NCT06951763

Brief Summary

The purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

    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.

    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

    4 weeks

Secondary Outcomes (1)

  • Scar tissue mobility assessment:

    4 weeks

Study Arms (2)

stretching exercise group

ACTIVE COMPARATOR

The participants will receive stretching exercise program, 3 days/week for 4 weeks.

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.

Other: stretching exrciseOther: myofascial release

Interventions

The participants will receive stretching exercises program for 45 minutes, 3 days/week for 4 weeks.

stretching exercise and myofascial release groupstretching exercise group

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.

stretching exercise and myofascial release group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nourhan Samir Ibrahim

Cairo, Egypt

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hossam Kamel, Professor

    Al-Azhar University

    STUDY DIRECTOR
  • Doaa Osman, As professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Nourhan S Ibrahim, Master

CONTACT

Mahitab M Yosri, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

April 30, 2025

Primary Completion

July 31, 2025

Study Completion

August 15, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations