Clinical trial NCT06800144: Effect of Music Therapy on Pain in People With Multiple Sclerosis
Official title: Effect of Telerehabilitation-Based Heart Rate-Synchronized Motor Imagery Music Therapy on Pain, Autonomic Function and Psychosocial Parameters in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, MS
Keywords: Music Therapy in Multiple Sclerosis
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and progressive neurological disease of the central nervous system, often seen between the ages of 20-30. Pain is a very common symptom in people with MS, with a prevalence of 63%. Pain in MS is a symptom that negatively affects individuals' fatigue, anxiety and depression levels, quality of life and sleep quality. In addition, chronic pain affects individuals' autonomic and cognitive functions. Music therapy is defined as the systematic use of music in a therapeutic relationship that aims to improve, maintain and develop emotional, physical and mental health. Music therapy protocols synchronized with heart rate can be effective on chronic pain through the regulation of the autonomic nervous system and activation of the parasympathetic nervous system. Studies indicate that music therapy, regardless of the population applied, is effective in the management of symptoms such as pain, depression and anxiety. Motor imagery training is a method that regulates cerebral cortex activity by exposing the brain to visual information and imagination, reduces abnormal cortical activation, and thus restores the brain's ability to change. Research indicates that the most effective motor imagery training in reducing pain is motor imagery training presented in a protocol graded from simple to complex motor tasks.

The grading principle applied in motor imagery training in the form of imagining movements from simple to complex and music therapy training presented in a rhythm matched with heart rate rhythm are effective approaches on chronic pain. It is thought that the treatment protocol in which these two methods are combined and their therapeutic effects are combined in MS rehabilitation may be more effective on pain and related factors in MS. The aim of the study is to show the effects of telerehabilitation-based heart rate-synchronized music therapy protocols on pain, heart rate, fatigue, anxiety, depression, quality of life, sleep quality, and information processing speed compared to MS individuals who continue their routine treatments.

45 MS people with chronic pain will be included in the planned randomized controlled trial. The included participants will be randomized into 3 groups with 15 participants in each group. The evaluations will be performed three times before treatment, at 8th (post-treatment evaluation) and 12th weeks (follow-up evaluation). The participants' general pain intensity in the last 2 and 7 days, the presence of neuropathic pain, fatigue level, anxiety and depression levels, sleep quality, health-related quality of life and information processing speed will be evaluated. In addition, heart rate variability will be evaluated in order to evaluate the participants' autonomic functions. Telerehabilitation-based music therapy application will be given to the participants 2 days a week for 8 weeks using a videoconferencing platform under the guidance of a physiotherapist. The heart rates of the participants will be monitored throughout the session. The participants included in the first group will visualize the movements presented with the metronome sound in a rhythm matched to their heart rates, while the participants included in the second group will listen to relaxing/relaxing music without lyrics in a rhythm matched to their heart rates. When synchronization is achieved between the music rhythm and the heart rate in both groups, the music rhythm will be reduced. Participants included in the 3rd group will continue their routine treatment and will be evaluated only three times: at the beginning, after the 8th week and after the 12th week. The results obtained from this study will examine the effects of heart rate synchronized music therapy protocols on pain, autonomic function and psychosocial parameters in individuals with chronic pain and MS.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65.
* Having a definite MS diagnosis according to the 2017 McDonald criteria.
* Having a pain level of at least 3 and above on the numerical pain scale for at least 3 months.
* Not having had an attack in the last 3 months.
* Having a tablet or computer with an active internet connection that is suitable for videoconferencing.
* Having a smartphone to which the heart rate monitor can be connected with the Bluetooth feature so that the heart rate synchronized music therapy training can be given.
* Having sufficient smartphone/tablet or computer knowledge to participate in the study or having a relative who can help in this regard.
* No change in the medications used for pain in the last 2 months.
* Not receiving any additional treatment other than routine treatments.
* Being able to read and understand Turkish.

Exclusion Criteria:

* Having a serious musculoskeletal, cardiovascular, pulmonary, metabolic or other disease that would prevent participation in the study.
* Having a condition other than MS that can cause pain, such as cancer, diabetes, significant osteoarthritis or rheumatoid arthritis, based on laboratory or imaging findings
* Having a psychiatric disease (such as active psychotic disorders, severe depression, anxiety disorders) that would prevent participation in the study and having a serious cognitive disorder determined by a physician that would prevent testing
* Having a serious vision or hearing problem.
* Being pregnant.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline, week 8 and week 12
Secondary outcomes:
measure: PainDETECT
timeFrame: Baseline, week 8 and week 12
measure: Nordic Musculoskeletal Questionnaire
timeFrame: Baseline, week 8 and week 12
measure: Central Sensitization Questionnaire- Short Form
timeFrame: Baseline, week 8 and week 12
measure: Modified Fatigue Impact Scale
timeFrame: Baseline, week 8 and week 12
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline, week 8 and week 12
measure: Preference Based MS Index
timeFrame: Baseline, week 8 and week 12
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, week 8 and week 12
measure: Heart Rate Variability
timeFrame: Baseline, week 8 and week 12
measure: Paced Auditory Serial Addition Test
timeFrame: Baseline, week 8 and week 12
Other outcomes:
Locations:
Study officials:
References: