NCT07717983

Brief Summary

The goal of this randomized controlled clinical trial is to determine whether adding abdominopelvic fascial release to a standardized stretching exercise program is more effective than stretching exercises alone in reducing menstrual pain in women following cesarean section. The study will enroll women aged 20 to 35 years with moderate to severe dysmenorrhea after cesarean delivery. Researchers will compare the effects of abdominopelvic fascial release combined with stretching exercises with stretching exercises alone on menstrual pain and scar mobility. Participants will be randomly assigned to one of two treatment groups, undergo assessments before and after the intervention period, and receive the assigned treatment according to the study protocol.

Trial Health

65
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Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2026

Shorter than P25 for not_applicable

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

Study Progress33%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

July 16, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

July 18, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 16, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Menstrual Pain Intensity

    Menstrual pain intensity will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). The primary outcome is the change in VAS score from baseline to the end of the intervention period.

    Baseline and immediately after completion of the 4-week intervention period.

Secondary Outcomes (3)

  • Change in Cesarean Scar Mobility

    Baseline and immediately after completion of the 4-week intervention period.

  • Change in Dysmenorrhea Severity

    Baseline and immediately after completion of the 4-week intervention period.

  • Change in Pressure Pain Threshold

    Baseline and immediately after completion of the 4-week intervention period.

Study Arms (2)

Abdominopelvic Fascial Release + Stretching Exercises

EXPERIMENTAL

Participants assigned to the experimental group will receive abdominopelvic fascial release in combination with a standardized stretching exercise program. Abdominopelvic fascial release will be administered for 30 minutes per session, twice weekly for 2 weeks, and the stretching exercise program will be provided for 45 minutes per session, three sessions per week for 4 weeks.

Other: Abdominopelvic fascial Release

Stretching Exercises Alone

ACTIVE COMPARATOR

Participants assigned to the control group will receive a standardized stretching exercise program for 45 minutes per session, three sessions per week for 4 weeks.

Other: Abdominopelvic fascial Release

Interventions

Abdominopelvic fascial release is a manual therapy intervention designed to restore mobility of the abdominal and pelvic fascial tissues by applying sustained, low-load pressure to fascial restrictions. The treatment targets the cesarean scar, abdominal fascia, diaphragm, and psoas muscle to improve fascial mobility, reduce tissue restrictions, alleviate pain, and enhance tissue function. The intervention will be administered for 30 minutes per session, twice weekly for 2 weeks by a licensed physiotherapist.

Abdominopelvic Fascial Release + Stretching ExercisesStretching Exercises Alone

Eligibility Criteria

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

You may qualify if:

  • Females aged 20 to 35 years.
  • History of at least one cesarean section.
  • Moderate to severe primary or secondary dysmenorrhea following cesarean section.
  • Regular menstrual cycles (21-35 days).
  • Body mass index (BMI) between 18.5 and 29.9 kg/m².
  • At least 6 months post-cesarean section to allow complete scar healing.
  • Presence of restricted cesarean scar mobility on clinical examination.
  • Willingness to participate and provide written informed consent.

You may not qualify if:

  • Pregnancy or planned pregnancy during the study period.
  • Previous abdominal or pelvic surgery other than cesarean section.
  • Endometriosis, adenomyosis, uterine fibroids requiring treatment, or other diagnosed gynecological disorders associated with pelvic pain.
  • Active pelvic inflammatory disease or genitourinary infection.
  • Neurological or musculoskeletal disorders affecting pain perception or mobility.
  • Systemic inflammatory, autoimmune, or connective tissue diseases.
  • Current participation in another physical therapy or manual therapy program targeting the abdomen or pelvis.
  • Use of corticosteroid injections or other invasive treatments to the abdominal or pelvic region within the previous 3 months.
  • Contraindications to manual therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Amira I. Hassanein

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by an independent assessor who will be blinded to treatment allocation. Participants will be instructed not to disclose their assigned intervention to the assessor. Due to the nature of the interventions, participants and treating therapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The control group will receive a standardized stretching exercise program, whereas the experimental group will receive myofascial release in addition to the same stretching exercise program. Outcomes will be compared between the two groups following completion of the intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Women's Health

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 21, 2026

Study Start

July 18, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07