Self-care acupressure against dysmenorrhea (AKUD) - an app-based randomized pragmatic trial

Self-care acupressure against dysmenorrhea (AKUD) - an app-based randomized pragmatic trial

 

Primary dysmenorrhea is with an estimated prevalence of 50-90% on of the most common problem among girls and young women and one of the main reason of short term school or work absence. Acupuncture and acupressure are non-drug therapies that have been shown successful in the treatment of dysmenorrhea in a few studies. Compared with acupuncture, acupressure offers the possibility of self-care treatment. However, studies from western countries investigating self-care acupressure against menstrual pain are limited in numbers and quality.
The aim of the current study is to evaluate whether additional self-care acupressure is superior to usual care alone in the reduction of menstrual pain in women aged 18-25 years.
Approximately 220 women aged 18-25 years with menstrual pain of at least 6 measured by a numeric rating scale (0-10) at their last menstruation cycle before assessment will be included in the study and randomized in two groups (Acupressure, usual care alone as waiting list). Women in the acupressure group will receive a personal training on "how to apply self-care acupressure". Additionally they will receive an App, which will lead them through the self-care acupressure during and shortly before menstruation.
Outcome measurement will be done at baseline with a questionnaire in paper form and after the 1., 2., 3. and 6. menstruation cycle with an electronic questionnaire provided by an App. Moreover participants will fill-out an electronic diary provided by an App.
Primary outcome is the average pain intensity at the days of pain at the 3rd cycle after therapy start. Secondary outcome parameters are worst pain intensity, duration of pain, sick leave days, pain medication intake.

Publication:

Blödt S, Schuetzler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Müller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt C. Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone using stakeholder engagement to design a pragmatic randomized trial and study protocol. Trials, 2013. 14:99.

Principle investigator:
Witt, MD, MBA

Project coordinator:
Blödt

Research associate:
Pach, MD
Eisenhart-Rothe
Huang
Brinkhaus, MD

Statistics:
Roll, PhD

Data management:
Icke

Study nurse:
Eden

Project duration:
2011-2016

Project status:
publication phase

Funding:
Investigator Initiated Trial
Carstens Foundation