Randomized Controlled Study
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Katharine J. Bar ◽  
Pamela A. Shaw ◽  
Grace H. Choi ◽  
Nicole Aqui ◽  
Andrew Fesnak ◽  

2021 ◽  
Jianxiong Cai ◽  
Lin Dai ◽  
Lingjia Yin ◽  
Taoying Lu ◽  
Li Wang ◽  

Abstract Background: To date, no well-recognized placebo device or procedure for pediatric Tuina (PT) has been reported. We developed a cloak-shaped device and designed an RCT to detect whether the device is effective as a placebo in PT research.Methods: It was a two-arm, parallel-group RCT design. Children were randomly assigned to the genuine Tuina or sham Tuina group at a 1:1 ratio. The genuine and sham Tuina interventions were delivered using the same standardized procedure by adopting a cloak-shaped device. The primary outcomes were the judgement rates of the type of Tuina that participants received based on caregivers’ and observers’evaluations. The analysis explored whether parents' attitude towards PT was related to their judgment rate.Results: A total of 60 participants were enrolled (37 boys [61.7%]; 16.0[2.3] months). Thirty children received genuine PT, and 30 received sham PT. There was no significant difference in parents' judgment of the interventions received between the two groups (χ2=0.65,P=0.421) or based on observers' judgments (χ2=0.07, P=0.795). In terms of parents' attitude towards PT or compliance with PT, parents whose children were in the genuine Tuina group were not significantly different from those in the sham group(z=0.01, P=0.99; z=0.34, P=0.73). Of the participants in the sham group, none of their parents recorded receiving the sham intervention.Conclusions: The placebo device for sham PT was found to be a credible control for PT. This study supports its use in prospective, sham-controlled, randomized trials.Trial registration: ClinicalTrials.gov, NCT03474172. Registered in March 2018.

Anna Gabriel ◽  
Andreas Konrad ◽  
Anna Roidl ◽  
Jennifer Queisser ◽  
Robert Schleip ◽  

Prior studies have shown that self- and manual massage (SMM) increases flexibility in non-adjacent body areas. It is unclear whether this also influences performance in terms of force generation. Therefore, this study investigated the effect of SMM on the plantar surface on performance in the dorsal kinetic chain. Seventeen young participants took part in this within-subject non-randomized controlled study. SMM was applied on the plantar surface of the dominant leg, but not on the non-dominant leg. A functional performance test of the dorsal kinetic chain, the Bunkie Test, was conducted before and after the intervention. We measured the performance in seconds for the so-called posterior power line (PPL) and the posterior stabilizing line (PSL). The performance of the dominant leg in the Bunkie Test decreased significantly by 17.2% from (mean ± SD) 33.1 ± 9.9 s to 27.4 ± 11.1 s for the PPL and by 16.3% from 27.6 ± 9.8 s to 23.1 ± 11.7 s for the PSL. This is in contrast to the non-dominant leg where performance increased significantly by 5.1% from 29.7 ± 9.6 s to 31.1 ± 8.9 s for the PPL and by 3.1% from 25.7 ± 1.5 s to 26.5 ± 1.7 s for the PSL. SMM interventions on the plantar surface might influence the performance in the dorsal kinetic chain.

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