Menstrual PainNCT06951763
Effect of Myofascial Release on Menstrual Pain Post Caesarean Section
A study testing stretching exrcise and myofascial release in people with Menstrual Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Menstrual Pain
- What is being tested?
- stretching exrcise and myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 15 Aug 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women complaining of menstrual pain post - caesarean section (CS).
- Their age will range from 20 to 35 years.
- Their body mass index will range from 20-30 kg/m2.
- Women who gave birth once or twice.
- Women who had C-section 6 weeks to 6 months ago.
Who cannot join
- Active infection/ infectious skin disease, burn or scars.
- Less than six weeks after CS.
- Any abdominal surgeries other than CS.
- Any spinal deformity as scoliosis or kyphosis.
- History of cancer or radiation to the abdominopelvic region.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section.
Read the detailed description
Egypt has the highest cesarean section (CS) rate that has increased from 20% in 2005 to 52% in 2014. This exceptionally high CS rate without a corresponding improvement in maternal and child mortality suggests that although CS is available for populations at risk, numbers of medical unjustified CSs are on the rise.
The CS scar is assumed to be related to adverse clinical gynecological symptoms such as intermenstrual bleeding, dysmenorrhea, dyspareunia and chronic pelvic pain.The incidence of postpartum dysmenorrhea was significantly higher in the cesarean section delivery than in the vaginal delivery.
Cesarean scars have direct links to the perineal fascia and its connection with the transversalis fascia. These scars can interfere with fascial load distribution, which create adhesions to neighboring tissues, the abdominal and pelvic viscera and surrounding anatomical structures are then potentially disrupted, causing inadequate nutrition and inappropriately distributed tension among the various structures affected.
Fascial restrictions obviously decrease blood flow by vascular compression. When the dermis and fasciae are affected by a scar, the sliding structure of the fasciae is altered and when the scar tissues are not capable of adapting to the new stressor, their function is impaired.
MFR procedure lead to vasodilation by increasing capillary permeability. MFR directs force to fascial fibroblasts, as well as indirect strains applied to nerves, blood vessels, the lymphatic system and muscles. There is lacking of studies at this point, so the aim of the study is to investigate the effect of myofascial release on menstrual pain post CS.
- Conditions
- Menstrual Pain
- Being tested
- stretching exrcise, myofascial release
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stretching exrciseOther
The participants will receive stretching exercises program for 45 minutes, 3 days/week for 4 weeks.
myofascial releaseOther
The participants will receive the same stretching exercises program in addition to myofascial release of cesarean scar, abdominal fascia, diaphragm and psoas muscle for 30 minutes session twice a week for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| stretching exercise group | Active comparator | The participants will receive stretching exercise program, 3 days/week for 4 weeks. Receives: Other: stretching exrcise |
| stretching exercise and myofascial release group | Experimental | The participants will receive same stretching exercises program in addition to myofascial release of cesarean scar, for 30 minutes session twice a week for two weeks. Receives: Other: stretching exrcise; Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual pain intensity measurement
The pain level of each subject will be assessed during menstruation before participation and after the end of the procedure using the visual analogue scale (VAS) by marker across 100 mm line, Participants were asked to put a mark on the line that they felt represented the most severe pain that experienced during menstruation. The following cut points on the pain VAS will be done: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: 4 weeks
Menstruation aspects assessment
Assessment will be done by WaLIDD questionnaire that included 1) number of anatomical pain locations, 2) Wong-Baker pain range, 3) number of days of pain during menstruation, 4) frequency of disabling pain to perform their activities, e Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points (Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea.
Measured: 4 weeks
Abdominal tenderness assessment
Assessment of abdominal tenderness will be done by using the pressure algometer on day 1 and day 3 of menstruation. A one cm2 pressure probe will be positioned perpendicularly to the skin and pressed at a rate of 30kPa/s on specific PPT marked point on the abdomen around the umbilical scar and lumbar region as follows: Two measurements 4cm from the umbilicus, bilaterally (points I and II), two other measurements 4cm below the previous ones (points III and IV), a single measurement 4cm from the lower margin of the umbilicus (point V) and another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI).
Participants will be instructed to say "now" when they first felt pain due to the increased pressure. At this point, the algometer will immediately stop and automatically record the amount of pressure applied. Two measures will be collected for each area, with 30s between points testing
Measured: 4 weeks
Secondary outcomes (1)
Scar tissue mobility assessment:
The adherometer will be used to measure scar mobility before and after the procedure for each woman in both groups. An adherometer is a clear plastic sheet with concentric circles, with good reliability on measuring tissue mobility of C-section scars in superior, inferior, left and right directions. Participants will lay supine on a plinth with arms at their sides and legs straight. Marks will be made on the CS scar at 2.5 centimeter (cm) intervals using ruler. The examiner will use the marks to measure tissue extensibility in millimeters (mm) in all four directions.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan samir Ibrahim, Cairo University
- Investigators
- Hossam Kamel, Professor, Study director, Al-Azhar UniversityDoaa Osman, As professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951763
- Sponsor's protocol ID
- P.T.REC/012/005675
- Status last verified
- Apr 2025
- First submitted
- 23 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release on Menstrual Pain Post Caesarean Section
- ClinicalTrials.gov ID
- NCT06951763
- Acronym / sponsor ID
- P.T.REC/012/005675
- Conditions
- Menstrual Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 30 Apr 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 purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section.
