Clinical trial NCT02030171: Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).
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 ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-01-08
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficiency of the 3 programs
timeFrame: One year
Secondary outcomes:
measure: Evolution of quality of life scales
timeFrame: One year
measure: Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients.
timeFrame: One year
measure: Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients.
timeFrame: One year
measure: Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies.
timeFrame: One year
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health
state: Pays de Loire
Study officials:
affiliation: UH Angers
name: Isabelle Richard-Crémieux, Md-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bontoux L, Roquelaure Y, Billabert C, Dubus V, Sancho PO, Colin D, Brami L, Moisan S, Fanello S, Penneau-Fontbonne D, Richard I. [Prospective study of the outcome at one year of patients with chronic low back pain in a program of intensive functional restoration and ergonomic intervention. Factors predicting their return to work]. Ann Readapt Med Phys. 2004 Oct;47(8):563-72. doi: 10.1016/j.annrmp.2004.03.006. French.
citation: Leclerc A, Chastang JF, Ozguler A, Ravaud JF. Chronic back problems among persons 30 to 64 years old in France. Spine (Phila Pa 1976). 2006 Feb 15;31(4):479-84. doi: 10.1097/01.brs.0000199939.53256.e0.
citation: Leggett S, Mooney V, Matheson LN, Nelson B, Dreisinger T, Van Zytveld J, Vie L. Restorative exercise for clinical low back pain. A prospective two-center study with 1-year follow-up. Spine (Phila Pa 1976). 1999 May 1;24(9):889-98. doi: 10.1097/00007632-199905010-00010.
citation: Jousset N, Fanello S, Bontoux L, Dubus V, Billabert C, Vielle B, Roquelaure Y, Penneau-Fontbonne D, Richard I. Effects of functional restoration versus 3 hours per week physical therapy: a randomized controlled study. Spine (Phila Pa 1976). 2004 Mar 1;29(5):487-93; discussion 494. doi: 10.1097/01.brs.0000102320.35490.43.
citation: Biering-Sorensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine (Phila Pa 1976). 1984 Mar;9(2):106-19. doi: 10.1097/00007632-198403000-00002.
citation: Ronzi Y, Roche-Leboucher G, Begue C, Dubus V, Bontoux L, Roquelaure Y, Richard I, Petit A. Efficiency of three treatment strategies on occupational and quality of life impairments for chronic low back pain patients: is the multidisciplinary approach the key feature to success? Clin Rehabil. 2017 Oct;31(10):1364-1373. doi: 10.1177/0269215517691086. Epub 2017 Feb 13.
citation: Petit A, Roche-Leboucher G, Bontoux L, Dubus V, Ronzi Y, Roquelaure Y, Richard I. Effectiveness of three treatment strategies on occupational limitations and quality of life for patients with non-specific chronic low back pain: Is a multidisciplinary approach the key feature to success: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 16;15:131. doi: 10.1186/1471-2474-15-131.