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
Organizational Data
- DRKS-ID:
- DRKS00007619
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-12-12
- Last update in DRKS:
- 2021-02-16
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Do osteopathic treatments have significant effects on the intensity and duration of pain in women with painful menstruation? A randomized controlled trial for the osteopathy
Brief summary in scientific language
Do osteopathic treatments have significant effects on the intensity and duration of pain in women with primary dysmenorrhea? We will investigate the effectiveness of a series of five osteopathic treatments in patients with pain due to primary dysmenorrhea. This is a multi-centered randomized controlled trial with an osteopathic intervention group and an untreated (“waiting list”) control group. We plan to include 72 women from 12 to 55 years, with a regular menstrual cycle and diagnosed with primary dysmenorrhea. We plan five osteopathic treatments over a period of three menstrual cycles in the treatment group and no osteopathic treatment in the control group. At each treatment session, dysfunctional structures are going to be tested and treated based on osteopathic principles. In both groups, pain medication on demand are allowed, but the participants have to document it. Female patients can be included if they are aged 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) Patients are excluded if they use contraceptives, are pregnant, declare misuse of alcohol, drugs or medication, are treated for their pain by hormonal therapy, have illnesses that make medical treatment necessary which influence the menstrual cycle, show neurological conditions (e.g. treatment with steroids and opiates), or are diagnosed with secondary dysmenorrhea. The patients are going to be randomly allocated to two groups: an intervention group that is going to be treated osteopathically, and a control group, which is going to be untreated during the study period.
Health condition or problem studied
- ICD10:
- N94.4 - Primary dysmenorrhoea
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- 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:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Preetz
- Doctor's practice Lübeck
Recruitment period and number of participants
- Planned study start date:
- 2014-12-19
- Actual study start date:
- 2014-12-18
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-03-11
- Target Sample Size:
- 72
- Final Sample Size:
- 72
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 12 Years
- Maximum Age:
- 55 Years
- Additional 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
Addresses
Primary Sponsor
- Address:
- Praxis für Osteopathische Medizin PlathnerMaximilian PlathnerKirchenstr. 6024211 PreetzGermany
- Telephone:
- 04342 7884838
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.osteopathie-plathner.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Praxis für Osteopathische Medizin PlathnerMaximilian PlathnerKirchenstr. 6024211 PreetzGermany
- Telephone:
- 04342 7884838
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.osteopathie-plathner.de
Contact for Public Queries
- Address:
- Praxis für Osteopathische Medizin PlathnerMaximilian PlathnerKirchenstr. 6024211 PreetzGermany
- Telephone:
- 04342 7884838
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.osteopathie-plathner.de
Principal Investigator
- Address:
- Praxis für Osteopathische Medizin PlathnerMaximilian PlathnerKirchenstr. 6024211 PreetzGermany
- Telephone:
- 04342 7884838
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.osteopathie-plathner.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Praxis für Osteopathische Medizin PlathnerKirchenstr. 6024211 PreetzGermany
- Telephone:
- 04342 7884838
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.osteopathie-plathner.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Praxis für Osteopathie Lars WolfNebenhofstr. 723558 LübeckGermany
- Telephone:
- 0451 / 85 808
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Forschungskommission DER OSTEOPATHEN DEUTSCHLANDS (EKO)Akademie für Osteopathie e.V. (AFO) [ETHIKKOMMISSION DER OSTEOPATHEN DEUTSCHLANDS (EKO) ]Römerschanzweg 582131 GautingGermany
- Telephone:
- 089 / 893 400 68
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.osteopathie-akademie.de/ueber-uns/die-forschungskommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-10-16
- Ethics committee number:
- No Entry
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-11-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry