- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440862
Effects of Pelvic Floor Exercises and Pelvic Support Belt in Symphysis Pubis Dysfunction
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
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Daska Kalan, Pakistan
- Recruiting
- Sadaf Yahya Hospital
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Contact:
- mehar un nisa shafique, MS
- Phone Number: 03344563221
- Email: meharun.nisa@riphah.edu.pk
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Principal Investigator:
- wajeeha siddiqui, MSPT-WH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pelvic floor excercises
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.
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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
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
|
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Experimental: pelvic support belt
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
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale (VAS):
Time Frame: 6th week
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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
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6th week
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Oswestry Disability Index (ODI)
Time Frame: 6th week
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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
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6th week
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Pelvic Floor Impact Questionnaire (PFIQ-7):
Time Frame: 6th week
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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
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6th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mehar un nisa shafique, MS, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- ALIAA 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Diastasis, Bone
- Urogenital Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Wounds and Injuries
- Female Urogenital Diseases and Pregnancy Complications
- Joint Diseases
- Pregnancy Complications
- Musculoskeletal Pain
- Pelvic Pain
- Puerperal Disorders
- Joint Dislocations
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pain
- Pelvic Girdle Pain
- Motor Activity
- Pubic Symphysis Diastasis
Other Study ID Numbers
- REC/RCR&AHS/24/0539
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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