Do osteopathic treatments have significant effects on the intensity and duration of pain in women with primary dysmenorrhea? A randomized controlled trial for the osteopathy

Not Applicable

• Conditions: N94.4; Primary dysmenorrhoea

• Registration Number: DRKS00007619
• Lead Sponsor: Praxis für Osteopathische Medizin Plathner

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Study Completion: 2019-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

Female patients can be included if they are from 12 to 55 years, have a regular menstrual cycle (±10 days) and are diagnosed with primary dysmenorrhea by their general practitioner or gynecologist. They need to have a pain intensity (API) during menstruation exceeding 50% of NRS maximum (DDP) assessed by the Numeric Rating Scale (NRS)
- Voluntary participation
- Understanding and reading of the German language
- Age 12 to 55 years of age
- Existing menstruation
- Regular cycle (+/- 10 days)
- Diagnosed primary dysmenorrhea by a physician (date not older than 12 months)
- Pain intensity of at least 50% (NRS) at least one day of menstruation
- Accepting and signing the information sheet regarding careful record keeping
- Submission of the signed consent form for minors in addition, the signature of a parent or guardian

Exclusion Criteria

- contraceptives
- pregnancy
- abuse (i.e. alcohol, drugs)
- hormonal treatment of pain (must be at least 6 months ago)
- all conditions that make a medical treatment necessary, which may influence the menstrual cycle
- neurological diseases (i.e. treatment with steroids or opiates)
- secondary dysmenorrhea
- mental illness which must be treated with psychotropics

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures are pain intensity (NRS) and duration of pain. These data is recorded by using a menstrual diary. The complaints are documented during at least three cycles of menstruation. The participants in the intervention group get five osteopathical treatments. After three further menstrual cycles the participants document a last menstruation for the follow-up.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures are the amount of ingested pain medications and osteopathic dysfunctions.<br>These are captured by pill-counting in the menstrual diary as well as the documentation of osteopathic treatments.