Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Genitio Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Soft Tissue Release With and Without Vaginal Dilators on Pain and Sexual Function in Women With Genito Pelvic Pain

Conditions
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Genito-Pelvic Pain/Penetration Disorder

Intervention / Treatment
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* Other: soft tissue release
* Other: vaginal dilators


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soft tissue release with vaginal dilators<br>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 | Other: soft tissue release<br>* 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.<br>Other: vaginal dilators<br>* Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones.<br>|
| Active Comparator: soft tissue release only<br>will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage | Other: soft tissue release<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female sexual function index | 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 | 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 | 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 |