Effects of Kegel Exercises and Myokinetic Release of Trigger Points in Primary Dysmenorrhea

January 10, 2025 updated by: Riphah International University

Effects of Kegel Exercises With and Without Myokinetic Active Release of Trigger Points on Pain, Fatigue and Quality of Life in Primary Dysmenorrhea

The rationale of this study is despite the widespread belief that exercise can reduce dysmenorrhea, evidence-based studies are limited. Studies are therefore required to evaluate the association between quality of life and the primary dysmenorrheal females, the functional impact on the quality of life and primary dysmenorrhea females also it's a crucial time for females to focus on their studies and dysmenorrhea can add to the fatigue levels and cause distress in this age group thus the purpose of this study is to determine whether myokinetic active release of trigger points in the rectus abdominis, gluteus medius and quadratus lumborum is a more effective way to reduce dysmenorrhea than kegel exercises

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Existing research may concentrate on specific interventions or populations, leaving a void in our knowledge of the possible synergistic effects of various exercises when done both alone and in combination, Studies have provided that dysmenorrhea is treated with pelvic floor strengthening however, there is little evidence that myokinetic involvement can lead to progressive outcomes. Given the interdependence of physiology, anatomy and dysfunction. Myokinetic trigger point release may be helpful in promoting the recovery of primary dysmenorrhea.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 53201
        • Recruiting
        • Major balqees maternity home
        • Contact:
        • Sub-Investigator:
          • omaima khan, mswhpt
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Major Balqees Maternity Home Clinic
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 17-25 years
  • Diagnosed cases of dysmenorrhea
  • Subject having trigger point in rectus abdominins, quadratus lumborum and gluteus medius
  • With regular cycles 21-35 days lasting 3-7 days

Exclusion Criteria:

  • Oral contraceptives used for menstrual irregularity
  • Other gynecological disease like fibroids, endometriosis
  • Who take analgesia
  • Endometrial polyp, having pelvic infection using IUD, having venous congestion in internal genital organs.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A
Kegel exercises and Myokinetic active release of trigger points
Other: Kegel exercises
It consists of 25 patients who will receive Kegel exercises with Myokinetic active release of trigger points in quadratus lumborum, rectus abdominis and gluteus medius. Patient will be in lying position with empty bladder. Ask patient to tight pelvic floor muscle group and hold tight from 3-5 seconds Then relax muscle group from 3-5 seconds with Myokinetic therapy targeted at releasing muscle of quadratus lumborum, rectus abdominis and gluteus medius release was applied passively by sustained pressure for 8-10 seconds. This protocol consisted of three sets with 2 minutes of rest..Participants will be asked to perform exercise 30 times each session following hold and relax of muscle group for 3-5 seconds
Other Names:
  • myokinetic active release of trigger points
  • kegel exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain is assessed by numerical pain rating scale
Time Frame: at baseline pre intervention, at the end of 8 week post intervention
11 point numeric pain rating scale
at baseline pre intervention, at the end of 8 week post intervention
FSS scale is used to access fatigue severity
Time Frame: at baseline pre intervention, at the end of 8 week post intervention
9 items scale
at baseline pre intervention, at the end of 8 week post intervention
SF-36 is used to access quality of life
Time Frame: at baseline pre intervention, at the end of 8 week post intervention
8 domains with further items
at baseline pre intervention, at the end of 8 week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Iqra abdul ghafoor, PPDPT, riphah international univrsity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Gupta S, Arora M, Yadav PJRJoMS. Comparative Evaluation of Effectiveness of Pelvic Floor Strengthening and Myokinetic Active Release of Trigger Points in Reducing Dysmenorrhea. 2023;13(3) 2. Rani M, Kaushal K, Kaur S. Prevalence of Musculoskeletal Pain and Awareness of Physiotherapy in Primary Dysmenorrhea among Female Students of Adesh University, Bathinda

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Riphah uni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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