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

NCT ID: NCT02030171

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-04-30

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLURIHOC

-Functionnal reeducation : in hospital, intensive, multidisciplinary.

Group Type: ACTIVE_COMPARATOR

functionnal reeducation

Intervention Type: OTHER

Specific functionnal reeducation for chronic low back pain

KIPLURI

-Functionnal reeducation : ambulatory, no intensive multidisciplinary.

Group Type: ACTIVE_COMPARATOR

functionnal reeducation

Intervention Type: OTHER

Specific functionnal reeducation for chronic low back pain

KIMONO

-Functionnal reeducation : ambulatory, low-intensity

Group Type: ACTIVE_COMPARATOR

functionnal reeducation

Intervention Type: OTHER

Specific functionnal reeducation for chronic low back pain

Interventions

functionnal reeducation

Specific functionnal reeducation for chronic low back pain

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Richard-Crémieux, Md-PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health

Angers, Pays de Loire, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 15465161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16481962 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10327511 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15129059 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6233709 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28592147 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24739659 (View on PubMed)

Other Identifiers

49RC08_0014

Identifier Type: -

Identifier Source: org_study_id