Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pelvic Adhesions

Not Applicable

Recruiting

• Conditions: Pelvic Adhesions; Post Hysterectomy Pain

• Registration Number: NCT06658210
• Lead Sponsor: Riphah International University

Brief Summary

Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. Adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. These triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. This may cause adjacent structures to lose their flexibility and mobility. The nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.

Detailed Description

This study will be randomized controlled trial and will be conducted in Hanif medical center and poly clinic and Lady willingdon hospital. The total duration of treatment will be 10 week.

Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and Group B will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. The tools that will be used are Numeric Pain Rating Scale (NPRS), Female Sexual Function Index (FSFI) and Functional status questionnaire (FSQ). After data collection data will be analyzed by using SPSS version 25.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• Married women
• Age 40-60 years
• BMI below 30 (13)
• Women with post-operative pelvic adhesions (14)
• Women after hysterectomy (3 months after surgery)

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Exclusion Criteria

• Women with any other surgery
• Women with failed pelvic surgery (14)
• Post-operative women with open wound (unhealed suture site) (14)
• Women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric pain rating scale	6 weeks	The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Female sexual function index	6 weeks	The FSFI questionnaire consists of 19 close-ended questions related to sexual activity and includes six domains: * Sexual desire (question number 1-2); * Sexual arousal (question number 3-6); * Lubrication (question number 7-10); * Orgasm (question number 11-13); * Sexual satisfaction (question number 14-19)
Functional status questionnaire	6 weeks	The Functional Status Questionnaire (FSQ) is a brief, self-administered questionnaire developed by researchers from Boston's Beth Israel Hospital and the University of California at Los Angeles. The FSQ was designed to screen for disability and to monitor clinically meaningful change in function.

Trial Locations

Locations (1)

Hanif Medical centre and Polyclinic; 🇵🇰 Lahore, Punjab, Pakistan