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

Menstrual Pain Clinical Trial

— AKUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582724
• Other study ID #: AKUD-12
• Status: Completed
• Phase: N/A
• First received: April 18, 2012
• Last updated: August 3, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Menstrual Pain

Intervention

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

Locations

Country	Name	City	State
Germany	Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Karl and Veronica Carstens Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)		3rd menstruation after therapy start	No
Secondary	Worst pain intensity (NRS)		Baseline, after the 1., 2., 3. and 6. menstruation	No
Secondary	Duration of pain		Baseline, after the 1., 2., 3. and 6. menstruation	No
Secondary	Responder rate defined as 50% pain reduction at the days of pain		Baseline, after the 1., 2., 3. and 6. menstruation	No
Secondary	Sick leave days		Baseline, after the 1., 2., 3. and 6. menstruation	No
Secondary	Adverse effects		After 1., 2., 3. and 6. menstruation	Yes
Secondary	Days with medication intake		Baseline, after the 1., 2., 3. and 6. menstruation	No
Secondary	Bodily self-efficacy		Baseline, after 1.,2.,3. and 6. menstruation	No
Secondary	Credibility of the intervention		After 3. menstruation	No