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

Study Overview
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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.

Official Title
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Cost-utility Analysis of a 3-month Exercise Program vs. Routine Follow-up in Patients Having Completed Multidisciplinary Rehabilitation: a Randomized Controlled Trial

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: Exercise program
* Other: Routine follow-up


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise program<br>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<br>* 24 group exercise sessions during 12 weeks<br>|
| Active Comparator: Routine follow-up<br>Routine follow-up after functional multidisciplinary rehabilitation by attending physician (Advice to stay active) | Other: Routine follow-up<br>* Advice to stay active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Multidisciplinary rehabilitation, Exercise, Cost-effectiveness