Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).

Study Overview
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Brief Summary
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Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?

Detailed Description
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Compare the efficacy of 1 year of participation, of three programs of care for patients with chronic law back, referred to specialists rehabilitation centers or directly to the multidisciplinary consultation of university hospital of Angers. The primary objectif is to assess the efficacy of 1 year of the three therapeutics strategies with the number of days off work in the year following treatment.

Official Title
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Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: functionnal reeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtaining the signature of consent to participate in the study. Male or female, aged 18-55 years. Diagnosis of common chronic low back pain. Chronic low back pain that led to at least a month off work in the previous year or at least 3 months of stops in the previous 2 years. Employee and holds a permanent contract or a fixed-term contract in the public or private sector. Exclusion Criteria: Lack of consent to participate in the study. No possibily to follow one of three programs of study Pregnant women, new mothers or mothers who are breastfeeding. No affiliation to the french social system.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Active Comparator: PLURIHOC<br>-Functionnal reeducation : in hospital, intensive, multidisciplinary. | Other: functionnal reeducation<br>* Specific functionnal reeducation for chronic low back pain<br>|
| Active Comparator: KIPLURI<br>-Functionnal reeducation : ambulatory, no intensive multidisciplinary. | Other: functionnal reeducation<br>* Specific functionnal reeducation for chronic low back pain<br>|
| Active Comparator: KIMONO<br>-Functionnal reeducation : ambulatory, low-intensity | Other: functionnal reeducation<br>* Specific functionnal reeducation for chronic low back pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of the 3 programs | Compare the efficacy of 1 year of participation of the three programs of care for chronic low back pain patients referred to specialists rehabilitation centers or directly to the multidisciplinary consultation UH Angers. The primary endpoint to assess the efficacy of 1 year of support on the participation of the patient is the number of days off work in the year following treatment. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of quality of life scales | The secondary endpoints to assess the efficacy of 1-year quality of life of the patient is the SF-36 score. The quality of life questionnaire is collected early in the program at the end (after the 5-week program ended) at 6 months and one year. | One year | 
| Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients. | The secondary endpoint to assess the efficacy of 1 year of support on improving social inclusion is the score of Dallas. The Dallas questionnaire is collected early in the program at the end (after the 5-week program ended) at 6 months and one year. | One year | 
| Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients. | The secondary endpoints to assess efficacy at 1 year of support on the physical deconditioning of the patient are the finger-floor distance, Ito test, and the test port heavy load. These tests are performed early in the program at the end (after the program ended five weeks) at 6 months and one year. | One year | 
| Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies. | The secondary endpoints to assess the cost of 1 year from the point of view of health insurance, are the direct and indirect costs. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain