Development of Protocols for Randomized Sham-Controlled Trials of Complex Treatment Interventions: Japanese Acupuncture for Endometriosis-Related Pelvic Pain

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Abstract
Background: Very little research has been conducted in the West to evaluate the clinical efficacy of Japanese acupuncture (JA). The characteristics that define and differentiate JA from Chinese acupuncture styles add specific challenges to the operationalization of treatment protocols for use in clinical trials. Objectives: To develop an ecologically valid and viable multimodal treatment intervention, including active and sham protocols, for use in a pilot randomized sham-controlled trial of a style of JA in treating endometriosis-related chronic pelvic pain in adolescents and young women. Methods: A focus group format was used to systematize the diagnostic framework, operationalize the intake, design the treatment protocols, and develop a viable and effective sham acupuncture intervention using the Streitberger device and sham moxibustion. Implementation of the treatment protocol employed the manualization process to provide flexibility of treatment while assuring replicability and standardization. Setting: The Japanese Acupuncture Department at the New England School of Acupuncture in Newton, MA. Results: Completed study visit forms indicated good compliance of study practitioners with active and sham treatment protocols. The specific JA protocols used in our pilot study were well tolerated by the adolescent girls who participated in the trial. No serious adverse events were reported by any participants. Our protocols were successful in maintaining patient blinding and minimizing differences in outcome expectations between treatment groups. Conclusions: Manualization provided a viable method for conforming to the interactive nature of JA treatments, yet facilitated compliance with a replicable treatment protocol. Sham controls of complex, multicomponent JA interventions pose unique challenges. The modified Streitberger needle in conjunction with sham moxibustion showed promise as a viable control in clinical trails of JA; both components of this sham protocol require further validation.