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

Detailed Description

Background and Rationale Chronic low back pain (CLBP) is defined as habitual lumbar pain persisting for more than three months, with possible radiation to the buttock, iliac crest, or thigh. The Haute Autorité de Santé (HAS) further distinguishes degenerative, non-degenerative, and anatomically non-related forms of the condition.

Although only approximately 10% of acute low back pain episodes progress to CLBP, this minority accounts for 70 to 90% of all direct and indirect costs associated with low back pain. CLBP is the leading cause of disability before age 45, the primary driver of sick leave, and the most frequent occupational disease in France.

Beyond pain, CLBP is characterized by a physical deconditioning syndrome, arising after weeks of restricted activity. Muscle strength and endurance decline, directly impairing functional capacity. This is often compounded by kinesiophobia (Tampa Scale of Kinesiophobia, TSK), an excessive fear of movement stemming from perceived vulnerability to painful injury, which perpetuates activity avoidance and sustains functional limitations.

Current HAS guidelines position structured active rehabilitation as the primary treatment for CLBP: it reduces pain, functional disability, and work incapacity both in the short and long term. The standard rehabilitation program at the study site is multidisciplinary, involving physiotherapy, occupational therapy (OT), adapted physical activity (APA), and psychomotricity.

Despite the recognized efficacy of these programs, clinicians observe that a subset of patients remains significantly impaired by kinesiophobia and motor inhibitions, limiting engagement in rehabilitation. Complementary approaches such as conscious breathing, guided visualization, and directed movement are routinely integrated to address these barriers.

Music therapy has emerged as a promising adjunctive non-pharmacological intervention in chronic pain management. Its analgesic and anxiolytic effects are supported by a systematic review of 25 randomized controlled trials (RCTs) reporting significant improvements in pain, anxiety, sleep quality, and quality of life in chronic pain populations. Proposed neurophysiological mechanisms include increased vagal tone, endorphin secretion, and activation of cerebral reward and emotional regulation networks, resulting in modulation of sensory, cognitive, affective, and behavioral pain components, including reduction of muscular hypertonia.

In the specific context of CLBP rehabilitation, music therapy combined with conventional rehabilitation has been shown to significantly reduce anxiety and depression, with an immediate dose-response effect on pain observed after each session. Furthermore, music may act as a motor disinhibitor by fostering self-confidence and raising awareness of the patient's own motor capacities.

MUSIC CARE© (Class 1 medical device) is the first French digital music innovation designed since 2005 for clinical pain and anxiety reduction. It uses standardized musical composition algorithms based on hypnoanalgesia principles. Its efficacy has been demonstrated across multiple pain populations, including CLBP, neurological and inflammatory pain, postoperative pain, and oncology-related pain, with significant reductions in pain intensity and analgesic and anxiolytic drug consumption.

Despite this evidence, the impact of music therapy on functional capacity and kinesiophobia in CLBP remains insufficiently studied, particularly over extended follow-up periods. Most existing studies focus on brief interventions (5 to 21 days). This study addresses this gap through an extended rehabilitation period (5 to 6 weeks) and a 6-month follow-up, enabling evaluation of medium- and long-term effects.

Study Design LOMBALZIC' is a pilot, monocentric, prospective, randomized study conducted at the Clinique Saint-Roch (Roncq, France), a day hospital (HDJ) specializing in CLBP rehabilitation. It is classified as a Research Involving the Human Person (RIPH) category 2, with minimal risks and constraints under French law (Art. L1121-1 of the Public Health Code).

Study sponsor: LNA Santé Principal investigator: Mathieu LEDUCQ, Occupational Therapist, Clinique Saint-Roch Co-investigators: Alexandre BLAIRON (Physiotherapist); Dr. Fabien MORETTO (Physical Medicine and Rehabilitation, MPR physician) Total study duration: 15 months (planned start: September 2026; planned end: November 2027) Inclusion period: 9 months Follow-up per participant: 6 months Target sample size: 34 participants (individual-level randomization) Data collection: Electronic Case Report Form (eCRF) Randomization: Centralized, performed by the LNA Santé Research Support Unit using R software, with block randomization to ensure balanced group sizes over time. Randomization arms are coded A and B for blinded statistical analysis.

The MUSIC CARE© Intervention MUSIC CARE© is a Class 1 clinically validated medical device (CE-marked), developed in France for non-pharmacological management of pain and anxiety. The device delivers personalized, standardized receptive music therapy based on hypnoanalgesia principles.

Each musical sequence follows a standardized "U-sequence" protocol comprising three phases:

Induction phase: an initially stimulating rhythm aligned with the participant's emotional state, characterized by a progressive decrease in tempo, orchestral complexity, sound frequency, and volume.

Relaxation phase: a reduced number of instruments and a slow tempo enabling deep relaxation.

Awakening phase: a progressive return toward initial musical parameters, without reaching the same stimulation level as at the outset.

