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

NCT07731204 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Receptive Music Therapy

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.

Sponsors & Collaborators

  • LNA SANTE

    lead OTHER

Principal Investigators

  • Mathieu Mr LEDUCQ · LNA SANTE

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731204 on ClinicalTrials.gov