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

NCT ID: NCT06658210

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-20

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.

Conditions

Pelvic Adhesions; Post Hysterectomy Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

soft tissue mobilization with pelvic floor muscle exercises

soft tissue mobilization with pelvic floor muscle exercises

Group Type: EXPERIMENTAL

soft tissue mobilization with pelvic floor muscle exercises

Intervention Type: 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 without pelvic floor muscle exercises

soft tissue mobilization without pelvic floor muscle exercises

Group Type: EXPERIMENTAL

soft tissue mobilization without pelvic floor muscle exercises

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

soft tissue mobilization without pelvic floor muscle exercises

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hunaida Iftikhar Hunaida Iftikhar, MSPT*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Hanif Medical centre and Polyclinic

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Adeela Arif Adeela Arif, Mphil

Role: CONTACT

adeela.arif@riphah.edu.pk

923320845723

Adeela Arif, Mphil

Role: CONTACT

adeela.arif@riphah.edu.pk

923320845723

Facility Contacts

Hunaida Iftikhar, MSPT*

Role: primary

hunaidairfan98@gmail.com

923044147363

References

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.

Reference Type: BACKGROUND

PMID: 32175372 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33390851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35648144 (View on PubMed)

Other Identifiers

Hunaida Iftikhar

Identifier Type: -

Identifier Source: org_study_id