- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07717983
Abdominopelvic Fascial Release for Post-Cesarean Menstrual Pain and Scar Mobility
Abdominopelvic Fascial Release for Post-Cesarean Menstrual Pain and Scar Mobility: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Cesarean section is one of the most commonly performed obstetric surgical procedures worldwide. Although it is frequently necessary to improve maternal and neonatal outcomes, postoperative healing may result in scar formation and fascial adhesions that can contribute to persistent menstrual pain, chronic pelvic pain, reduced scar mobility, abdominal tenderness, and impaired physical function. Fascial restrictions may alter tissue mobility and biomechanics, leading to pain and functional limitations.
Abdominopelvic fascial release is a manual therapy technique that applies sustained, low-load pressure to restricted fascial tissues to restore tissue mobility, improve fascial gliding, reduce pain, and enhance tissue function. Previous studies have demonstrated beneficial effects of fascial release on postoperative scar mobility, pain, and functional recovery; however, evidence regarding its effectiveness in women with menstrual pain following cesarean section remains limited.
The purpose of this prospective, randomized controlled trial is to evaluate whether the addition of abdominopelvic fascial release to a standardized stretching exercise program provides greater clinical benefit than a stretching exercise program alone in women with post-cesarean dysmenorrhea. Participants will be randomly assigned to one of two parallel groups and evaluated before and after completion of the intervention period using predefined clinical outcome measures.
The findings of this study are expected to provide evidence regarding the effectiveness of abdominopelvic fascial release as a non-pharmacological physical therapy intervention for reducing menstrual pain and improving scar mobility following cesarean section. The results may support the integration of fascial release techniques into postpartum rehabilitation programs and contribute to evidence-based physical therapy management for women with post-cesarean pain and scar-related dysfunction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amira I. Hassanein
- Email: ahassanein@horus.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
Experimental: Experimental Group
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.
|
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.
|
|
Active Comparator: Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menstrual Pain Intensity
Time Frame: Baseline and immediately after completion of the 4-week intervention period.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cesarean Scar Mobility
Time Frame: Baseline and immediately after completion of the 4-week intervention period.
|
Scar mobility will be assessed using an adheremeter.
Greater mobility values indicate improved scar tissue mobility.
|
Baseline and immediately after completion of the 4-week intervention period.
|
|
Change in Dysmenorrhea Severity
Time Frame: Baseline and immediately after completion of the 4-week intervention period.
|
Dysmenorrhea severity will be assessed using the WaLIDD Score.
|
Baseline and immediately after completion of the 4-week intervention period.
|
|
Change in Pressure Pain Threshold
Time Frame: Baseline and immediately after completion of the 4-week intervention period.
|
Pressure pain threshold will be assessed using a pressure algometer over the abdominal region.
|
Baseline and immediately after completion of the 4-week intervention period.
|
Collaborators and Investigators
Sponsor
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/012/006452
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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