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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 5 December 2018
Main ID:  DRKS00007619
Date of registration: 12/12/2014
Prospective Registration: Yes
Primary sponsor: Praxis für Osteopathische Medizin Plathner
Public title: 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
Scientific title: 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
Date of first enrolment: 18/12/2014
Target sample size: 66
Recruitment status: Suspended
URL:  http://www.drks.de/DRKS00007619
Study type:  interventional
Study design:  Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment. Assignment: Parallel. Study design purpose: Treatment;  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name: Maximilian    Plathner
Address:  Kirchenstr. 60 24211 Preetz Germany
Telephone: 04342 7884838
Email: info@praxis-plathner.de
Affiliation:  Praxis für Osteopathische Medizin Plathner
Name: Maximilian    Plathner
Address:  Kirchenstr. 60 24211 Preetz Germany
Telephone: 04342 7884838
Email: info@praxis-plathner.de
Affiliation:  Praxis für Osteopathische Medizin Plathner
Key inclusion & exclusion criteria
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


Age minimum: 12 Years
Age maximum: 55 Years
Gender: Female
Health Condition(s) or Problem(s) studied
N94.4 - Primary dysmenorrhoea
Intervention(s)
Intervention 1: The participants of the intervention group will create a baseline before they start getting osteopathic tests and treatments. The baseline data will be documented during the last menstrual cycle before the beginning of the treatment period.
After that, the women get five osteopathic treatments every two or three weeks. During this time they document three menstrual cycles. After another three cycles they document a last menstruation for the follow-up. We plan to treat this women for about 45 minutes with osteopathic technics. Intervention 2: The participants of the control group will create a baseline before they start getting osteopathic tests. The control group will be untreated during the study period. The women document three menstrual cycles.There will be no follow-up in this group.
Primary Outcome(s)
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(s)
The secondary outcome measures are the amount of ingested pain medications and osteopathic dysfunctions.
These are captured by pill-counting in the menstrual diary as well as the documentation of osteopathic treatments.
Secondary ID(s)
Source(s) of Monetary Support
Bitte hier die Adresse eintragen
Osteopathiepraxis Koop
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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