Effectiveness of osteopathic treatment complementary to current therapy (usual care) on the impairment of quality of life in women with primary dysmenorrhea.
- Conditions
- N94.4Primary dysmenorrhoea
- Registration Number
- DRKS00032085
- Lead Sponsor
- Akademie für Osteopathie e.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br>