- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Amira I. Hassanein
- E-Mail: ahassanein@horus.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Menstrual Pain Intensity
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Cesarean Scar Mobility
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P.T.REC/012/006452
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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