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The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Post Isometric Relaxation
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female aged 18 - 30 Primary Dysmenorrhea Unmarried Exclusion Criteria: Not on any contraceptive medicine for treatment of pelvic pathology Secondary Dysmenorrhea and other issues such as endometriosis, Pelvic inflammatory disease, Ovarian cyst

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Group

Arm Description

Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.

Outcomes

Primary Outcome Measures

Pain intensity
Pain will be measured using numeric pain rating scale which is an 10 point scale scored from zero indicating no pain and 10 indicating worst pain.

Secondary Outcome Measures

Quality of life of participant
Quality of life will be measured by WHOQOL-bref (World Health questionnaire for quality of life) which is valid and reliable tool for measuring quality of life with 26 instruments, Each individual item score from one to five on response scale.
WALIDD
Working ability, Location, Intensity, Days of pain, Dysmenorrhea (WALIDD) is a scale with four categories Score of each category is added to find out the total level of severity of dysmenorrhea.

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT06045169
Brief Title
The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea
Official Title
The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

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
This study will be a quasi experimental study in which females aged 18 - 30 years with primary dysmenorrhea will be recruited in single group. They will be given a total of 3 sessions of treatment during a period of one menstrual cycle (One Week). Before and after the introduction of intervention pain and quality of life of participants will be assessed.
Detailed Description
Primary Dysmenorrhea is one of the most prevalent gynecological conditions which impacts the quality of life of young females.Primary dysmenorrhea is defined as cramping like pain during menstruation cycle without the presence of any pelvic pathology it is associated with symptoms like headache,vomitting and irritability.The aim of our study is to determine the effects of muscle energy technique in young females with primary dysmenorrhea in terms of pain and quality of life.This study will be a Quasi Experimental study.It will be conducted at Foundation university college of physical therapy.Paticipants will complete WALIDD scale,NPRS and WHOQOL at baseline and then after intervention.All participants will receive post isometric relaxation of global muscles of core commonly involved in primary dysmenorrhea(Gluteus Maximus,Illiopsoas and Piriformis).Post isometric relaxation technique will be applied to all the participants with participants using 20% of their maximum voluntary contractio with held time of 6-10 seconds followed by 15 to 30 seconds stretch,rest time of 5 seconds between each repetitions and 3-5 repetions.There will be a total of 3 sessiond of treatment(1st on second day of menstruation,2nd on fourth day of menstruatio and 3rd on seventh day of menstruation)during a period of one week (one menstraul cycle).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi Experimental Pre-test Post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Group
Arm Type
Other
Arm Description
Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.
Intervention Type
Procedure
Intervention Name(s)
Post Isometric Relaxation
Intervention Description
Post isometric relaxation with participants using 20% of their maximum voluntary contraction will be given to global muscles of core commonly involved in primary dysmenorrhea glutus maximus, Illiopsoas and pirifirmis. Post isometric contraction will be held for 6 to 10 seconds followed by 15 o 30 seconds stretch, rst time will be 5 seconds in between repetations and number of repetations will be 3-5.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain will be measured using numeric pain rating scale which is an 10 point scale scored from zero indicating no pain and 10 indicating worst pain.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Quality of life of participant
Description
Quality of life will be measured by WHOQOL-bref (World Health questionnaire for quality of life) which is valid and reliable tool for measuring quality of life with 26 instruments, Each individual item score from one to five on response scale.
Time Frame
1 week
Title
WALIDD
Description
Working ability, Location, Intensity, Days of pain, Dysmenorrhea (WALIDD) is a scale with four categories Score of each category is added to find out the total level of severity of dysmenorrhea.
Time Frame
1 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female between ages 18-30 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female aged 18 - 30 Primary Dysmenorrhea Unmarried Exclusion Criteria: Not on any contraceptive medicine for treatment of pelvic pathology Secondary Dysmenorrhea and other issues such as endometriosis, Pelvic inflammatory disease, Ovarian cyst
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea

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