The MUSIC CARE© catalogue includes 58 musical sequences, almost exclusively instrumental and always without lyrics, spanning a wide range of musical styles, harmonies, timbres, and melodies to accommodate individual sensitivities, cultural backgrounds, and listening preferences. All sequences are original compositions by professional musicians, designed to meet the U-sequence specifications and to avoid potential emotional revivals triggered by familiar pieces.

Session durations can range from 15 to 90 minutes. In this study, each session is set at 20 minutes.

In the interventional group, each participant receives a 20-minute MUSIC CARE© session each day of their HDJ stay, prior to their standard rehabilitation sessions. The participant is seated alone and comfortably in a dedicated room, wearing headphones connected to the MUSIC CARE© tablet. The U-sequence is pre-selected and configured by the investigator according to the participant's musical preferences collected at inclusion. Immediately following the session, the participant proceeds to their standard rehabilitation program.

The control group receives the standard multidisciplinary rehabilitation program only, without MUSIC CARE©.

MUSIC CARE© is already in use across LNA Santé medico-social facilities. A training session will be conducted before the study begins to ensure standardized use across all personnel involved.

Standard Rehabilitation Program (Both Groups)

All participants follow a structured multidisciplinary rehabilitation program lasting 5 to 6 weeks, organized in four progressive phases:

Week 1: Assessment and orientation Weeks 2 to 3: Mobility work and motor control Weeks 3 to 4: Trunk strengthening and stabilization Weeks 5 to 6: Preparation for professional reintegration, including vocational situational training and self-maintenance exercise program

Each discipline integrates specific work on pain-related beliefs, fears, and motor inhibitions throughout the program. The detailed intervention schedule by discipline and week is provided in Annex X of the protocol.

Study Procedures and Visit Schedule

Pre-inclusion visit (VS): The MPR physician identifies eligible participants during the pre-admission consultation and provides oral information about the study. A participant information letter and a MUSIC CARE© presentation document are provided.

Inclusion visit (Day 0 / J0): On the first day of HDJ admission, written informed consent is obtained. Musical preferences are collected to personalize the intervention.

Baseline and Randomization visit (Day 1 / J1 ±1 day): Baseline assessments are performed (EIFEL questionnaire, TAMPA questionnaire, PILE TEST). Clinical data are collected from the admission file. Randomization is performed, and participants are allocated to their respective group.

Follow-up during stay (J0 to S5/S6): Adverse events (AEs) potentially related to MUSIC CARE© tolerance are monitored throughout the stay.

End-of-stay visit (Weeks 5 to 6 / S5-S6): EIFEL and TAMPA questionnaires are completed; the PILE TEST is performed; a professional situation questionnaire is administered. Two pre-stamped envelopes containing the 3-month and 6-month questionnaires are provided to the participant.

3-month follow-up (J90 ±7 days): EIFEL, TAMPA, and professional situation questionnaires are returned by post. The investigator contacts participants beforehand as a reminder. In case of non-response within 2 weeks, a phone reminder and a second postal mailing are attempted.

6-month follow-up (J180 ±7 days): Same procedure as the 3-month visit. After this visit, participant involvement in the study is complete.

Study withdrawal criteria: Participants may be withdrawn in the event of full hospitalization (24h or more), clinical deterioration preventing protocol continuation, non-compliance (less than 80% adherence to the rehabilitation program), participant withdrawal, or investigator decision.

Assessment Tools EIFEL (Échelle d'Incapacité Fonctionnelle pour l'Évaluation des Lombalgies): A validated 24-item self-administered questionnaire specifically developed to assess the impact of low back pain on activities of daily living. It is the primary outcome instrument.

TAMPA Scale of Kinesiophobia (TSK): A validated 17-item self-administered questionnaire assessing kinesiophobia, scored on a 4-point Likert scale.

PILE TEST (Progressive Isoinertial Lifting Evaluation): A functional capacity test assessing physical capacity and functional endurance through a progressive lifting task (approximately 2 to 3 minutes).

Professional situation questionnaire: A study-specific questionnaire assessing employment status and return-to-work conditions.

Given the nature of the intervention, blinding of participants and caregivers is not feasible. To limit expectation bias and contextual effects, questionnaires are completed autonomously by participants, and assessments are conducted using identical standardized procedures in both groups.

• Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at 3 Months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (Day 1) and 3 months post-discharge (Day 90 ± 7 days)]
• Change from Baseline in Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia at 6 Months [Срок оценки: Baseline (Day 1) and 6 months post-discharge (Day 180 ± 7 days)]
• Change from Baseline in Professional Situation at End of Stay [Срок оценки: Baseline (Day 1) and end of stay (Weeks 5 to 6)]
• Change from Baseline in Professional Situation at 3 Months [Срок оценки: Baseline (Day 1) and 3 months post-discharge (Day 90 ± 7 days)]
• Change from Baseline in Professional Situation at 6 Months [Срок оценки: Baseline (Day 1) and 6 months post-discharge (Day 180 ± 7 days)]