Clinical trial NCT06658210: Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pelvic Adhesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Adhesions
Post Hysterectomy Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 56
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric pain rating scale
timeFrame: 6 weeks
measure: Female sexual function index
timeFrame: 6 weeks
measure: Functional status questionnaire
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hanif Medical centre and Polyclinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hunaida Iftikhar Hunaida Iftikhar, MSPT*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.