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

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Exercise program

Routine follow-up

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Multidisciplinary rehabilitation, Exercise, Cost-effectiveness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise program

Routine follow-up

Arm Description

Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30

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

Outcomes

Primary Outcome Measures

Quality of life

Direct and indirect costs

Secondary Outcome Measures

Full Information

NCT ID

NCT00960583

First Posted

August 17, 2009

Last Updated

May 10, 2016

Sponsor

University of Lausanne

1. Study Identification

Unique Protocol Identification Number

NCT00960583

Brief Title

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

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Lausanne

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

Chronic low back pain, Multidisciplinary rehabilitation, Exercise, Cost-effectiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise program

Arm Type

Experimental

Arm Description

Exercise program comprising muscle strengthening, cardiovascular training and stretching exercises. Program duration : 12 weeks Sessions frequency : twice per week Session duration : 1h30

Arm Title

Routine follow-up

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exercise program

Intervention Description

24 group exercise sessions during 12 weeks

Intervention Type

Other

Intervention Name(s)

Routine follow-up

Intervention Description

Advice to stay active

Primary Outcome Measure Information:

Title

Quality of life

Time Frame

End of functional multidisciplinary rehabilitation, 1 year follow-up

Title

Direct and indirect costs

Time Frame

Before functional multidisciplinary rehabilitation, 1 year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials: