- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254510
The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
April 20, 2020 updated by: esra pehlivan, Istanbul Medipol University Hospital
The Effect of Myofascial Relaxation Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Dysmenorrhea is a series of pathological symptoms associated with menstruation that interfere with daily activities such as abdominal cramps and pain in the menstrual period.
General symptoms such as nausea, vomiting, lumbago, diarrhea and headache are also common.
Primary dysmenorrhea refers to menstrual pain that does not depend on the underlying pathology.
The kidneys act on the fascia of the psoas muscle.
If the psoas muscle does not shorten and grow sufficiently, the kidneys may not move for a certain period of time and may experience ptosis.
This causes venous ponding and may cause varicocele in men and primary dysmenorrhea in women.
Techniques to be applied directly to the fascia of the psoas muscle can reduce symptoms of dysmenorrhea in women.
In the literature review, no studies investigating the effectiveness of a treatment applied directly and only on the psoas muscle on primary dysmenorrhea were not found.
This study can set an example for future studies.
In our study, myofascial relaxation technique will be applied in women with primary dysmenorrhoea and its effect on pain will be examined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Üsküdar
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İstanbul, Üsküdar, Turkey, 34668
- Esra Pehlivan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- The age range is 18-30,
- Intense pain compared to visual analog scale in the lower region of the abdomen during or just before the menstruation period (> 4),
- No pregnancy history,
- Not using drugs for dysmenorrhea symptoms
Exclusion Criteria:
- Not agreeing to participate in the study,
- Endometriosis, ovarian cyst, uterine fibroid, congenital malformation or pelvic inflammation,
- Having a diagnosis of secondary dysmenorrhea
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
|
Experimental: Study Group
Myofascial relaxation technique
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: 5 seconds
|
Pain intensity will be questioned by scale.For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) .
To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended
|
5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Tülay Ülkü Sevim, Saglik Bilimleri Universitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2020
Primary Completion (Actual)
April 3, 2020
Study Completion (Actual)
April 20, 2020
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
April 21, 2020
Last Update Submitted That Met QC Criteria
April 20, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRT_Dysmenorrhea
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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