Observational study on the effectiveness of the medical device Beurer EM 50 Menstrual Relax in reducing menstrual pain associated with primary dysmenorrhoea (ReduPain)
- Conditions
- N94.4Primary dysmenorrhoea
- Registration Number
- DRKS00024411
- Lead Sponsor
- Institut Prof. Kurscheid
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 58
Inclusion Criteria
Willingness to participate in the study (Informed consent)
- Older than 18 years
- Premenopausal
- Primary dysmenorrhoea, in the lower abdomen. (VAS = 25)
- Menstruation in the last 6 weeks with a cycle length of 3 to 6 weeks.
Exclusion Criteria
- Known pregnancy
- Abdominal surgery in the last 6 months before study inclusion
- Injuries or exanthema of the abdominal wall
- Known allergies to the plastic of the EM50
- Wearing non-removable piercings
- Wearing an intrauterine device (IUD)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Average intraindividual improvement in pain score after use of the device on day 1, 2 and 3
- Secondary Outcome Measures
Name Time Method Average intraindividual improvement in pain score after use of the device (averages of all measurements)<br>- Duration of pain relief after application of the device<br>- Improvement of pain (VAS McGill), compared to comparison cycle<br>- Restriction of daily life, compared to comparison cycle<br>- Use of pain medication, compared to comparison cycle<br>- Frequency of AEs <br>- Frequency of use of the EM50 <br>- Handling device (one-time day 5)