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

NCT05865210 | Completed

• 1 other identifier: REC/RCR & AHS/23/0525
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Kegel Exercise with Myofascial release technique group:

EXPERIMENTAL

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

Other: Kegel Exercise; Other: Myofascial release technique

Kegel Exercise group

ACTIVE COMPARATOR

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

Other: Kegel Exercise

Interventions

Kegel Exercise OTHER

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.

Kegel Exercise group; Kegel Exercise with Myofascial release technique group:

Myofascial release technique OTHER

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.

Kegel Exercise with Myofascial release technique group:

Eligibility Criteria

• Age: 25 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

District Headquarters Hospital

Layyah, Punjab Province, 54700, Pakistan

Location

Related Publications (8)

• 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/

  PMID: 22439157 BACKGROUND

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

  PMID: 24658485 BACKGROUND

• 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.

  PMID: 19411059 BACKGROUND

• 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.

  PMID: 8826503 BACKGROUND

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

  PMID: 16290886 BACKGROUND

• 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.

  PMID: 18249016 BACKGROUND

• 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.

  PMID: 12744420 BACKGROUND

• 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.

  PMID: 15338362 BACKGROUND

MeSH Terms

Interventions

Myofascial Release Therapy

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tooba Zahid, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 18, 2023
• Study Start: April 15, 2023
• Primary Completion: September 5, 2023
• Study Completion: September 15, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)