Dysmenorrhea: A randomized controlled clinical trial evaluating a novel treatment approach

Abstract

Objective: To evaluate a new treatment for dysmenorrhea by mechanically inducing menstrual fluid streaming. Setting: A 4-month randomized double-blind, placebo-controlled, crossover study. Participants: Study participants included women experiencing dysmenorrhea monthly (for the 6 preceding months) at a level >5 on the visual analog scale (0–10), who were otherwise healthy. The study participants also collected their menstrual fluid for 2 baseline months, while recording their pain levels (primary outcome) systematically. A correlation between menstrual fluid characteristics and menstrual pain was studied as well. Intervention: A newly invented device was used to attenuate dysmenorrheic pain level. Results: From September 2011 to December 2013, 28 study participants were enrolled; three withdrew and three were excluded for protocol non-adherence. Twenty-two study participants (132 menstrual cycles) who used the device reported an average reduction of 55 ± 7.6% in pain levels vs. 22 ± 12% reported with placebo (p = 0.008). In addition, analysis of menstrual fluid collected from 19 study participants (38 menstrual cycles) showed that high pain levels necessarily involve tissue fragments or a viscous menstrual fluid, supporting the idea that dysmenorrhea is associated with the rheological characteristics of the menstrual fluid. Conclusions: The new device is highly effective in relieving menstrual pain. Rheological characteristics of the menses are correlated with severity of dysmenorrhea.

Keywords

• dysmenorrhea
• menses
• randomized trial
• rheology
• vaginal device
• actilady