collaborators and Investigators

• Sponsor: University of Lausanne
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: August 17, 2009
• First Submitted That Met QC Criteria: August 17, 2009
• First Posted (Estimate): August 18, 2009

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Cost-effectiveness; Chronic low back pain; Multidisciplinary rehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UNIL_PAPA