Impact of the Receptive Music Intervention Tool (MUSIC CARE©) on Changes in the Functional Abilities of Patients With Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Functional Disability as Assessed by the EIFEL Questionnaire at End of Stay
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •Currently enrolled in another interventional research study
- •Persons under legal protection as defined by Articles L.1121-5 to L.1121-8 of the French Public Health Code, including:
- •Persons under guardianship, curatorship, or judicial protection
- •Minors (under 18 years of age)
- •Pregnant or breastfeeding women
- •Any person subject to a legal protection measure or unable to freely provide informed consent
Outcomes
Primary Outcomes
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)
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.
Secondary Outcomes
- 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))
- Change from Baseline in Kinesiophobia as Assessed by the Tampa Scale of Kinesiophobia at 6 Months(Baseline (Day 1) and 6 months post-discharge (Day 180 ± 7 days))
- Change from Baseline in Professional Situation at End of Stay(Baseline (Day 1) and end of stay (Weeks 5 to 6))
- Change from Baseline in Professional Situation at 3 Months(Baseline (Day 1) and 3 months post-discharge (Day 90 ± 7 days))
- Change from Baseline in Professional Situation at 6 Months(Baseline (Day 1) and 6 months post-discharge (Day 180 ± 7 days))