Pubic Symphysis DiastasisNCT07440862
Effects of Pelvic Floor Exercises and Pelvic Support Belt in Symphysis Pubis Dysfunction
A study testing pelvic floor excercises and pelvic support belt in people with Pubic Symphysis Diastasis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Symphysis Pubis Dysfunction (SPD) is a medical condition that affects the pelvic region, particularly the joint that joins the two pubic bones at the front of the pelvis, the pubic symphysis. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pubic Symphysis Diastasis
- What is being tested?
- pelvic floor excercises and pelvic support belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multigravida females
- Women diagnosed with pubic symphysis dysfunction
- Females willing to provide informed consent to participate in the study.
- Functional Status: Able to engage in physical activity without significant contraindications.
- Symptom Severity: Experience pain and disability due to symphysis pubis dysfunction
- Previous Treatment: May not have undergone pelvic floor therapy.
Who cannot join
- • Participants below 8 years and above 12 years.
- Any Psychological issue
- Primigravida Females
- Significant neurological disorders, pelvic pain syndromes, or conditions affecting pelvic floor function.
- Pelvic Floor Disorders: Presence of other pelvic floor disorders (e.g., Fecal Incontinence, Urinary Incontinence)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sadaf Yahya Hospital
Daska Kalan
mehar un nisa shafique, MS, 03344563221, meharun.nisa@riphah.edu.pk
wajeeha siddiqui, MSPT-WH
About this study
Official title: Effects of Pelvic Floor Exercises With and Without Pelvic Support Belt on Pain, Functions and Disability Among Post-partum Females With Symphysis Pubis Dysfunction
Symphysis Pubis Dysfunction (SPD) is a medical condition that affects the pelvic region, particularly the joint that joins the two pubic bones at the front of the pelvis, the pubic symphysis. Although normally this joint is quite stable, the ligaments surrounding the pelvis loosen in preparation for childbirth due to hormonal changes during pregnancy, particularly an increase in a hormone called relaxin. This may result in pelvic joint instability, which can cause pain and discomfort, usually in the pelvic region, lower abdomen, or groin. Symptoms, physical examination, and medical history are frequently used to diagnose SPD. Medical professionals may also test for pelvic instability and assess for tenderness near the pubic symphysis. Imaging (such as an X-ray or ultrasound) may be performed to rule out other disorders in certain situations, but it is not always required.
The study will be a randomized clinical trial and will be conducted in Fatima Medical Complex, Hameeda Bashir Hospital, Sadaf Yahya Hospital and Tehsil Head Quarter (THQ) Daska. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and 48 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive Phonophoresis for 10 minutes as baseline treatment and pelvic floor exercises (Kegel Exercises, Bridging, Pelvic Tilt, Squats, Dead Bug) with pelvic support belt whereas Group B will receive only pelvic floor exercises and Phonophoresis as baseline treatment. The tools that will be used are Oswestry Disability Index, Pelvic Floor Impact Questionnaire (PFIQ-7) and Visual Analog Scale (VAS) for assessing Pain, Disability and functioning. After data collection, data will be analyzed by using SPSS version 25.
Keywords: pelvic floor, exercises, post-partum, symphysis pubis dysfunction, pain, function, disability
- Conditions
- Pubic Symphysis Diastasis
- Being tested
- pelvic floor excercises, pelvic support belt
- Keywords
- pelvic floor, exercises, post-partum, symphysis pubis dysfunction, pain, function, disability
- Medical subject headings
- Pubic Symphysis Diastasis, Motor Activity, Pelvic Girdle Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor excercisesOther
Group A patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximun including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week with pelvic support belt
pelvic support beltOther
Group B patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximum including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week without pelvic support belt
| Study group | Role | What they receive |
|---|---|---|
| pelvic floor excercises | Experimental | Group A patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximun including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week with pelvic support belt. Receives: Other: pelvic floor excercises; Other: pelvic support belt |
| pelvic support belt | Experimental | Group B patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximum including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week without pelvic support belt Receives: Other: pelvic support belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS):
Visual Analogue Scale (VAS) is frequently used to gauge the severity of pain in a variety of healthcare settings across the globe. For determining how much pain a patient is suffering, it is an easy, rapid, and efficient tool.(13) VAS exhibits great repeatability and test-retest reliability.(14) VAS features a continuous scale made up of both horizontal and vertical lines, which are referred to as the vertical VAS and horizontal visual analogue scale. The vertical and horizontal VAS have a strong association. However, the horizontal VAS score is slightly lower than the vertical VAS score
