Effects of Kegel Exercises With and Without Myofascial Release in Chronic Pelvic Pain

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

Effects of Kegel Exercises With and Without Myofascial Release on Pain, Function and Quality of Life in Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865210
• Other study ID #: REC/RCR & AHS/23/0525
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study will be a Randomized control trial to check the effects of kegel exercise with and without myofascial release on chronic pelvic pain in females so that we can examine the effect of above techniques on pain, function and quality of life in chronic pelvic pain females.Non-probability convenience sampling technique will be used, subject following eligibility criteria from DHQ Hospital Layyah will be randomly allocated in two groups. Group A participants will be given kegel exercise with myofascial release, Group B participants will be given kegel exercise for 3 weeks. Assessment will be done via, Numeric Pain Rating Scale and pelvic floor impact questionnaire (PFIQ) and functional pelvic pain scale

Description:

Chronic pelvic pain (CPP), defined as a noncyclical pain lasting for more than 6 months can lead to lower physical performance and quality of life in women. In this study the effects of Kegel Exercise with and without myofascial release in chronic pelvic pain population will be analyzed. This study will be a randomized clinical trial. Kegel Exercise and Myofasical Release would be administered to the chronic Pelvic pain Females. Subjects meeting the predetermined inclusion criteria will be divided into two groups. Assessment will be done using Numeric Pain rating scale (NPR), Pelvic floor Impact Questionnaire (PFIQ) and Functional pelvic pain scale (FPPS). Subjects in one group will be treated with kegel exercise with myofascial release, and the other will be treated with kegel exercise only. Each subject will receive a total 12 treatment sessions, with 04 treatment sessions per week. Measurements will be recorded at start and end of treatment session. Recorded values will be analyzed for any change using SPSS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 15, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• • Age 25-55
• Record of CPPS for more than 6 months.
• Complete gynaecological consultation with necessary workup.
• Chronic pelvic pain associated with gynaecological issue.
• Patients who have tenderness upon palpation are included, suggesting that the trigger points are painful.
• Patient that can't cope with their daily activities

Exclusion Criteria:

• Acute active infection
• Malignancy
• Active pregnancy
• Pudendal nerve entrapment syndrome.
• Not simultaneously partaking in pelvic floor physical therapy.
• No evoked tenderness upon palpation of levator ani sling at examination.

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Pain

Intervention

Other:
• Kegel Exercise
Kegel exercises (also called pelvic floor exercises) will be used to strengthen the pelvic floor muscles it will involve repeatedly contracting and relaxing the muscles that form part of the pelvic floor.
• Myofascial release technique
Myofasical release will include deep pressure for 10-15 seconds to release the trigger points and also gentle, light soft tissue massage on the vaginal muscles and surrounding areas.

Locations

Country	Name	City	State
Pakistan	District Headquarters Hospital	Layyah	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7. — View Citation

Andrews J, Yunker A, Reynolds WS, Likis FE, Sathe NA, Jerome RN. Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jan. Report No.: 11(12)-EHC088-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK84586/ — View Citation

Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001. — View Citation

Giamberardino MA. Women and visceral pain: are the reproductive organs the main protagonists? Mini-review at the occasion of the "European Week Against Pain in Women 2007". Eur J Pain. 2008 Apr;12(3):257-60. doi: 10.1016/j.ejpain.2007.11.007. Epub 2008 Jan 14. No abstract available. — View Citation

Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8. — View Citation

Unruh AM. Gender variations in clinical pain experience. Pain. 1996 May-Jun;65(2-3):123-67. doi: 10.1016/0304-3959(95)00214-6. — View Citation

Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. doi: 10.1016/s1550-8579(05)80042-7. — View Citation

Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes. changes from Baseline to 3 week	3 weeks
Primary	Pelvic floor Impact Questionnaire (PFIQ):	The PFIQ-7 consists of 7 questions that need to be answered 3 times each (corresponds to the scales previously mentioned) considering symptoms related to the bladder or urine, vagina or pelvis, and bowel or rectum and their effect on function, social health, and mental health in the past 3 months. The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life. changes from Baseline to 3 week	3 weeks
Primary	Functional pelvic pain scale:	The FPPS is a sensitive and reliable measure of pelvic pain intensity through, time, demonstrating evidence of validity. Functional Pelvic Pain Scale (FPPS), designed to measure pelvic pain intensity as it relates to functions of daily living (bladder and bowel function, intercourse, walking, running, lifting, working, and sleeping). changes from Baseline to 3 week	3 weeks