Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).
- Conditions
- Chronic Low Back Pain
- Interventions
- Other: functionnal reeducation
- Registration Number
- NCT02030171
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 158
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PLURIHOC functionnal reeducation -Functionnal reeducation : in hospital, intensive, multidisciplinary. KIPLURI functionnal reeducation -Functionnal reeducation : ambulatory, no intensive multidisciplinary. KIMONO functionnal reeducation -Functionnal reeducation : ambulatory, low-intensity
- Primary Outcome Measures
Name Time Method Efficiency of the 3 programs One year 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.
- Secondary Outcome Measures
Name Time Method Evolution of quality of life scales One year 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.Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients. One year 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.Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients. One year 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.Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies. One year The secondary endpoints to assess the cost of 1 year from the point of view of health insurance, are the direct and indirect costs.
Trial Locations
- Locations (1)
University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health
🇫🇷Angers, Pays de Loire, France