Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone (AKUD)

Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone

The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain
• Intervention / Treatment: Procedure: Self-care acupressure at three predefined points

Detailed Description

Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
• Age: 18 to 25 years
• Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
• Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
• Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
• Written and oral informed consent
• Women must be able to complete the baseline questionnaire in paper form, the electronic questionnaire via App and a electronic diary via App.
• Presence of a Smartphone and agreement to do data entry through the App

Exclusion Criteria:

• Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
• Known or planned pregnancy in the next 8 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-care acupressure; 1	Procedure: Self-care acupressure at three predefined points; Self-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times
No Intervention: Usual care; 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)	3rd menstruation after therapy start

Secondary Outcome Measures

Outcome Measure	Time Frame
Worst pain intensity (NRS)	Baseline, after the 1., 2., 3. and 6. menstruation
Duration of pain	Baseline, after the 1., 2., 3. and 6. menstruation
Responder rate defined as 50% pain reduction at the days of pain	Baseline, after the 1., 2., 3. and 6. menstruation
Sick leave days	Baseline, after the 1., 2., 3. and 6. menstruation
Adverse effects	After 1., 2., 3. and 6. menstruation
Days with medication intake	Baseline, after the 1., 2., 3. and 6. menstruation
Bodily self-efficacy	Baseline, after 1.,2.,3. and 6. menstruation
Credibility of the intervention	After 3. menstruation

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Karl and Veronica Carstens Foundation
• Investigators: Principal Investigator: Claudia M Witt, MD, Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany

Publications and helpful links

General Publications

• Blodt S, Schutzler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Muller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt CM. 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 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 23, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Primary dysmenorrhea; Menstrual pain; Self-care acupressure
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: AKUD-12