Clinical trial NCT01582724: Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone
Official title: Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Pain
Keywords: Menstrual pain
Primary dysmenorrhea
Self-care acupressure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2012-04-23
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)
timeFrame: 3rd menstruation after therapy start
Secondary outcomes:
measure: Worst pain intensity (NRS)
timeFrame: Baseline, after the 1., 2., 3. and 6. menstruation
measure: Duration of pain
timeFrame: Baseline, after the 1., 2., 3. and 6. menstruation
measure: Responder rate defined as 50% pain reduction at the days of pain
timeFrame: Baseline, after the 1., 2., 3. and 6. menstruation
measure: Sick leave days
timeFrame: Baseline, after the 1., 2., 3. and 6. menstruation
measure: Adverse effects
timeFrame: After 1., 2., 3. and 6. menstruation
measure: Days with medication intake
timeFrame: Baseline, after the 1., 2., 3. and 6. menstruation
measure: Bodily self-efficacy
timeFrame: Baseline, after 1.,2.,3. and 6. menstruation
measure: Credibility of the intervention
timeFrame: After 3. menstruation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center
Study officials:
affiliation: Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.