1. To investigate the tolerability and safety of HALF-MIS used in elderly patients with chronic musculoskeletal pain.2. To investigate the effect on pain of HALF-MIS used in elderly patients with chronic musculoskeletal pain.3. To investigate the…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
per objective:
1. Safety and tolerability: (S)AE listings, UTAUT and ARTS
2. Self-reported pain: NRS
3. Quantitative Sensory Testing (QST)
Secondary outcome
per objective:
1. Not applicable
2. Pain disability index: PDI; Quality of life: EuroQoL 5D3L
3. Central sensitization index: CSI
Background summary
Chronic musculoskeletal pain is a disabling condition with huge individual and
societal impact in Western society. A considerable amount of patients have
decreased functional and biological capacities and lack resilience to stand
current treatment standards, including surgery, or medication to handle their
pain optimally. Besides, current treatments suffer from side effects. There is
a high demand on the development of non-invasive treatments without side
effects.
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. To investigate the tolerability and safety of HALF-MIS used in elderly
patients with chronic musculoskeletal pain.
2. To investigate the effect on pain of HALF-MIS used in elderly patients with
chronic musculoskeletal pain.
3. To investigate the effect on central sensitization of HALF-MIS used in
elderly patients with chronic musculoskeletal pain.
Study design
Placebo controlled pilot study
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.
Study burden and risks
In total there are 10 visits: 1 screening, 8 treatments and 1 follow-up. During
the screening patients will be asked about their medical history and get a
physical examination. During the first, last en follow-up visits patients have
to fill in questionnaires. The first and last treatment visit, patients also
undergo QST measurements. Previous trials in depression consistently reported
positive effects of treatment and no lasting side effects. In some trials,
symptoms such as dizziness and nausea are reported but they are always dose
related and pass after the treatment session. Since patients get a pain
treatment, the pain intensity might decrease during and/or after the
treatments.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69608.042.19 |
| Other | NL7606 |
| OMON | NL-OMON25538 |