Primary DysmenorrheaNCT06777940
Effects of Kegel Exercises and Myokinetic Release of Trigger Points in Primary Dysmenorrhea
A study testing Kegel exercises in people with Primary Dysmenorrhea, run by Riphah International University at 2 sites in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 17 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Kegel exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPakistan
- Study dates
- 23 Dec 2023to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Major balqees maternity home
Lahore, Punjab Province, 53201
iqra abdul ghafoor, ppdpt, 03216414266, iqra.ghafoor@riphah.edu.pk
omaima khan, mswhpt
- Recruiting
Major Balqees Maternity Home Clinic
Lahore, Punjab Province
Iqra abdul ghafoor, ppdpt, 03216414266, iqra.ghafoor@riphah.edu.pk
About this study
Official title: 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
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Kegel exercises
- Keywords
- trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel exercisesOther
Also called myokinetic active release of trigger points, kegel exercise
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
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Kegel exercises and Myokinetic active release of trigger points Receives: Other: Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain is assessed by numerical pain rating scale
11 point numeric pain rating scale
Measured: at baseline pre intervention, at the end of 8 week post intervention
FSS scale is used to access fatigue severity
9 items scale
Measured: at baseline pre intervention, at the end of 8 week post intervention
SF-36 is used to access quality of life
8 domains with further items
Measured: at baseline pre intervention, at the end of 8 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start23 Dec 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqra abdul ghafoor, PPDPT, Principal investigator, riphah international univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777940
- Sponsor's protocol ID
- Riphah uni
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kegel Exercises With and Without Myokinetic Active Release of Trigger Points on Pain, Fatigue and Quality of Life in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06777940
- Acronym / sponsor ID
- Riphah uni
- Conditions
- Primary Dysmenorrhea
- Keywords
- trigger points
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: Kegel exercisesKegel exercises and Myokinetic active release of trigger points |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kegel exercisesAlso: myokinetic active release of trigger points, kegel exerciseIt 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 | group A |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Background1. 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
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
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Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iqra abdul ghafoor, PPDPT principal investigator
riphah international univrsity
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel exercises in people with Primary Dysmenorrhea, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran NA amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain is assessed by numerical pain rating scale (time frame: at baseline pre intervention, at the end of 8 week post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06777940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.