Chronic Pelvic Pain SyndromeNCT05865210
Effects of Kegel Exercises With and Without Myofascial Release in Chronic Pelvic Pain
A study testing Kegel Exercise and Myofascial release technique in people with Chronic Pelvic Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome
- What is being tested?
- Kegel Exercise and Myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2023to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kegel Exercises With and Without Myofascial Release on Pain, Function and Quality of Life in Chronic Pelvic Pain
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
Read the 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.
- Conditions
- Chronic Pelvic Pain Syndrome
- Being tested
- Kegel Exercise, Myofascial release technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kegel ExerciseOther
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 techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Kegel Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 Apr 2023
- Primary completion5 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tooba Zahid, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865210
- Sponsor's protocol ID
- REC/RCR & AHS/23/0525
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/
PubMed 22439157Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.
PubMed 24658485Fillingim 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.
PubMed 19411059Unruh AM. Gender variations in clinical pain experience. Pain. 1996 May-Jun;65(2-3):123-67. doi: 10.1016/0304-3959(95)00214-6.
PubMed 8826503Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. doi: 10.1016/s1550-8579(05)80042-7.
PubMed 16290886Giamberardino 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.
PubMed 18249016Harlow 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.
PubMed 12744420Wu 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.
PubMed 15338362
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kegel Exercises With and Without Myofascial Release on Pain, Function and Quality of Life in Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05865210
- Acronym / sponsor ID
- REC/RCR & AHS/23/0525
- Conditions
- Chronic Pelvic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kegel Exercise with Myofascial release technique group: | Experimental | Other: Kegel Exercise, Other: Myofascial release techniqueGroup 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 |
| Kegel Exercise group | Active comparator | Other: Kegel ExerciseGroup 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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Age 25-55
Key exclusion criteria (6 listed)
- Acute active infection
- Malignancy
- Active pregnancy
- Pudendal nerve entrapment syndrome.
- Not simultaneously partaking in pelvic floor physical therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kegel ExerciseKegel 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. | Other | Kegel Exercise group, Kegel Exercise with Myofascial release technique group: |
| Myofascial release techniqueMyofasical 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. | Other | Kegel Exercise with Myofascial release technique group: |
Primary outcome
Numeric Pain Rating Scale
Time frame: 3 weeks
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):
Time frame: 3 weeks
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:
Time frame: 3 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 22439157Andrews 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/
- Background: PubMed 24658485Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.
- Background: PubMed 19411059Fillingim 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.
- Background: PubMed 8826503Unruh AM. Gender variations in clinical pain experience. Pain. 1996 May-Jun;65(2-3):123-67. doi: 10.1016/0304-3959(95)00214-6.
- Background: PubMed 16290886Wiesenfeld-Hallin Z. Sex differences in pain perception. Gend Med. 2005 Sep;2(3):137-45. doi: 10.1016/s1550-8579(05)80042-7.
- Background: PubMed 18249016Giamberardino 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.
- Background: PubMed 12744420Harlow 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.
- Background: PubMed 15338362Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tooba Zahid, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kegel Exercise and Myofascial release technique in people with Chronic Pelvic Pain Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865210, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.