NCT04359381

Brief Summary

Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 20, 2020

Last Update Submit

April 21, 2020

Conditions

Keywords

kinesiotapingpilate exercisesprimary dysmenorrhea

Outcome Measures

Primary Outcomes (1)

  • Weight and height scale

    Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2

    three months

Secondary Outcomes (1)

  • Visual analog scale

    three months

Study Arms (2)

kinesiotaping

EXPERIMENTAL

by kinesiotaping during menstruation for 3 successive menstruation

Other: kinesiotaping application

pilate exercises

EXPERIMENTAL

pilate exercises, 3 sessions per week for 3 months

Other: Pilate exercises program

Interventions

kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.

kinesiotaping

Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .

pilate exercises

Eligibility Criteria

Age14 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Their ages ranged from 14 to 20 years old
  • their body mass index (BMI) would be less than 25 Kg/m2
  • having primary dysmenorrhoea

You may not qualify if:

  • skin diseases or cardiac diseases
  • irregular or infrequent menstrual cycles
  • previous abdominal or back operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghada Elrefaye

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

DysmenorrheaMotor Activity

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsBehavior

Study Officials

  • ghada eb elrefaye, professor

    Assistant Professor of Physical Therapy for Woman's Health, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
An independent person randomly assigned to all participated subjects to either group (A) (n=30) or group (B) (n=30) by chosen numbers from closed envelopes having numbers that the number generator were chosen randomly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was designed as a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

December 24, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations