NCT04254510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

April 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 3, 2020

Last Update Submit

April 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    5 seconds

Study Arms (2)

Study Group

EXPERIMENTAL

Myofascial relaxation technique

Other: Myofascial relaxation technique

Control group

NO INTERVENTION

Interventions

* 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.

Study Group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not agreeing to participate in the study,
  • Endometriosis, ovarian cyst, uterine fibroid, congenital malformation or pelvic inflammation,
  • Having a diagnosis of secondary dysmenorrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Pehli̇van

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

Study Officials

  • Tülay Ülkü Sevim

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

February 10, 2020

Primary Completion

April 3, 2020

Study Completion

April 20, 2020

Last Updated

April 21, 2020

Record last verified: 2020-02

Locations