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

Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02030171
Acronym
PLURICLEF
Enrollment
158
Registered
2014-01-08
Start date
2009-04-30
Completion date
2014-04-30
Last updated
2014-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain

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.

Interventions

OTHERfunctionnal reeducation

Specific functionnal reeducation for chronic low back pain

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficiency of the 3 programsOne yearCompare 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

MeasureTime frameDescription
Evolution of quality of life scalesOne yearThe 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.One yearThe 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.One yearThe 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.One yearThe secondary endpoints to assess the cost of 1 year from the point of view of health insurance, are the direct and indirect costs.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026