- ICH GCP
- Registr klinických studií v USA
- Klinická 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Amira I. Hassanein
- E-mail: ahassanein@horus.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Aktivní komparátor: 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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Menstrual Pain Intensity
Časové okno: Baseline and immediately after completion of the 4-week intervention period.
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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.
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Baseline and immediately after completion of the 4-week intervention period.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Cesarean Scar Mobility
Časové okno: Baseline and immediately after completion of the 4-week intervention period.
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Scar mobility will be assessed using an adheremeter.
Greater mobility values indicate improved scar tissue mobility.
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Baseline and immediately after completion of the 4-week intervention period.
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Change in Dysmenorrhea Severity
Časové okno: Baseline and immediately after completion of the 4-week intervention period.
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Dysmenorrhea severity will be assessed using the WaLIDD Score.
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Baseline and immediately after completion of the 4-week intervention period.
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Change in Pressure Pain Threshold
Časové okno: Baseline and immediately after completion of the 4-week intervention period.
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Pressure pain threshold will be assessed using a pressure algometer over the abdominal region.
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Baseline and immediately after completion of the 4-week intervention period.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P.T.REC/012/006452
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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