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

NCT ID: NCT05857826

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2023-09-15

Brief Summary

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

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.

Conditions

Genito-Pelvic Pain/Penetration Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

soft tissue release

Intervention Type: 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.

vaginal dilators

Intervention Type: OTHER

Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones.

soft tissue release only

will receive only soft tissue release using trigger point release vaginally or rectally and deep intervaginal massage

Group Type: ACTIVE_COMPARATOR

soft tissue release

Intervention Type: 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.

Interventions

soft tissue release

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.

Intervention Type: OTHER

vaginal dilators

Vaginal dilators will be used according to the patient's condition starting from small sizes to the wider ones.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asma Ambreen, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Lahore general hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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Other Identifiers

REC/RCR & AHS/23/0526

Identifier Type: -

Identifier Source: org_study_id