Brief Summary The goal of this clinical trial is to learn if MUSIC CARE©, a music-based therapy tool, can improve the physical abilities of people with chronic low back pain (back pain that lasts more than 3 months).
The main questions it aims to answer are:
Does MUSIC CARE© help participants better perform their daily activities? Does MUSIC CARE© lower the fear of movement in participants? Does MUSIC CARE© help participants return to work?
Why this study? Chronic low back pain is a leading cause of disability and absence from work. Physical rehabilitation is the recommended treatment. However, many participants develop a fear of movement. This fear slows down their recovery and limits the benefits of rehabilitation.
MUSIC CARE© is a digital music tool. It uses specially designed music to help participants relax and feel less pain. Researchers believe that using MUSIC CARE© before rehabilitation sessions may help participants move more freely and recover better.
How does the study work?
Researchers will compare two groups of participants:
Group 1: follows a standard rehabilitation program with MUSIC CARE© Group 2: follows a standard rehabilitation program without MUSIC CARE© This comparison will show whether MUSIC CARE© brings added benefits.
Participants will:
Take part in a rehabilitation program for 5 to 6 weeks Use MUSIC CARE© before each therapy session (Group 1 only). Complete questionnaires about their pain, fear of movement, and ability to perform daily activities.
Be followed for 6 months after the program ends, including an assessment of their return to work.
What could this study change? If results are positive, this study could confirm that MUSIC CARE© is a useful non-drug tool to support rehabilitation for people with chronic low back pain. It could help bring this approach into standard care programs, with no additional medication.
Diagnosed with chronic low back pain by a Physical Medicine and Rehabilitation (PMR) physician, defined as lumbar pain and/or pain radiating to the lower limb that affects daily and professional activities and has lasted more than 3 months
If surgery was performed, it must have been done at least 3 months before entering the study
Adult (18 years of age or older) admitted to the day hospital at Clinique Saint-Roch for a chronic low back pain rehabilitation program
Considered able to return to work, as assessed by the PMR physician during the pre-admission consultation, with no medical contraindication to resuming professional activity
Hearing impairment that would prevent the use of the MUSIC CARE© device
Medical contraindication to hydrotherapy (balneotherapy)
Symptomatic disc herniation
Vertebral fracture or history of recent vertebral fracture within the past 2 years
Parallel
Receptive Music Therapy
DeviceMUSIC CARE© is a Class 1 validated medical device delivering personalized receptive music therapy based on hypnoanalgesia principles. Each session follows a standardized "U-sequence" protocol comprising three phases: an induction phase with gradually decreasing tempo and orchestral complexity; a deep relaxation phase with slow tempo and minimal instrumentation; and a progressive awakening phase. Sessions are set at 20 minutes, administered daily before standard rehabilitation sessions throughout the 5-to-6-week day hospital stay. The sequence is pre-personalized by the investigator according to participant musical preferences collected at inclusion. The participant is seated alone in a dedicated room, wearing headphones connected to the MUSIC CARE© tablet.
Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at End of Stay
The EIFEL (Échelle d'Incapacité Fonctionnelle pour l'Évaluation des Lombalgies) is a validated 24-item self-administered questionnaire, adapted from the Roland-Morris Disability Questionnaire. Each item is answered yes (1) or no (0). The total score ranges from 0 to 24, where 0 indicates no functional disability and 24 indicates maximum functional disability. A higher score reflects greater impairment in daily life activities. A decrease in score indicates improvement in functional capacity. The minimal clinically important difference (MCID) is generally considered to be 2 to 3 points.
Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at 3 Months
The EIFEL is a validated 24-item self-administered questionnaire. Total score ranges from 0 (no disability) to 24 (maximum disability). A decrease in score reflects improvement in functional capacity in daily life activities. Questionnaires are returned by pre-stamped mail.
Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at 6 Months
The EIFEL is a validated 24-item self-administered questionnaire. Total score ranges from 0 (no disability) to 24 (maximum disability). A decrease in score reflects improvement in functional capacity in daily life activities. Questionnaires are returned by pre-stamped mail.
Change from Baseline in Physical Capacity and Functional Endurance as Assessed by the PILE Test at End of Stay
The PILE Test (Progressive Isoinertial Lifting Evaluation) is an objective functional capacity test assessing physical endurance through a progressive incremental lifting task performed over 2 to 3 minutes. The participant lifts increasing loads from floor to waist height until a stopping criterion is reached (pain, exhaustion, or predefined safety threshold). Results are expressed in kilograms lifted and/or as a percentage of body weight. A higher score reflects greater physical capacity and functional endurance.
Change from Baseline in Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia at End of Stay
The Tampa Scale of Kinesiophobia (TSK) is a validated 17-item self-administered questionnaire assessing fear of movement and re-injury. Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Total score ranges from 17 to 68, where higher scores indicate greater kinesiophobia. A score of 37 or above is commonly used as a threshold for clinically significant kinesiophobia. A decrease in score indicates reduced fear of movement.
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