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

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: functionnal reeducation

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Pays de Loire
    • Angers, Pays de Loire, France, 49933
      • University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PLURIHOC; -Functionnal reeducation : in hospital, intensive, multidisciplinary.	Other: functionnal reeducation; Specific functionnal reeducation for chronic low back pain
Active Comparator: KIPLURI; -Functionnal reeducation : ambulatory, no intensive multidisciplinary.	Other: functionnal reeducation; Specific functionnal reeducation for chronic low back pain
Active Comparator: KIMONO; -Functionnal reeducation : ambulatory, low-intensity	Other: functionnal reeducation; Specific functionnal reeducation for chronic low back pain

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Isabelle Richard-Crémieux, Md-PhD, UH Angers

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 49RC08_0014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No