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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soft tissue release with vaginal dilators | Experimental | 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 |
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| soft tissue release only | Active Comparator | will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soft tissue release | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• History of pathological conditions like infections
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| Name | Affiliation | Role |
|---|---|---|
| Asma Ambreen, MS* | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahore general hospital | Lahore | Punjab Province | 54700 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16021067 | Background | 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. | |
| 34135723 | Background | 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. |
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| vaginal dilators | Other | Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones. |
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| 17472951 | Background | 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. |
| 23812462 | Background | 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. |
| 16020150 | Background | Rosenbaum TY. Physiotherapy treatment of sexual pain disorders. J Sex Marital Ther. 2005 Jul-Sep;31(4):329-40. doi: 10.1080/00926230590950235. |
| 28372937 | Background | 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. |
| 31286158 | Background | 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. |
| 17454519 | Background | 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. |
| 1437591 | Background | 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. |