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

NCT07731204 | Not Yet Recruiting

• 1 other identifier: 2026-A00502-49
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Low Back Pain; Chronic Pain; Music Therapy; Physical Functional Performance; Kinesiophobia; Fear of Movement; Rehabilitation; Exercise Therapy; Return to Work; Non-Pharmacological Intervention; Patient Reported Outcome Measures; Functional Capacity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1) and end of stay (Weeks 5 to 6)

Secondary Outcomes (9)

• Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at 3 Months

  Baseline (Day 1) and 3 months post-discharge (Day 90 ± 7 days)

• Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at 6 Months

  Baseline (Day 1) and 6 months post-discharge (Day 180 ± 7 days)

• Change from Baseline in Physical Capacity and Functional Endurance as Assessed by the PILE Test at End of Stay

  Baseline (Day 1) and end of stay (Weeks 5 to 6)

• Change from Baseline in Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia at End of Stay

  Baseline (Day 1) and end of stay (Weeks 5 to 6)

• Change from Baseline in Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia at 3 Months

  Baseline (Day 1) and 3 months post-discharge (Day 90 ± 7 days)

Study Arms (2)

Interventional Group : MUSIC CARE© Combined with Standard Rehabilitation

EXPERIMENTAL

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.

Device: Receptive Music Therapy

Control Group : Standard Rehabilitation Alone

NO INTERVENTION

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.

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.

Also known as: Receptive Music Intervention; Digital Music Therapy Tool

Interventional Group : MUSIC CARE© Combined with Standard Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Affiliated with a French social security scheme
• Has given written informed consent to participate in the study

You may not qualify if:

• 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
• Unstable spondylolisthesis
• Disc-vertebral infection (spondylodiscitis)
• Inflammatory rheumatic disease such as ankylosing spondylitis (spondyloarthritis) or rheumatoid arthritis
• Constitutional connective tissue disorder such as Ehlers-Danlos syndrome or Marfan syndrome
• Severe, unstabilized, or decompensated psychiatric disorder, including psychotic disorders, acute-phase bipolar disorder, or severe major depressive episode
• Central nervous system neurological disease such as multiple sclerosis, stroke, or Parkinson's disease
• Peripheral neuropathy of the lower limbs
• Unstabilized cardiovascular disease
• Active cancer treatment or cancer diagnosis within the past 2 years
• Surgery for a reason other than low back pain within the past 6 months
• Currently retired (not in active employment)

Sponsors & Collaborators

• LNA SANTE: lead

Study Sites (1)

Clinique Saint-Roch - LNA SANTE

Roncq, 59223, France

Location

MeSH Terms

Conditions

Low Back Pain; Kinesiophobia; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Mathieu Mr LEDUCQ

  LNA SANTE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva MRS BRIAND

CONTACT

(0)240160161 ext +33; eva.briand@lna-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Study - Single-center, prospective, randomized

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

FR (1)