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

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
functionnal reeducation
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PLURIHOC

KIPLURI

KIMONO

Arm Description

-Functionnal reeducation : in hospital, intensive, multidisciplinary.

-Functionnal reeducation : ambulatory, no intensive multidisciplinary.

-Functionnal reeducation : ambulatory, low-intensity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 19, 2013
Last Updated
January 6, 2014
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02030171
Brief Title
Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).
Acronym
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PLURIHOC
Arm Type
Active Comparator
Arm Description
-Functionnal reeducation : in hospital, intensive, multidisciplinary.
Arm Title
KIPLURI
Arm Type
Active Comparator
Arm Description
-Functionnal reeducation : ambulatory, no intensive multidisciplinary.
Arm Title
KIMONO
Arm Type
Active Comparator
Arm Description
-Functionnal reeducation : ambulatory, low-intensity
Intervention Type
Other
Intervention Name(s)
functionnal reeducation
Intervention Description
Specific functionnal reeducation for chronic low back pain
Primary Outcome Measure Information:
Title
Efficiency of the 3 programs
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Evolution of quality of life scales
Description
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.
Time Frame
One year
Title
Compare the effectiveness of 1 year on improving the social integration of three programs supported in the same patients.
Description
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.
Time Frame
One year
Title
Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients.
Description
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.
Time Frame
One year
Title
Compare the cost of 1 year from the point of view of health insurance, of the three therapeutic strategies.
Description
The secondary endpoints to assess the cost of 1 year from the point of view of health insurance, are the direct and indirect costs.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Richard-Crémieux, Md-PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health
City
Angers
State/Province
Pays de Loire
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15465161
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.
Results Reference
background
PubMed Identifier
16481962
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.
Results Reference
background
PubMed Identifier
10327511
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.
Results Reference
background
PubMed Identifier
15129059
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.
Results Reference
background
PubMed Identifier
6233709
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.
Results Reference
background
PubMed Identifier
28592147
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.
Results Reference
derived
PubMed Identifier
24739659
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.
Results Reference
derived

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

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