Pregnancy ComplicationsNCT07715422
Effect of Direct Myofascial Release Technique Combined With Exercise on Round Ligament Pain During Pregnancy
A study testing Manual therapy technique named myofascial release combined with therapeutic exercises in people with Pregnancy Complications, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Manual therapy technique named myofascial release combined with therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2025to 13 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy Complications
- Being tested
- Manual therapy technique named myofascial release combined with therapeutic exercises
- Keywords
- Round ligament - pain- pregnancy- myofascial release- exercise
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy technique named myofascial release combined with therapeutic exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Placebo Group routine belly band as well as advice | No intervention | Not described |
| Intervention group participants joined a six-week physiotherapy plan of care in the form of session | Experimental | Not described Receives: Other: Manual therapy technique named myofascial release combined with therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start10 Dec 2025
- Primary completion2 Oct 2026
- Study completion13 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 6 months comparative randomized clinical trial comparing 2 groups of 70 women diagnosed with round ligament pain during pregnancy.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Awad, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715422
- Sponsor's protocol ID
- FMBSUREC/02122025/Awad
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Direct Myofascial Release Technique Combined With Exercise on Round Ligament Pain During Pregnancy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07715422
- Acronym / sponsor ID
- FMBSUREC/02122025/Awad
- Conditions
- Pregnancy Complications
- Keywords
- Round ligament - pain- pregnancy- myofascial release- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 13 Oct 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A 6 months comparative randomized clinical trial comparing 2 groups of 70 women diagnosed with round ligament pain during pregnancy.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy technique named myofascial release combined with therapeutic exercisesRound 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. | Other | Intervention group participants joined a six-week physiotherapy plan of care in the form of session |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy technique named myofascial release combined with therapeutic exercises in people with Pregnancy Complications, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Inclination Angle (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.