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Main
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Note: This record shows only 22 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. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007619 |
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Date of registration:
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12/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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18/12/2014 |
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Target sample size:
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72 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007619 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Maximilian
Plathner |
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Address:
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Kirchenstr. 60
24211
Preetz
Germany |
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Telephone:
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04342 7884838 |
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Email:
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info@praxis-plathner.de |
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Affiliation:
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Praxis für Osteopathische Medizin Plathner |
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Name:
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Maximilian
Plathner |
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Address:
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Kirchenstr. 60
24211
Preetz
Germany |
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Telephone:
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04342 7884838 |
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Email:
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info@praxis-plathner.de |
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Affiliation:
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Praxis für Osteopathische Medizin Plathner |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Primary dysmenorrhoea
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N94.4
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N94.4
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Intervention(s)
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Group 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.
Group 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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Praxis für Osteopathische Medizin Plathner
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Praxis für Osteopathie Lars Wolf
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Ethics review
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Status: Approved
Approval date: 30/11/2014
Contact:
info@osteopathie-akademie.de
Forschungskommission DER OSTEOPATHEN DEUTSCHLANDS (EKO)Akademie für Osteopathie e.V. (AFO) [ETHIKKOMMISSION DER OSTEOPATHEN DEUTSCHLANDS (EKO)
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089 / 893 400 68
info@osteopathie-akademie.de
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