Chronic Low Back PainPhase 4PLURICLEFNCT02030171
Effect of Three Therapeutics Strategies on Patients With a Chronic Back Pain (PLURICLEF).
A Phase 4 study testing functionnal reeducation in people with Chronic Low Back Pain, run by University Hospital, Angers at 1 site in France.
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 ? Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- functionnal reeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health
Angers, Pays de Loire, 49933
About this study
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 ?
Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- functionnal reeducation
- Keywords
- Chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functionnal reeducationOther
Specific functionnal reeducation for chronic low back pain
| Study group | Role | What they receive |
|---|---|---|
| PLURIHOC | Active comparator | -Functionnal reeducation : in hospital, intensive, multidisciplinary. Receives: Other: functionnal reeducation |
| KIPLURI | Active comparator | -Functionnal reeducation : ambulatory, no intensive multidisciplinary. Receives: Other: functionnal reeducation |
| KIMONO | Active comparator | -Functionnal reeducation : ambulatory, low-intensity Receives: Other: functionnal reeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startApr 2009
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Richard-Crémieux, Md-PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030171
- Sponsor's protocol ID
- 49RC08_0014
- Acronym
- PLURICLEF
- Status last verified
- Jan 2014
- First submitted
- 19 Dec 2013
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15465161Leclerc 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.
PubMed 16481962Leggett 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.
PubMed 10327511Jousset 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.
PubMed 15129059Biering-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.
PubMed 6233709Ronzi 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.
PubMed 28592147Petit 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.
PubMed 24739659
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ?
- ClinicalTrials.gov ID
- NCT02030171
- Acronym / sponsor ID
- PLURICLEF / 49RC08_0014
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 2009
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLURIHOC | Active comparator | Other: functionnal reeducation-Functionnal reeducation : in hospital, intensive, multidisciplinary. |
| KIPLURI | Active comparator | Other: functionnal reeducation-Functionnal reeducation : ambulatory, no intensive multidisciplinary. |
| KIMONO | Active comparator | Other: functionnal reeducation-Functionnal reeducation : ambulatory, low-intensity |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functionnal reeducationSpecific functionnal reeducation for chronic low back pain | Other | KIMONO, KIPLURI, PLURIHOC |
Primary outcome
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.
4 secondary outcomes
Evolution of quality of life scales
Time frame: 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
Compare the effectiveness of 1 year on physical deconditioning, three programs of care in these patients.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
- Background: PubMed 15465161Bontoux 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.
- Background: PubMed 16481962Leclerc 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.
- Background: PubMed 10327511Leggett 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.
- Background: PubMed 15129059Jousset 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.
- Background: PubMed 6233709Biering-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.
- Derived from this study: PubMed 28592147Ronzi 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.
- Derived from this study: PubMed 24739659Petit 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.
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Richard-Crémieux, Md-PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing functionnal reeducation in people with Chronic Low Back Pain, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of the 3 programs (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030171, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2014.