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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

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

Praxis für Osteopathische Medizin Plathner
Maximilian Plathner
Kirchenstr. 60
24211 Preetz
Germany
Telephone:
04342 7884838
Fax:
No Entry
Contact per E-Mail
URL:
http://www.osteopathie-plathner.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Praxis für Osteopathische Medizin Plathner
Maximilian Plathner
Kirchenstr. 60
24211 Preetz
Germany
Telephone:
04342 7884838
Fax:
No Entry
Contact per E-Mail
URL:
http://www.osteopathie-plathner.de

Contact for Public Queries

Praxis für Osteopathische Medizin Plathner
Maximilian Plathner
Kirchenstr. 60
24211 Preetz
Germany
Telephone:
04342 7884838
Fax:
No Entry
Contact per E-Mail
URL:
http://www.osteopathie-plathner.de

Principal Investigator

Praxis für Osteopathische Medizin Plathner
Maximilian Plathner
Kirchenstr. 60
24211 Preetz
Germany
Telephone:
04342 7884838
Fax:
No Entry
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)

Praxis für Osteopathische Medizin Plathner
Kirchenstr. 60
24211 Preetz
Germany
Telephone:
04342 7884838
Fax:
No Entry
Contact per E-Mail
URL:
http://www.osteopathie-plathner.de

Institutional budget, no external funding (budget of sponsor/PI)

Praxis für Osteopathie Lars Wolf
Nebenhofstr. 7
23558 Lübeck
Germany
Telephone:
0451 / 85 808
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Forschungskommission DER OSTEOPATHEN DEUTSCHLANDS (EKO)Akademie für Osteopathie e.V. (AFO) [ETHIKKOMMISSION DER OSTEOPATHEN DEUTSCHLANDS (EKO) ]
Römerschanzweg 5
82131 Gauting
Germany
Telephone:
089 / 893 400 68
Fax:
No Entry
Contact per E-Mail
URL:
https://www.osteopathie-akademie.de/ueber-uns/die-forschungskommission/

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
UTN (Universal Trial Number):
No Entry
EUDAMED 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

Study protocols:
Prüfplan
Study abstract:
Abstract
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

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