- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06951763
Effect of Myofascial Release on Menstrual Pain Post Caesarean Section
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nourhan S Ibrahim, Master
- Phone Number: 01100072276
- Email: nourhansamirebrahim2025@gmail.com
Study Contact Backup
- Name: Mahitab M Yosri, PHD
- Phone Number: 01222606996
- Email: mahitab.yosri@pt.cu.edu.eg
Study Locations
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Cairo, Egypt
- Nourhan Samir Ibrahim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: stretching exercise group
The participants will receive stretching exercise program, 3 days/week for 4 weeks.
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The participants will receive stretching exercises program for 45 minutes, 3 days/week for 4 weeks.
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Experimental: stretching exercise and myofascial release group
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.
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The participants will receive stretching exercises program for 45 minutes, 3 days/week for 4 weeks.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Menstrual pain intensity measurement
Time Frame: 4 weeks
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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)
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4 weeks
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Menstruation aspects assessment
Time Frame: 4 weeks
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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.
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4 weeks
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Abdominal tenderness assessment
Time Frame: 4 weeks
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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 |
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Scar tissue mobility assessment:
Time Frame: 4 weeks
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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.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hossam Kamel, Professor, Al-Azhar University
- Study Chair: Doaa Osman, As professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005675
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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