Measured: 6th week
Oswestry Disability Index (ODI)
The original Oswestry Disability Index (ODI) was developed in a specialist referral clinic for patients with chronic low back pain. (17) The Oswestry (version 2.1a) 21 is a 10-item, self report questionnaire that consists of items regarding the physical effects of pain and asks participants to rate their pain level (Section 1) and their ability to perform 9 tasks (Sections 2 through 10). Responses are graded on 6-point scales (0-5) for each item, with higher scores indicative of higher levels of perceived disability. The ODI refers to the ratio of the total score to the maximum score and is expressed as a percentage
Measured: 6th week
Pelvic Floor Impact Questionnaire (PFIQ-7):
PFIQ covers the impact of POP on daily life.(19) The PFIQ consists of 21 items that measures the impact of bladder, bowel, and vaginal symptoms on daily activity, social/relationships, and emotional health. Response options range from 0 ("not at all") to 3PFIQ covers the impact of POP on daily life.(19) The PFIQ consists of 21 items that measures the impact of bladder, bowel, and vaginal symptoms on daily activity, social/relationships, and emotional health. Response options range from 0 ("not at all") to 3 ("quite a bit"). In each scale, the mean score of answered items is multiplied by 33.3 to obtain the scale score (range 0-100). Summary scores are calculated by adding up the scale scores (range 0-300). Higher scores indicate more impact on daily activity
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jun 2025
- Primary completionMar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pubic Symphysis DiastasisStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mehar un nisa shafique, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440862
- Sponsor's protocol ID
- REC/RCR&AHS/24/0539
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patil VR, Sharma RK, editors. POST PREGNANCY-SYMPHYSIS PUBIS DYSFUNCTION AND PAIN MANAGEMENT USING MODIFIED PELVIC BELTS: A REVIEW. Obstetrics and Gynaecology Forum; 2024.
Borscheva A, Pertseva G, Alekseeva N. Dysfunction of the symphysis as one of the actual problems of modern obstetrics. Medical Herald of the South of Russia. 2021;12(3):44-9.
Mamipour H, Farazmehr S, Negahban H, Nazary-Moghadam S, Dehghan-Manshadi F, Navi Nezhad M, Jafari S, Sharifzadeh M. Effect of Core Stabilization Exercises on Pain, Functional Disability, and Quality of Life in Pregnant Women With Lumbar and Pelvic Girdle Pain: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2023 Jan;46(1):27-36. doi: 10.1016/j.jmpt.2023.05.005. Epub 2023 Jul 7.
PubMed 37422748ALIAA EH, MAGDA SM, MOHAMED FA. Effect of Phonophoresis and Pelvic Brace on Symphysis Pubis Pain after Delivery. The Medical Journal of Cairo University. 2024;92(03):31-7.
Morimoto K, Harrington A, Nelson C, Loveless B. Osteopathic approach to sacroiliac joint pain in pregnant patients. J Osteopath Med. 2022 Feb 18;122(5):235-242. doi: 10.1515/jom-2021-0231.
PubMed 35176817
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Exercises With and Without Pelvic Support Belt on Pain, Functions and Disability Among Post-partum Females With Symphysis Pubis Dysfunction
- ClinicalTrials.gov ID
- NCT07440862
- Acronym / sponsor ID
- REC/RCR&AHS/24/0539
- Conditions
- Pubic Symphysis Diastasis
- Keywords
- pelvic floor, exercises, post-partum, symphysis pubis dysfunction, pain, function, disability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Feb 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.
Symphysis Pubis Dysfunction (SPD) is a medical condition that affects the pelvic region, particularly the joint that joins the two pubic bones at the front of the pelvis, the pubic symphysis. Although normally this joint is quite stable, the ligaments surrounding the pelvis loosen in preparation for childbirth due to hormonal changes during pregnancy, particularly an increase in a hormone called relaxin. This may result in pelvic joint instability, which can cause pain and discomfort, usually in the pelvic region, lower abdomen, or groin. Symptoms, physical examination, and medical history are frequently used to diagnose SPD. Medical professionals may also test for pelvic instability and assess for tenderness near the pubic symphysis. Imaging (such as an X-ray or ultrasound) may be performed to rule out other disorders in certain situations, but it is not always required.
The study will be a randomized clinical trial and will be conducted in Fatima Medical Complex, Hameeda Bashir Hospital, Sadaf Yahya Hospital and Tehsil Head Quarter (THQ) Daska. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and 48 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive Phonophoresis for 10 minutes as baseline treatment and pelvic floor exercises (Kegel Exercises, Bridging, Pelvic Tilt, Squats, Dead Bug) with pelvic support belt whereas Group B will receive only pelvic floor exercises and Phonophoresis as baseline treatment. The tools that will be used are Oswestry Disability Index, Pelvic Floor Impact Questionnaire (PFIQ-7) and Visual Analog Scale (VAS) for assessing Pain, Disability and functioning. After data collection, data will be analyzed by using SPSS version 25.
