N94.4
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average intraindividual improvement in pain score after use of the device on day 1, 2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Average intraindividual improvement in pain score after use of the device (averages of all measurements) - Duration of pain relief after application of the device - Improvement of pain (VAS McGill), compared to comparison cycle - Restriction of daily life, compared to comparison cycle - Use of pain medication, compared to comparison cycle - Frequency of AEs - Frequency of use of the EM50 - Handling device (one-time day 5) | — |
Countries
Germany
Contacts
Institut Prof. Kurscheid