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

Primary Purpose

Chronic Pelvic Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kegel Exercise
Myofascial release technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain Syndrome

Eligibility Criteria

25 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • District Headquarters HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kegel Exercise with Myofascial release technique group:

Kegel Exercise group

Arm Description

Group A, we told patient to perform kegel exercise by hold and relax the pelvic floor muscles, initially 3-4 contractions for 3-5 seconds then we increase the repetition according to patient and apply myofascial release for trigger points. 4 session per week and post intervention assessment after 3 weeks follow-up

Group B, In this group we only perform kegel exercises to patients as hold and relax of pelvic floor muscle 3-4 contraction for 3-5 seconds.4 session per week and post intervention assessment after 3 weeks follow-up

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 9, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05865210
Brief Title
Effects of Kegel Exercises With and Without Myofascial Release in Chronic Pelvic Pain
Official Title
Effects of Kegel Exercises With and Without Myofascial Release on Pain, Function and Quality of Life in Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
September 5, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kegel Exercise with Myofascial release technique group:
Arm Type
Experimental
Arm Description
Group A, we told patient to perform kegel exercise by hold and relax the pelvic floor muscles, initially 3-4 contractions for 3-5 seconds then we increase the repetition according to patient and apply myofascial release for trigger points. 4 session per week and post intervention assessment after 3 weeks follow-up
Arm Title
Kegel Exercise group
Arm Type
Active Comparator
Arm Description
Group B, In this group we only perform kegel exercises to patients as hold and relax of pelvic floor muscle 3-4 contraction for 3-5 seconds.4 session per week and post intervention assessment after 3 weeks follow-up
Intervention Type
Other
Intervention Name(s)
Kegel Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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
Time Frame
3 weeks
Title
Pelvic floor Impact Questionnaire (PFIQ):
Description
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
Time Frame
3 weeks
Title
Functional pelvic pain scale:
Description
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
Time Frame
3 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tooba Zahid, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Headquarters Hospital
City
Layyah
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22439157
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/
Results Reference
background
PubMed Identifier
24658485
Citation
Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.
Results Reference
background
PubMed Identifier
19411059
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.
Results Reference
background
PubMed Identifier
8826503
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.
Results Reference
background
PubMed Identifier
16290886
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.
Results Reference
background
PubMed Identifier
18249016
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.
Results Reference
background
PubMed Identifier
12744420
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.
Results Reference
background
PubMed Identifier
15338362
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.
Results Reference
background

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

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