Five challenges for manual therapies trials with placebo controls: A proposal

D’Alessandro, Giandomenico; Ruffini, Nuria; Iacopini, Alessio; Annoni, Marco; Kossowsky, Joe; Cerritelli, Francesco

doi:10.1016/j.ijosm.2022.08.002

Cited by 3 publications

(2 citation statements)

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“…Still, in future studies, the intervention providers and outcome assessors should be separated, and the outcome assessors should be blinded. In detail, manual therapists must necessarily be aware of the intervention they apply with their hands [84]. Lastly, the statistical methods may be extended to consider between-group differences at the post-intervention stage in future studies.…”

Section: Methodological Limitationsmentioning

confidence: 99%

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Does Osteopathic Heart-Focused Palpation Modify Heart Rate Variability in Stressed Participants with Musculoskeletal Pain? A Randomised Controlled Pilot Study

Liem,

Bohlen,

Jung

et al. 2024

Healthcare

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Heart rate variability (HRV) describes fluctuations in time intervals between heartbeats and reflects autonomic activity. HRV is reduced in stressed patients with musculoskeletal pain and improved after osteopathic manipulative treatment and mind–body interventions. Heart-focused palpation (HFP) combines manual and mind–body approaches to facilitate relaxation. This randomised controlled pilot study investigated the feasibility and sample size for a future randomised controlled trial and the effect of a single treatment with HFP or sham HFP (SHAM) on short-term HRV. A total of Thirty-three adults (47.7 ± 13.5 years old) with stress and musculoskeletal pain completed the trial with acceptable rates of recruitment (8.25 subjects per site/month), retention (100%), adherence (100%), and adverse events (0%). HFP (n = 18), but not SHAM (n = 15), significantly increased the root mean square of successive RR interval differences (p = 0.036), standard deviation of the NN intervals (p = 0.009), and ratio of the low-frequency to high-frequency power band (p = 0.026). HFP and SHAM significantly decreased the heart rate (p < 0.001, p = 0.009) but not the stress index and ratio of the Poincaré plot standard deviation along and perpendicular to the line of identity (p > 0.05). A power analysis calculated 72 participants. Taken together, the study was feasible and HFP improved HRV in stressed subjects with musculoskeletal pain, suggesting a parasympathetic effect.

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Section: Methodological Limitationsmentioning

confidence: 99%

“…Participants and statisticians were blinded to the conditions, but not the investigators (being therapists and assessors). Notably, therapists cannot be blinded in manual therapy trials because they are necessarily aware of the technique they apply with their hands (double-blinding is not achievable) [84].…”

Section: Blindingmentioning

confidence: 99%