- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beni Suweif Governorate
-
Banī Suwayf, Beni Suweif Governorate, Egypt
- Beni-Suef University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention: Placebo Group routine belly band as well as advice
|
|
|
Experimental: Intervention group participants joined a six-week physiotherapy plan of care in the form of session
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic Inclination Angle
Time Frame: 4 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- FMBSUREC/02122025/Awad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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