Keywords: pelvic floor, exercises, post-partum, symphysis pubis dysfunction, pain, function, disability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic floor excercises | Experimental | Other: pelvic floor excercises, Other: pelvic support beltGroup A patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximun including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week with pelvic support belt. |
| pelvic support belt | Experimental | Other: pelvic support beltGroup B patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximum including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week without pelvic support belt |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Multigravida females
- Women diagnosed with pubic symphysis dysfunction
- Females willing to provide informed consent to participate in the study.
- Functional Status: Able to engage in physical activity without significant contraindications.
- Symptom Severity: Experience pain and disability due to symphysis pubis dysfunction
Key exclusion criteria (5 listed)
- • Participants below 8 years and above 12 years.
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 |
|---|---|---|
| pelvic floor excercisesGroup A patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximun including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week with pelvic support belt | Other | pelvic floor excercises |
| pelvic support beltGroup B patients will be given 10 minutes session of Phonophoresis as baseline treatment and pelvic floor exercises with 10 repetitions maximum including Kegel Exercises, Dead Bug, Bridging, Pelvic tilt and Squats with 2 sets each for up to 3-5 times a week without pelvic support belt | Other | pelvic floor excercises, pelvic support belt |
Primary outcome
Visual Analog Scale (VAS):
Time frame: 6th week
Visual Analogue Scale (VAS) is frequently used to gauge the severity of pain in a variety of healthcare settings across the globe. For determining how much pain a patient is suffering, it is an easy, rapid, and efficient tool.(13) VAS exhibits great repeatability and test-retest reliability.(14) VAS features a continuous scale made up of both horizontal and vertical lines, which are referred to as the vertical VAS and horizontal visual analogue scale. The vertical and horizontal VAS have a strong association. However, the horizontal VAS score is slightly lower than the vertical VAS score
Oswestry Disability Index (ODI)
Time frame: 6th week
The original Oswestry Disability Index (ODI) was developed in a specialist referral clinic for patients with chronic low back pain. (17) The Oswestry (version 2.1a) 21 is a 10-item, self report questionnaire that consists of items regarding the physical effects of pain and asks participants to rate their pain level (Section 1) and their ability to perform 9 tasks (Sections 2 through 10). Responses are graded on 6-point scales (0-5) for each item, with higher scores indicative of higher levels of perceived disability. The ODI refers to the ratio of the total score to the maximum score and is expressed as a percentage
Pelvic Floor Impact Questionnaire (PFIQ-7):
Time frame: 6th week
PFIQ covers the impact of POP on daily life.(19) The PFIQ consists of 21 items that measures the impact of bladder, bowel, and vaginal symptoms on daily activity, social/relationships, and emotional health. Response options range from 0 ("not at all") to 3PFIQ covers the impact of POP on daily life.(19) The PFIQ consists of 21 items that measures the impact of bladder, bowel, and vaginal symptoms on daily activity, social/relationships, and emotional health. Response options range from 0 ("not at all") to 3 ("quite a bit"). In each scale, the mean score of answered items is multiplied by 33.3 to obtain the scale score (range 0-100). Summary scores are calculated by adding up the scale scores (range 0-300). Higher scores indicate more impact on daily activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- BackgroundPatil VR, Sharma RK, editors. POST PREGNANCY-SYMPHYSIS PUBIS DYSFUNCTION AND PAIN MANAGEMENT USING MODIFIED PELVIC BELTS: A REVIEW. Obstetrics and Gynaecology Forum; 2024.
- BackgroundBorscheva A, Pertseva G, Alekseeva N. Dysfunction of the symphysis as one of the actual problems of modern obstetrics. Medical Herald of the South of Russia. 2021;12(3):44-9.
- Background: PubMed 37422748Mamipour H, Farazmehr S, Negahban H, Nazary-Moghadam S, Dehghan-Manshadi F, Navi Nezhad M, Jafari S, Sharifzadeh M. Effect of Core Stabilization Exercises on Pain, Functional Disability, and Quality of Life in Pregnant Women With Lumbar and Pelvic Girdle Pain: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2023 Jan;46(1):27-36. doi: 10.1016/j.jmpt.2023.05.005. Epub 2023 Jul 7.
- BackgroundALIAA EH, MAGDA SM, MOHAMED FA. Effect of Phonophoresis and Pelvic Brace on Symphysis Pubis Pain after Delivery. The Medical Journal of Cairo University. 2024;92(03):31-7.
- Background: PubMed 35176817Morimoto K, Harrington A, Nelson C, Loveless B. Osteopathic approach to sacroiliac joint pain in pregnant patients. J Osteopath Med. 2022 Feb 18;122(5):235-242. doi: 10.1515/jom-2021-0231.
- Individual participant dataSharing planned: No
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.
mehar un nisa shafique, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor excercises and pelvic support belt in people with Pubic Symphysis Diastasis, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS): (time frame: 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07440862, which also lists 5 linked publications.
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 27 Feb 2026.