Clinical trial NCT05780021: Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation
Official title: Evaluation of the Effectiveness of a MOTIVational Support Program After Multidisciplinary Functional Rehabilitation in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic Low-back Pain
Multidisciplinary function rehabilitation
Motivational Support Program Emotiv
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: 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.
timeFrame: 12 months after completion of the multidisciplinary functional rehabilitation program
Secondary outcomes:
measure: Evolution of pain
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of flexibility
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of muscular endurance
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of muscular endurance
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of disability and pain
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of endurance and sports performance (VO2 max)
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of the intensity of physical activity
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of muscular trophicity in the 2 groups
timeFrame: At 3 months and 12 months
measure: Evolution of the level of anxiety and depression
timeFrame: At 3 months, 12 months and 24 months
measure: Evolution of the level of central pain awareness
timeFrame: At inclusion, 3 months, 12 months and 24 months
measure: Medico-economic analysis
timeFrame: At 3 months, 12 months and 24 months
measure: Cost of care (i.e, health resource use and related costs or direct costs)
timeFrame: At 3 months, 12 months and 24 months
measure: Cost of care (i.e, health resource use and related costs or direct costs)
timeFrame: At 3 months, 12 months and 24 months
measure: Cost of care (i.e, health resource use and related costs or direct costs)
timeFrame: At 3 months, 12 months and 24 months
measure: Cost of care (i.e, health resource use and related costs or direct costs)
timeFrame: At 3 months, 12 months and 24 months
measure: Sick leave days
timeFrame: At 3 months, 12 months and 24 months
measure: Productivity loss (i.e, sick leave-related costs or indirect costs)
timeFrame: At 3 months, 12 months and 24 months
measure: Satisfaction with the program
timeFrame: At 3 months, 12 months and 24 months
measure: Adherence to the program
timeFrame: At 3 months, 12 months and 24 months
measure: Adherence to the program
timeFrame: At 3 months, 12 months and 24 months
measure: Adherence to the program
timeFrame: At 3 months, 12 months and 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
name: Violaine FOLTZ, Dr
role: PRINCIPAL_INVESTIGATOR
References: