Hanif Medical centre and Polyclinic
Lahore, Punjab Province, Pakistan
Location status: Recruiting
Recruiting
NCT Number: NCT06658210
Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pelvic Adhesions
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
40 year–60 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
soft tissue mobilization with pelvic floor muscle exercises
OtherGroup 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 without pelvic floor muscle exercises
OtherGroup B will receive soft tissue mobilization technique without pelvic floor exercises.
Primary outcomes
-
Numeric pain rating scale
Time frame: 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
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Adeela Arif Adeela Arif, Mphil
CONTACT
Adeela Arif, Mphil
CONTACT
Sponsors and collaborators
Lead sponsor
Riphah International University
Other
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Oct 26, 2024
- Registry last updated
- Oct 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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