Overview

This trial is active, not recruiting.

Condition chronic low back pain
Treatment functionnal reeducation
Phase phase 4
Sponsor University Hospital, Angers
Start date April 2009
End date April 2014
Trial size 158 participants
Trial identifier NCT02030171, 49RC08_0014

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 ?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
-Functionnal reeducation : in hospital, intensive, multidisciplinary.
functionnal reeducation
Specific functionnal reeducation for chronic low back pain
(Active Comparator)
-Functionnal reeducation : ambulatory, no intensive multidisciplinary.
functionnal reeducation
Specific functionnal reeducation for chronic low back pain
(Active Comparator)
-Functionnal reeducation : ambulatory, low-intensity
functionnal reeducation
Specific functionnal reeducation for chronic low back pain

Primary Outcomes

Measure
Efficiency of the 3 programs
time frame: One year

Secondary Outcomes

Measure
Evolution of quality of life scales
time frame: One year
Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients.
time frame: One year
Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients.
time frame: One year
Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies.
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?
Principal investigator Isabelle Richard-Crémieux, Md-PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University Hospital, Angers.