- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06045169
The Effects of Muscle Energy Techniques on Pain and Quality of Life in Young Females With Primary Dysmenorrhea
September 13, 2023 updated by: Foundation University Islamabad
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Estimated)
30
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
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Foundation University College of Physical Therapy
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 1 week
|
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.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life of participant
Time Frame: 1 week
|
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.
|
1 week
|
|
WALIDD
Time Frame: 1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 15, 2023
Primary Completion (Estimated)
September 20, 2023
Study Completion (Estimated)
February 10, 2024
Study Registration Dates
First Submitted
September 13, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2023/15
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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