NCT07715422

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Round ligament - pain- pregnancy- myofascial release- exercise

Outcome Measures

Primary Outcomes (1)

  • Pelvic Inclination Angle

    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.

    4 months

Study Arms (2)

No Intervention: Placebo Group routine belly band as well as advice

NO INTERVENTION

Intervention group participants joined a six-week physiotherapy plan of care in the form of session

EXPERIMENTAL
Other: Manual therapy technique named myofascial release combined with therapeutic exercises

Interventions

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.

Intervention group participants joined a six-week physiotherapy plan of care in the form of session

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double (participants and care provider)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A 6 months comparative randomized clinical trial comparing 2 groups of 70 women diagnosed with round ligament pain during pregnancy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of physical therapy for woman's health- Faculty of physical therapy - Beni-Suef University- Beni-Suef-Egypt

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start

December 10, 2025

Primary Completion

May 10, 2026

Study Completion

May 15, 2026

Last Updated

July 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations