- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07715422
Effect of Direct Myofascial Release Technique Combined With Exercise on Round Ligament Pain During Pregnancy
Effect of Direct Myofascial Release Technique Combined With Exercise on Round Ligament Pain During Pregnancy: A Randomized Clinical Trial
Study's objective is to explore effect of combining direct myofascial release technique with therapeutic exercises on decreasing round ligament pain during pregnancy.The main question to be answered by this study:
Does a myofascial release technique combined with exercise have effect on round ligament pain during pregnancy? Researchers will compare 2 groups of 70 participants of multi para pregnant women at 24 weeks' of gestation diagnosed with round ligament pain . Group A (study group) included participants who joined a six-week physiotherapy plan of care in the form of sessions composed of direct myofascial release technique combined with specific therapeutic exercise as well as put on a belly band and received advice.
While, group B involved control participants who followed the routine care and advice as well as wearing the same belly band as group A participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Egypten
- Beni-Suef University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 70 multipara pregnant women at 24 weeks' of gestation diagnosed with round ligament pain were included. Their ages ranged from 25-35 years and their body mass index (BMI) did not exceed 30 kg/m2.
Exclusion Criteria:
- Participants were excluded from the study if round ligament pain was accompanied by cramping, vaginal bleeding, fever, nausea, vomiting, or any changes in vaginal discharge as well as patients diagnosed with preterm labor, placental abruption, urinary tract infections, appendicitis, cardiac diseases, chronic physical or mental disorders, or failed to complete an informed consent.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: No Intervention: Placebo Group routine belly band as well as advice
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Eksperimentel: Intervention group participants joined a six-week physiotherapy plan of care in the form of session
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Round ligament release technique was conducted first from left side lying position followed by right side lying position with a pillow between knees and another pillow supported head, determining round ligament as a fibromuscular cordlike structure in lower abdomen particularly at the area of the Inguinal Canal between Anterior Superior Iliac Spine and 2-3 cm laterally from Symphysis Pubis.12
Then, therapist applied very gentle sustained pressure with minor traction to restricted part of round ligament for 90 to 120 seconds according to patient's tolerance followed by release for 3 minutes.As well as, group of therapeutic exercises.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pelvic Inclination Angle
Tidsramme: 4 months
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Pelvic inclination or pelvic tilting angle was measured in sagittal plane between a horizontal line and a line bifurcating the Anterior Superior Iliac Spine and Posterior Superior Iliac Spine for all participants by using Palpation Meter Inclinometer at the start and the end of the study.
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4 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FMBSUREC/02122025/Awad
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Graviditetskomplikationer
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Kahramanmaras Sutcu Imam UniversityAfsluttetFedme, sygelig | Perioperativ komplikation | BMD | Laparaskopisk ærmegatrektomi | Fedmekirurgi Dødelighedsscore | Clavien Dindo Surgical Complication Scale
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Ondokuz Mayıs UniversityIkke rekrutterer endnuObstruktion af blæreudløb | Nedre urinvejssymptomer (LUTS) | Benign prostataforstørrelse (BPE) | Clavien Dindo Surgical Complication Scale | Urininkontinens efter kirurgisk indgreb | Trifecta -præstation | HolepTyrkiet (Türkiye)
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige