Effects of Pelvic Floor Exercises and Pelvic Support Belt in Symphysis Pubis Dysfunction

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

Overview

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

Interventions

• Other 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
• Other 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

Primary outcome measures

• Visual Analog Scale (VAS): [Time frame: 6th week]
• Oswestry Disability Index (ODI) [Time frame: 6th week]
• Pelvic Floor Impact Questionnaire (PFIQ-7): [Time frame: 6th week]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Sadaf Yahya Hospital — Daska Kalan

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. PMID 37422748
• 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. PMID 35176817

Identifiers

NCT: NCT07440862 · REC/RCR&AHS/24/0539

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