Detailed description
Egypt has the highest cesarean section (CS) rate that has increased from 20% in 2005 to 52% in 2014. This exceptionally high CS rate without a corresponding improvement in maternal and child mortality suggests that although CS is available for populations at risk, numbers of medical unjustified CSs are on the rise.
The CS scar is assumed to be related to adverse clinical gynecological symptoms such as intermenstrual bleeding, dysmenorrhea, dyspareunia and chronic pelvic pain.The incidence of postpartum dysmenorrhea was significantly higher in the cesarean section delivery than in the vaginal delivery.
Cesarean scars have direct links to the perineal fascia and its connection with the transversalis fascia. These scars can interfere with fascial load distribution, which create adhesions to neighboring tissues, the abdominal and pelvic viscera and surrounding anatomical structures are then potentially disrupted, causing inadequate nutrition and inappropriately distributed tension among the various structures affected.
Fascial restrictions obviously decrease blood flow by vascular compression. When the dermis and fasciae are affected by a scar, the sliding structure of the fasciae is altered and when the scar tissues are not capable of adapting to the new stressor, their function is impaired.
MFR procedure lead to vasodilation by increasing capillary permeability. MFR directs force to fascial fibroblasts, as well as indirect strains applied to nerves, blood vessels, the lymphatic system and muscles. There is lacking of studies at this point, so the aim of the study is to investigate the effect of myofascial release on menstrual pain post CS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stretching exercise group | Active comparator | Other: stretching exrciseThe participants will receive stretching exercise program, 3 days/week for 4 weeks. |
| stretching exercise and myofascial release group | Experimental | Other: stretching exrcise, Other: myofascial releaseThe participants will receive same stretching exercises program in addition to myofascial release of cesarean scar, for 30 minutes session twice a week for two weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women complaining of menstrual pain post - caesarean section (CS).
- Their age will range from 20 to 35 years.
- Their body mass index will range from 20-30 kg/m2.
- Women who gave birth once or twice.
- Women who had C-section 6 weeks to 6 months ago.
Key exclusion criteria (5 listed)
- Active infection/ infectious skin disease, burn or scars.
- Less than six weeks after CS.
- Any abdominal surgeries other than CS.
- Any spinal deformity as scoliosis or kyphosis.
- History of cancer or radiation to the abdominopelvic region.
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 |
|---|---|---|
| stretching exrciseThe participants will receive stretching exercises program for 45 minutes, 3 days/week for 4 weeks. | Other | stretching exercise and myofascial release group, stretching exercise group |
| myofascial releaseThe participants will receive the same stretching exercises program in addition to myofascial release of cesarean scar, abdominal fascia, diaphragm and psoas muscle for 30 minutes session twice a week for two weeks. | Other | stretching exercise and myofascial release group |
Primary outcome
Menstrual pain intensity measurement
Time frame: 4 weeks
The pain level of each subject will be assessed during menstruation before participation and after the end of the procedure using the visual analogue scale (VAS) by marker across 100 mm line, Participants were asked to put a mark on the line that they felt represented the most severe pain that experienced during menstruation. The following cut points on the pain VAS will be done: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Menstruation aspects assessment
Time frame: 4 weeks
Assessment will be done by WaLIDD questionnaire that included 1) number of anatomical pain locations, 2) Wong-Baker pain range, 3) number of days of pain during menstruation, 4) frequency of disabling pain to perform their activities, e Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points (Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea.
Abdominal tenderness assessment
Time frame: 4 weeks
Assessment of abdominal tenderness will be done by using the pressure algometer on day 1 and day 3 of menstruation. A one cm2 pressure probe will be positioned perpendicularly to the skin and pressed at a rate of 30kPa/s on specific PPT marked point on the abdomen around the umbilical scar and lumbar region as follows: Two measurements 4cm from the umbilicus, bilaterally (points I and II), two other measurements 4cm below the previous ones (points III and IV), a single measurement 4cm from the lower margin of the umbilicus (point V) and another single measurement into the medial side of the lumbar region below the fifth lumbar vertebra, corresponding to S2-S4 (point VI). Participants will be instructed to say "now" when they first felt pain due to the increased pressure. At this point, the algometer will immediately stop and automatically record the amount of pressure applied. Two measures will be collected for each area, with 30s between points testing
1 secondary outcome
Scar tissue mobility assessment:
Time frame: 4 weeks
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 30 Apr 2025.
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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.
Hossam Kamel, Professor study director
Al-Azhar University
Doaa Osman, As professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stretching exrcise and myofascial release in people with Menstrual Pain, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Nourhan S Ibrahim, Master (01100072276, nourhansamirebrahim2025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual pain intensity measurement (time frame: 4 weeks). 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?
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 30 Apr 2025.