- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04133818
Feasibility of a One-day-and-a-half for Patients With Low Back Pain (LC-ONE)
Feasibility of a One-day-and-a-half Multidisciplinary Education and Exercise Therapy Program for Patients With Low Back Pain: a 3-month Retrospective Open Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Retrospectively, data of patients between 18 and 60 years who had benefited in the PMR unit of Cochin' hospital of a one-day-and-a-half no intensive multidisciplinary education and exercise therapy program are collected.
This no intensive multidisciplinary education and exercise therapy program is proposed by the PMR unit of Cochin' hospital to all patients with a subacute or chronic low back pain for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program is not indicated.
It is done in group of 4 to 6 people, performed by medical doctors with experience in the management of patients with low back pain, physiotherapists, occupational therapists, and psychologist.
Data regarding feasibility of this program were recorded with autoquestionnaires that patients had to fill in during the program and 3 months after.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75014
- Hôpital Cochin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age ≥ 18 years
- subacute or chronic non-specific LBP ≥ 6 weeks
- no indication for an intensive multidisciplinary rehabilitation program according to the senior physician, a specialist in physical medicine and rehabilitation and/or rheumatology with a strong experience in the care of patients with non-specific LBP
- currently working
- written consent
Exclusion Criteria:
- inability to speak or read French
- cognitive impairment
- current sick leave
- history of intensive multidisciplinary rehabilitation program for LBP
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multidisciplinary program.
Patients with subacute or chronic LBP for whom first-line treatments had failed but for whom an intensive multidisciplinary rehabilitation program was not indicated.
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Multidisciplinary program: one and a half day of education and exercise therapy about low back pain :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: 3 months
|
Acceptability of the program by the patients (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the best acceptability and 0 the lowest acceptability)
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficiency
Time Frame: 3 months
|
Efficiency of the program to diminish pain (evaluated by a visual analog scale (VAS) between 0 and 100 with 100 representing the most important pain and 0 no pain at all)
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3 months
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Efficiency
Time Frame: 3 months
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Efficiency of the program to diminish fear and beliefs (FABQ, between 0 and 66 with 66 representing the highest level of fear and beliefs about low back pain and 0 representing no fear and beliefs about low back pain)
|
3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Christelle NGUYEN, MD, PhD, APHP (Assistance Publique-Hôpitaux de Paris)
Publications and helpful links
General Publications
- Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
- Adnan R, Van Oosterwijck J, Cagnie B, Dhondt E, Schouppe S, Van Akeleyen J, Logghe T, Danneels L. Determining Predictive Outcome Factors for a Multimodal Treatment Program in Low Back Pain Patients: A Retrospective Cohort Study. J Manipulative Physiol Ther. 2017 Nov-Dec;40(9):659-667. doi: 10.1016/j.jmpt.2017.09.001.
- Brox JI, Storheim K, Grotle M, Tveito TH, Indahl A, Eriksen HR. Systematic review of back schools, brief education, and fear-avoidance training for chronic low back pain. Spine J. 2008 Nov-Dec;8(6):948-58. doi: 10.1016/j.spinee.2007.07.389. Epub 2007 Nov 19.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC-ONE
- APHP190887 (OTHER: APHP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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