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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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 ?

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Other: functionnal reeducation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2009
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02030171


Locations
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France
University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health
Angers, Pays de Loire, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Isabelle Richard-Crémieux, Md-PhD UH Angers

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02030171    
Other Study ID Numbers: 49RC08_0014
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014
Keywords provided by University Hospital, Angers:
Chronic low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms