No registrations found.
ID
Source
Brief title
Health condition
chronic musculoskeletal pain disorders
Sponsors and support
Intervention
Outcome measures
Primary outcome
Numeric pain Ratomg Scale, Quality of Life (EuroQol - 5D 3L)
Secondary outcome
Pain disability index (PDI), Quantitative Sensory Testing (QST), Central sensitization index (CSI), Depression and Anxiety (HADS), Safety (UTAUT) and treatment satisfaction (ARTS)
Background summary
HALF-MIS (High Amplitude Low Frequency Music Impulse Stimulation)’, is an innovative treatment modality aimed at stimulation of the Pacinian bodies with the use of infrasound to stimulate vagal activity. Previously, substantial effects were demonstrated on reduction of depression. It is, however, expected to be effective when used in pain management.
Study objective
1. HALF-MIS is a safe and well tolerated intervention. 2. HALF-MIS decreases pain significantly compared to a placebo treatment in elderly patients suffering from chronic musculoskeletal pain. 3. Central sensitization mediates the effect of HALF-MIS.
Study design
Visit 1. screening
Visit 2. HALFMIS, NRS, EQ 5D-L3, PDI,QST,CSI,HADS,
Visit 3-8. HALFMIS, NRS
Visit 9. HALFMIS, NRS, EQ 5D-L3, PDI,QST,CSI,HADS
Visit 10. 6 weeks after visit 9. NRS, EQ 5D-L3, PDI,QST,CSI,HADS, UTAUT, ARTS
Visit 2-9 in 3 weekly treatments over course of 3 weeks, 8 treatments in total
Intervention
Each patient will have a schedule consisting of 3 weekly treatments over the course of 3 weeks. Each session will last 20 minutes and 27 seconds according to the length of the music. In all of the eight visits, patients in the treatment group will undergo the HALF-MIS treatment. For this treatment the patient have to sit in a chair and get a belt around the waist with a built-in vibro-tactile unit which delivers vibro-stimulation. For the music patients get a headphone. An iOS app is used to administer the stimuli, synchronize the audio and log the patients’ treatments. Patients in the placebo group will follow the same procedure, but without the vibro-stimulation.
Inclusion criteria
1. The symptoms of pain have been present for 3 months or more
2. The symptoms of pain are present every day with a minimum level of NRS=4 (Moderate and severe pain)
3. The symptoms of pain are resulting from a condition diagnosed as a musculoskeletal disease listed in the ICD-10 of the WHO M00-M99.9 (But NOT M50.0, M50.1, M51.0 and M51.1 that are Prolapsus Disci Intervertebralis with myelopathy/radiculopathies – as the pain syndrome in these cases are expected to be predominantly neurogenic)
4. Adequate communication and understanding of the language
5. Age ≥ 65 years
6. Available during the intervention.
Exclusion criteria
1. The medical examination showing signs of significant active, untreated comorbidities. Excluded are patients with Delirium and/or psychotic symptoms or moderate or severe depression. The distinction between light depression and moderate and severe depression is done according to the ICD-10: Light depression is F32.0 – moderate and severe depression are F32.1 and F32.2.
2. Patients with decreased signs of autonomic responses, metal implants such as ICD, organ transplantations and surgery on central nervous system in history.
3. The medical examination showing signs of the pain syndrome being exclusively or predominantly neurogenic with the condition diagnosed as a neurological disease listed in the WHO G00-G99.8.
4. The belt doesn’t fit properly.
5. Pain related to malignancies.
6. Enrolled in any other clinical study within the duration of the current study.
7. Enrolled in other music therapy.
8. Incapable of giving consent.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7606 |
| CCMO | NL69608.042.19 |
| OMON | NL-OMON49209 |