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

Combined Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pain, Sexual Life Quality and Functional Mobility in Women With Post-operative Adhesions After Hysterectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Adhesions; Post Hysterectomy Pain
• Intervention / Treatment: Other: soft tissue mobilization with pelvic floor muscle exercises; Other: soft tissue mobilization without pelvic floor muscle exercises

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeela Arif Adeela Arif, Mphil; Phone Number: 923320845723; Email: adeela.arif@riphah.edu.pk
• Study Contact Backup: Name: Adeela Arif, Mphil; Phone Number: 923320845723; Email: adeela.arif@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Hanif Medical centre and Polyclinic
      • Contact: Hunaida Iftikhar, MSPT*; Phone Number: 923044147363; Email: hunaidairfan98@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: soft tissue mobilization with pelvic floor muscle exercises	Other: soft tissue mobilization with pelvic floor muscle exercises; Group A will receive soft tissue mobilization and pelvic floor muscle exercises. Soft tissue mobilization technique will include abdominal myofascial release/trigger point release and deep scar mobilization to decrease pain and improve scar mobility
Experimental: soft tissue mobilization without pelvic floor muscle exercises	Other: soft tissue mobilization without pelvic floor muscle exercises; Group B will receive soft tissue mobilization technique without pelvic floor exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain rating scale	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.	6 weeks
Female sexual function index	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)	6 weeks
Functional status questionnaire	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.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Hunaida Iftikhar Hunaida Iftikhar, MSPT*, Riphah International University

Publications and helpful links

General Publications

• Lang J, Ma D, Xiang Y, Hua K, Liu K, Pan L, Wang P, Yao S, Zhao F, Cheng W, Cui M, Guo H, Guo R, Hong L, Li P, Liu M, Meng Y, Wang H, Wang J, Wang W, Wu M, Yang X, Zhang J. Chinese expert consensus on the prevention of abdominal pelvic adhesions after gynecological tumor surgeries. Ann Transl Med. 2020 Feb;8(4):79. doi: 10.21037/atm.2020.02.53.
• Hu Q, Xia X, Kang X, Song P, Liu Z, Wang M, Lu X, Guan W, Liu S. A review of physiological and cellular mechanisms underlying fibrotic postoperative adhesion. Int J Biol Sci. 2021 Jan 1;17(1):298-306. doi: 10.7150/ijbs.54403. eCollection 2021.
• Li YT, Liu CH, Wang PH. Pelvic adhesion: A challenge of all gynecologic surgeries. J Chin Med Assoc. 2022 Aug 1;85(8):813-814. doi: 10.1097/JCMA.0000000000000756. Epub 2022 Aug 19. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cicatrix; Fibrosis; Tissue Adhesions
• Other Study ID Numbers: Hunaida Iftikhar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No