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.