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

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ClinicalTrials.gov Identifier: NCT02030171
Recruitment Status : Unknown
Verified January 2014 by University Hospital, Angers.
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE January 8, 2014
Last Update Posted Date January 8, 2014
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
Efficiency of the 3 programs [ Time Frame: One year ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2014)
  • Evolution of quality of life scales [ Time Frame: One year ]
    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. [ Time Frame: One year ]
    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. [ Time Frame: One year ]
    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. [ Time Frame: One year ]
    The secondary endpoints to assess the cost of 1 year from the point of view of health insurance, are the direct and indirect costs.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).
Official Title  ICMJE Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE Other: functionnal reeducation
Specific functionnal reeducation for chronic low back pain
Study Arms  ICMJE
  • Active Comparator: PLURIHOC
    -Functionnal reeducation : in hospital, intensive, multidisciplinary.
    Intervention: Other: functionnal reeducation
  • Active Comparator: KIPLURI
    -Functionnal reeducation : ambulatory, no intensive multidisciplinary.
    Intervention: Other: functionnal reeducation
  • Active Comparator: KIMONO
    -Functionnal reeducation : ambulatory, low-intensity
    Intervention: Other: functionnal reeducation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 6, 2014)
158
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02030171
Other Study ID Numbers  ICMJE 49RC08_0014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle Richard-Crémieux, Md-PhD UH Angers
PRS Account University Hospital, Angers
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP