Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Genitio Pelvic Pain
March 4, 2024 updated by: Riphah International University
Effects of Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Women With Genito Pelvic Pain
Study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain.
Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method.
Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire.
Subjects in one group will be treated with soft tissue release and vaginal dilators.
And the other will be treated with soft tissue release only.
Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week.
Measurements will be recorded at baseline, 5th and 9th treatment session.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Painful sexual intercourse is a common female health problem.
It is a complex disorder that often goes neglected.
It can be further categorized into superficial or deep, and primary or secondary.
Superficial is limited to the vulva or vaginal entrance, while deep means the extension of pain into the deeper parts of the vagina or lower pelvis.
Deep dyspareunia is frequently associated with deep penetration.
Primary pain initiates at the start of sexual intercourse, while in secondary, pain begins after some time of pain free sexual activity This study will be a randomized clinical trial which will incorporate two different interventions soft tissue release and vaginal dilators use would be administered to the women with genito pelvic pain.
Subjects meeting the predetermined inclusion criteria will be divided into two groups using lottery method.
Assessment will be done using GPPPD, Vancouver Visual Analogue Scale, female sexual function index and pelvic floor impact questionnaire .
Subjects in one group will be treated with soft tissue release and vaginal dilators.
And the other will be treated with soft tissue release only.
Each subject will receive a total 09 treatment sessions, with 03 treatment sessions per week.
Measurements will be recorded at baseline, 5th and 9th treatment session.
Recorded values will be analyzed for any change using SPSS21.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Lahore General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Women age 20 to 40 years
- Patient fulfilling DSM5 GPPPD criteria
- Pain in genitals before during or after intercourse
- Pain greater than 4 on a 10cm visual analogue scale
Exclusion Criteria:
• History of pathological conditions like infections
- Endometriosis
- Tumors
- Major psychiatric disorders
- Painful bladder syndrome
- Surgery of pelvic organs
- Any ongoing treatment of genito pelvic pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: soft tissue release with vaginal dilators
Group A will receive soft tissue release with vaginal diltors.
Soft tissue release consists of myofacial release and deep intervaginal massage.Triggers points can be released vaginally or rectally they are so painfyul on palpation deep massage of pelvic floor muscle
|
Patient will be asked to lie in hook lying position using a clean glove will apply some water based lubricant gently sweep vaginal muscle from superficial to deep until find a trigger point press it and release it using circle motion for 1 to 2 minute until the trigger point is completely released.
Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones.
|
|
Active Comparator: soft tissue release only
will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage
|
Patient will be asked to lie in hook lying position using a clean glove will apply some water based lubricant gently sweep vaginal muscle from superficial to deep until find a trigger point press it and release it using circle motion for 1 to 2 minute until the trigger point is completely released.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Female sexual function index
Time Frame: up to 3 weeks
|
The Female Sexual Function Index (FSFI) is a very well-worded sexual function screen with excellent psychometric qualities.
However, some aspects of the scoring procedures pose conceptual and statistical problems, which we illustrate in part by way of an empirical example.
The recommended solutions should further strengthen the utility and validity of this instrument
|
up to 3 weeks
|
|
Visual analogue scale
Time Frame: up to 3 weeks
|
Describes the construction of visual analogue scale that could be used with critically ill patients, the structural and visual cues on this VAS allow for exact placement of the template and reliable measurements.
Rates pain from 1 to 10.
|
up to 3 weeks
|
|
Pelvic floor impact questionnaire
Time Frame: up to 3 weeks
|
The Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire-7 are valid, reliable, and responsive short forms of 2 condition-specific quality-of-life questionnaires for women with pelvic floor disorders
|
up to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asma Ambreen, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Ghaderi F, Bastani P, Hajebrahimi S, Jafarabadi MA, Berghmans B. Pelvic floor rehabilitation in the treatment of women with dyspareunia: a randomized controlled clinical trial. Int Urogynecol J. 2019 Nov;30(11):1849-1855. doi: 10.1007/s00192-019-04019-3. Epub 2019 Jul 8.
- Meyer-Bahlburg HF, Dolezal C. The female sexual function index: a methodological critique and suggestions for improvement. J Sex Marital Ther. 2007 May-Jun;33(3):217-24. doi: 10.1080/00926230701267852.
- Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235.
- Cline ME, Herman J, Shaw ER, Morton RD. Standardization of the visual analogue scale. Nurs Res. 1992 Nov-Dec;41(6):378-80. No abstract available.
- Trahan J, Leger E, Allen M, Koebele R, Yoffe MB, Simon C, Alappattu M, Figuers C. The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. J Womens Health Phys Therap. 2019 Jan-Mar;43(1):28-35. doi: 10.1097/jwh.0000000000000117.
- Fisher KA. Management of dyspareunia and associated levator ani muscle overactivity. Phys Ther. 2007 Jul;87(7):935-41. doi: 10.2522/ptj.20060168. Epub 2007 May 1.
- Antosh DD, Gutman RE, Park AJ, Sokol AI, Peterson JL, Kingsberg SA, Iglesia CB. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jun;121(6):1273-1280. doi: 10.1097/AOG.0b013e3182932ce2.
- Both S, Brauer M, Weijenborg P, Laan E. Effects of Aversive Classical Conditioning on Sexual Response in Women With Dyspareunia and Sexually Functional Controls. J Sex Med. 2017 May;14(5):687-701. doi: 10.1016/j.jsxm.2017.03.244. Epub 2017 Mar 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 15, 2023
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
May 4, 2023
First Posted (Actual)
May 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0526
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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