Impact of the Receptive Music Intervention Tool (MUSIC CARE©) on Changes in the Functional Abilities of Patients With Chronic Low Back Pain

Sponsor
LNA SANTE
Study ID
NCT07731204
Status
Not Yet Recruiting

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Conditions

  • Chronic Low-back Pain (cLBP)
  • Kinesiophobia (Fear of Movement)
  • Low Back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Receptive Music Therapy — DEVICE
    MUSIC 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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Interventional Group : MUSIC CARE© Combined with Standard Rehabilitation
    Participants receive a daily 20-minute receptive music session using the MUSIC CARE© device before each rehabilitation session throughout the 5-to-6-week day hospital stay. Seated comfortably in a dedicated room with headphones, participants listen to a personalized "U-sequence" (induction, deep relaxation, awakening phases). They then proceed to the standard multidisciplinary rehabilitation program, including physiotherapy, occupational therapy, adapted physical activity, and psychomotricity.
  • No Intervention: Control Group : Standard Rehabilitation Alone
    Participants receive the standard multidisciplinary rehabilitation program for chronic low back pain over 5 to 6 weeks, including physiotherapy, occupational therapy, adapted physical activity, and psychomotricity. The program progresses from assessment and motor control work to trunk strengthening and preparation for professional reintegration. No music-based intervention is added.

Primary Outcome Measure

Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at End of Stay [ Time Frame: Baseline (Day 1) and end of stay (Weeks 5 to 6) ]

Central Contacts

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