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

NCT06658210 | Recruiting

• 1 other identifier: Hunaida Iftikhar
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Adhesions; Post Hysterectomy Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

soft tissue mobilization with pelvic floor muscle exercises

EXPERIMENTAL

soft tissue mobilization with pelvic floor muscle exercises

Other: soft tissue mobilization with pelvic floor muscle exercises

soft tissue mobilization without pelvic floor muscle exercises

EXPERIMENTAL

soft tissue mobilization without pelvic floor muscle exercises

Other: soft tissue mobilization without pelvic floor muscle exercises

Interventions

soft tissue mobilization with pelvic floor muscle exercises OTHER

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

soft tissue mobilization with pelvic floor muscle exercises

soft tissue mobilization without pelvic floor muscle exercises OTHER

Group B will receive soft tissue mobilization technique without pelvic floor exercises.

soft tissue mobilization without pelvic floor muscle exercises

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hanif Medical centre and Polyclinic

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 32175372 BACKGROUND

• 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.

  PMID: 33390851 BACKGROUND

• 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.

  PMID: 35648144 BACKGROUND

Study Officials

• Hunaida Iftikhar Hunaida Iftikhar, MSPT*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeela Arif Adeela Arif, Mphil

CONTACT

923320845723; adeela.arif@riphah.edu.pk

Adeela Arif, Mphil

CONTACT

923320845723; adeela.arif@riphah.edu.pk

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: October 24, 2024
• First Posted: October 26, 2024
• Study Start: February 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)