Active Vibration Induced Treatment by Abdominal Excitatio

Completed

• Conditions: musculoskeletal pain; rheumatism; 10028393

• Registration Number: NL-OMON49209
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>per objective:<br /><br><br /><br>1. Safety and tolerability: (S)AE listings, UTAUT and ARTS<br /><br>2. Self-reported pain: NRS<br /><br>3. Quantitative Sensory Testing (QST)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>per objective:<br /><br><br /><br>1. Not applicable<br /><br>2. Pain disability index: PDI; Quality of life: EuroQoL 5D3L<br /><br>3. Central sensitization index: CSI</p><br>