Samenvatting
Methods: This trial was an international multicenter, randomized controlled pilot study. Patients at age ≥ 65 years with musculoskeletal pain for 3 months and a daily pain score ≥ 4 out of 10 were recruited at three centers. They were ≥randomized to receive either a combination of music and low-frequency (20–100 Hz) vibrations administered to the abdomen, or a combi- nation with the same music but with higher frequency (200–300 Hz) vibrations administered to the abdomen. Low-frequency vibrations were expected to result in pain reduction mea- sured with a numeric pain rating scale (NRS). Patients in both groups received eight treat- ments of the music combined with the vibrations in three weeks. Primary outcomes were safety (Serious Adverse Events) and pain intensity measured at baseline, after the last treat- ment and at six weeks follow-up. Multilevel linear model analyses were performed to study group and time effects.
Results: A total of 45 patients were analyzed according to intention-to-treat principle. After 344 treat- ments, 1 Adverse Event was found related to the intervention, while 13 Adverse Events were possibly related. A multilevel linear model showed that the interaction effect of group by time did not predict pain intensity (F[1, 45.93] = 0.002, p = 0.97) when comparing pain intensity at baseline, after the last treatment and at follow-up.
Conclusions
The combination of music and abdominally administered vibrations was found to be safe and well tolerated by the elderly patients. However, over time, neither the low-frequency treatment group nor the high-frequency treatment group provided clinically meaningful pain relief. There is no evidence that the low-frequency treatment elicited vagal nerve stimulation.
Trial registration
The trial was prospectively registered in the Netherlands Trial Register (NTR: NL7606) on 21-03-2019.
Originele taal-2 | English |
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Artikelnummer | e0259394 |
Aantal pagina's | 16 |
Tijdschrift | PLoS ONE |
Volume | 16 |
Nummer van het tijdschrift | 11 |
DOI's | |
Status | Published - 2-nov.-2021 |