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The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle

Primary Purpose

Woman; Primary Dysmenorrhoea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial relaxation technique
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Woman; Primary Dysmenorrhoea

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Esra Pehli̇van

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control group

Arm Description

Myofascial relaxation technique

Outcomes

Primary Outcome Measures

Visual analog scale
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

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
April 20, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04254510
Brief Title
The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Official Title
The Effect of Myofascial Relaxation Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Woman; Primary Dysmenorrhoea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Myofascial relaxation technique
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Myofascial relaxation technique
Intervention Description
Before the intervention, the number of days of the last menstrual cycle of all participants, the number of painful days throughout the cycle, pain intensity values according to the Visual Analogue Scale will be recorded, and the scores will be recorded in the participants. Technique of direct relaxation of fascia of both psoas muscles to the participants in the myofascial relaxation group since the end of the last cycle, 90-120 sec. It will be applied by the physiotherapist twice a week.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
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
Time Frame
5 seconds

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tülay Ülkü Sevim
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Esra Pehli̇van
City
İstanbul
State/Province
Üsküdar
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effect of Myofascial Release Technique on the Treatment of Primary Dysmenorrhea in Psoas Muscle

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