N94.4
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) Menstruation present b) Regular cycle (between 21 and 35 days) c) There must be a gynecological specialist diagnosis of primary dysmenorrhea. This must be evidenced by a written certificate. (d) Pain intensity =5 days (NRS) on at least one day of menstruation of the baseline cycle. (e) A written informed consent form must be signed. In the case of minors, the signature of a legal guardian is also required f) Sufficient knowledge of the German language
Exclusion criteria
Exclusion criteria: a) Secondary dysmenorrhea b) Pregnancy c) Abuse (alcohol, drugs, medication) d) All diseases that make medical treatment necessary and can thus influence the cycle e) Neurological diseases (e.g. treatments with steroids or opiates) f) Mental illnesses that require treatment with psychotropic drugs g) Osteopathic treatments during the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impairment of quality of life due to primary dysmenorrhea measured with the Numerical Rating Scale (NRS; e.g., 0 = no impairment to 10 = maximum impairment), retrospectively for menstruation from cycle 1 - 10. (End of study cycle 4, 1st follow-up cycle 7, 2nd follow-up cycle 10). | — |
Secondary
| Measure | Time frame |
|---|---|
| The intensity of pain and the intensity of menstruation will also be asked in the menstrual diary, which is to be kept throughout the study, using a numerical rating scale NRS, as well as the use of medication. The general quality of life is assessed using the generic SF-36 questionnaire. Side effects and osteopathic dysfunctions are recorded. | — |
Countries
Germany
Contacts
Akademie für Osteopathie e.V.