Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational Support Program Emotiv.
- Who it may be relevant to
- Registry conditions: Chronic Low-back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness of a MOTIVational Support Program After Multidisciplinary Functional Rehabilitation in Chronic Low Back Pain
Overview
Chronic low back pain (CLBP) is a major public health problem. Multidisciplinary functional rehabilitation program (FRP), which give patients the skills to better manage pain and return to physical activity, are effective in the short term. In the medium and long term, due to lack of motivation, two thirds of patients stop their physical activity again, causing them to fall back into the vicious circle of pain. Investigators hypothesise that a remote assessment and motivational support program (MSP) based on an application, piloted by a care coordinator, could allow the continued improvement of symptoms and activities observed after the FRP programs, and thus limit the consequences of CLBP for the patient and society. The main objective of this study is to evaluate the effect of the motivational support program EMOTIV, on disability and pain at one year, in chronic low back pain patients who have benefited from a FRP program.
Detailed description
Multidisciplinary functional rehabilitation program (FRP) have shown their efficacy in disabilitie patient suffering from Chronic low back pain (CLBP). Unfortunately, at medium and long term two thirds of patients stop their physical activity due to lack of motivation. These patients then fall back into their painful vicious circle. Investigators hypothesis that motivational support program (MSP) based on an application, piloted by a care coordinator could increase the motivation to continue physical activity and thus limit the consequences of CLBP for the patient and society. The main objective is to evaluate the impact of a MSP (EMOTIV) on pain and functional abilities assessed according to the COMI scale (Core Outcome Measure Index), 12 months after a FRP in patients with LPBC. This program is compared to usual care as currently done. The secondary criteria concern: physical, neuropsychological and medico-economical criteria. This is a multicentre, cluster randomized trial. All adult patient suffering from low back pain, having finished a FRP and possessing a smartphone, will be included. Investigators plan to include 150 patients in 6 centres. The duration of the inclusion period is 12 months; The duration of participation of each subject is 24 months. Inclusion will be on the last day of the FRP program. The Follow-up in consultation is scheduled at 3, 12 and 24 months with evaluation of usual criteria (physical, self-questionnaires, and advice on the practice of physical activities depending on what is achieved). In Pitie salpetriere center only, patients will have in addition: lumbar MRI at 3 and 12 months; central pain awareness assessment. The activity of patients in the MSP group will be recorded continuously par EMOTIV App; pain, mental health and days off every week and self-questionnaires at 1, 2 and 6 months. The primary analysis of all endpoints will be performed in the intent-to-treat population, i.e. all patients randomized to the study. The COMI score will be compared between the 2 randomized groups by a linear mixed model.
Interventions
- Behavioral Motivational Support Program Emotiv
A motivational support program including a motivational and self-assessment remote application in the form of a Smartphone application for chronic low back pain patients after multidisciplinary functional rehabilitation.
Primary outcome measures
- Difference in disability and pain between the experimental (SHP) and control (usual care) groups, measured with the Core Outcome Measure Index (COMI) scale at 12 months. [Time frame: 12 months after completion of the multidisciplinary functional rehabilitation program]
Secondary outcome measures (12)
- Evolution of pain [Time frame: At 3 months, 12 months and 24 months]
- Evolution of flexibility [Time frame: At 3 months, 12 months and 24 months]
- Evolution of muscular endurance [Time frame: At 3 months, 12 months and 24 months]
- Evolution of muscular endurance [Time frame: At 3 months, 12 months and 24 months]
- Evolution of disability and pain [Time frame: At 3 months, 12 months and 24 months]
- Evolution of endurance and sports performance (VO2 max) [Time frame: At 3 months, 12 months and 24 months]
- Evolution of the intensity of physical activity [Time frame: At 3 months, 12 months and 24 months]
- Evolution of muscular trophicity in the 2 groups [Time frame: At 3 months and 12 months]
- Evolution of the level of anxiety and depression [Time frame: At 3 months, 12 months and 24 months]
- Evolution of the level of central pain awareness [Time frame: At inclusion, 3 months, 12 months and 24 months]
- Medico-economic analysis [Time frame: At 3 months, 12 months and 24 months]
- Cost of care (i.e, health resource use and related costs or direct costs) [Time frame: At 3 months, 12 months and 24 months]
Eligibility criteria
Inclusion criteria
- age 18 or over
- Disabling chronic low back pain: chronic painful patient, that is to say suffering from pain for more than 3 months, having interrupted all physical activity because of low back pain and have an indication for a FRP for low back pain.
- Having reached the end of an FRP program
- Possession of a smartphone
- Fluency in French (writing, reading)
- Health insurance coverage (beneficiary or beneficiary) except State Medical Aid.
- Patient Informed Consent Signature
Exclusion criteria
- Pregnant woman
- Patient refusal
- Patient deprived of liberty and patient under legal protection measure (guardianship, guardianship)
- Patient participating to another interventional search
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hôpital Pitié Salpêtrière — Paris
Identifiers
NCT: NCT05780021 · APHP210077 · 2022-A00828-35