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

NCT02030171 | Unknown Phase 4

• 1 other identifier: 49RC08_0014
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evolution of quality of life scales

  One year

• Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients.

  One year

• Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients.

  One year

• Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies.

  One year

Study Arms (3)

PLURIHOC

ACTIVE COMPARATOR

-Functionnal reeducation : in hospital, intensive, multidisciplinary.

Other: functionnal reeducation

KIPLURI

ACTIVE COMPARATOR

-Functionnal reeducation : ambulatory, no intensive multidisciplinary.

Other: functionnal reeducation

KIMONO

ACTIVE COMPARATOR

-Functionnal reeducation : ambulatory, low-intensity

Other: functionnal reeducation

Interventions

functionnal reeducation OTHER

Specific functionnal reeducation for chronic low back pain

KIMONO; KIPLURI; PLURIHOC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

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

Angers, Pays de Loire, 49933, France

Location

Related Publications (7)

• 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.

  PMID: 15465161 BACKGROUND

• 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.

  PMID: 16481962 BACKGROUND

• 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.

  PMID: 10327511 BACKGROUND

• 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.

  PMID: 15129059 BACKGROUND

• 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.

  PMID: 6233709 BACKGROUND

• 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.

  PMID: 28592147 DERIVED

• 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.

  PMID: 24739659 DERIVED

Study Officials

• Isabelle Richard-Crémieux, Md-PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 8, 2014
• Study Start: April 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

FR (1)