NCT07440862

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 23, 2026

Last Update Submit

February 23, 2026

Conditions

Keywords

pelvic floorexercisespost-partumsymphysis pubis dysfunctionpainfunctiondisability

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    6th week

Study Arms (2)

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.

Other: pelvic floor excercisesOther: 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

Other: pelvic support belt

Interventions

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 floor excercises

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

pelvic floor excercisespelvic support belt

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost partum pubic symphysis dysfunction
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadaf Yahya Hospital

Daska Kalan, Pakistan

RECRUITING

Related Publications (5)

  • Patil VR, Sharma RK, editors. POST PREGNANCY-SYMPHYSIS PUBIS DYSFUNCTION AND PAIN MANAGEMENT USING MODIFIED PELVIC BELTS: A REVIEW. Obstetrics and Gynaecology Forum; 2024.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 37422748BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35176817BACKGROUND

MeSH Terms

Conditions

Pubic Symphysis DiastasisMotor ActivityPelvic Girdle PainPain

Condition Hierarchy (Ancestors)

Diastasis, BoneJoint DislocationsJoint DiseasesMusculoskeletal DiseasesPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesWounds and InjuriesBehaviorMusculoskeletal PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • mehar un nisa shafique, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

February 27, 2026

Study Start

June 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations