Trial document




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  DRKS00007619

Trial Description

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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

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Trial Acronym

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URL of the Trial

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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

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007619
  •   2014/12/12
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, ETHIKKOMMISSION DER OSTEOPATHEN DEUTSCHLANDS (EKO)
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Secondary IDs

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Health Condition or Problem studied

  •   N94.4 -  Primary dysmenorrhoea
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Interventions/Observational Groups

  •   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.
  •   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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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/12/18
  •   72
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   12   Years
  •   55   Years
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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

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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

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Addresses

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    • Praxis für Osteopathische Medizin Plathner
    • Mr.  Maximilian  Plathner 
    • Kirchenstr. 60
    • 24211  Preetz
    • Germany
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    • Praxis für Osteopathische Medizin Plathner
    • Mr.  Maximilian  Plathner 
    • Kirchenstr. 60
    • 24211  Preetz
    • Germany
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    • Praxis für Osteopathische Medizin Plathner
    • Mr.  Maximilian  Plathner 
    • Kirchenstr. 60
    • 24211  Preetz
    • Germany
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Sources of Monetary or Material Support

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    • Praxis für Osteopathische Medizin Plathner
    • Mr.  Maximilian  Plathner 
    • Kirchenstr. 60
    • 24211  Preetz
    • Germany
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    • Praxis für Osteopathie Lars Wolf
    • Mr.  Lars  Wolf 
    • Nebenhofstr. 7
    • 23558  Lübeck
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/03/11
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Trial Publications, Results and other Documents

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