Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.

ABSTRACT:

Background

Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.

Methods

Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.

Results

At present, 48 subjects have been randomized and completed the

SUBMITTER: Steffen AD 

PROVIDER: S-EPMC7529889 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature