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

Overview

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.

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. Statistical Analysis Plan The target sample of 34 participants was determined based on the recruitment capacity of the site over the inclusion period. Given the exploratory nature of the study, this sample size was estimated to detect a mean EIFEL score difference of approximately 1.75 points between groups, with 99% statistical power. Analyses will be conducted both in Intention to Treat (ITT) (all included, randomized, and measured participants at S5/S6) and Per Protocol (PP) (excluding participants with major protocol deviations). Statistical methods: Quantitative variables: described by mean, standard deviation, median, quartiles, and extremes. Normality assessed by Shapiro-Wilk test. Group comparisons by Student t-test or Mann-Whitney test according to distribution. Qualitative variables: described by frequencies and percentages. Compared by Pearson Chi² with continuity correction (or Monte-Carlo simulation with 20,000 runs if any cell is below 5), and by Fisher's test for primary and secondary objectives. EIFEL and TAMPA total scores and PILE TEST results: compared between groups at each visit using the appropriate test (t-test or Mann-Whitney). Paired tests will assess intra-group evolution between visits. Longitudinal mixed linear regressions will model the time effect, with baseline score as covariate. Professional situation: analyzed as a categorical variable with Fisher's test. Missing data at M3 and M6: imputed using the Last Observation Carried Forward (LOCF) method. Sensitivity analyses adjusted for potential confounders will be performed. Adverse events: counted per individual and compared by type between study arms. All tests are bilateral with a global alpha risk of 5%. A p-value below 0.05 will be considered statistically significant. All confidence intervals are presented at the 95% level. Statistical analyses will be performed using R software (v4.3.2 or later) by the LNA Santé Research Support Unit. Benefit-Risk Assessment Expected benefits for participants: Significant improvement in functional capacity in activities of daily living Reduction in kinesiophobia Increased functional endurance Identified risks (minimal and infrequent): Transient anxiety increase (paradoxical reaction) Emotional reactivation triggered by music associated with past uncomfortable or distressing experiences In either case, the MUSIC CARE© session is immediately interrupted, the participant is reassured by the investigator, and medical advice is sought if needed. Depending on severity, the intervention may be permanently discontinued for that participant, without affecting standard rehabilitation care or care quality. Regulatory and Ethical Framework This study is classified as RIPH category 2 (minimal risks and constraints) under Art. L1121-1 of the French Public Health Code (Code de la santé publique). It does not require ANSM authorization. Authorization from a Comité de Protection des Personnes (CPP) is required and has been requested. Data management complies with MR-001 reference methodology under the French Data Protection Act and GDPR. Data are pseudonymized and archived for 15 years following study closure. The study is funded exclusively by LNA Santé. The investigative team and sponsor declare no conflicts of interest with the manufacturer of MUSIC CARE©.