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

Chronic Low Back Pain Clinical Trial

— 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 ?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02030171
• Other study ID #: 49RC08_0014
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 19, 2013
• Last updated: January 6, 2014
• Start date: April 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• functionnal reeducation
Specific functionnal reeducation for chronic low back pain

Locations

Country	Name	City	State
France	University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health	Angers	Pays de Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (5)

Biering-Sørensen 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. — View 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. French. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No