Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia
NCT ID: NCT06730776
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
38 participants
INTERVENTIONAL
2024-12-15
2025-05-30
Brief Summary
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Patients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.
Detailed Description
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Control group (Group A): It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity).
Study group (GroupB): It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). All females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group (group A)
It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity)
Topical medication
It will be given to all participants in both groups (A\&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity.
Study group (group B)
It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), topical medication(lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity)
Topical medication
It will be given to all participants in both groups (A\&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity.
Transcutaneous electrical acupoint stimulation
This procedure will be applied for group B only. Before starting the first treatment session, each patient will be instructed briefly about the nature of the treatment to gain the patient's confidence and cooperation. This procedure will be performed by using TENS device on acupoints as the following: The participating woman will be placed in a relaxed comfortable supine position with her back well supported. The surface of the treated skin and the electrodes will be cleaned with alcohol wipe. The TENS protocol consists of a 30-minute weekly. session for 10 weeks of biphasic pulses with modulation 0/10-50 Hz of frequency and 300/100/3000 microseconds of pulse duration (s). The intensity parameter will be adapted individually according to each woman's perception, and modulated so that it is applied without discomfort, ranging between 10 and 100 mA (pulsing sensation) (Dionisi and Senatori ,2011)
Interventions
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Topical medication
It will be given to all participants in both groups (A\&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity.
Transcutaneous electrical acupoint stimulation
This procedure will be applied for group B only. Before starting the first treatment session, each patient will be instructed briefly about the nature of the treatment to gain the patient's confidence and cooperation. This procedure will be performed by using TENS device on acupoints as the following: The participating woman will be placed in a relaxed comfortable supine position with her back well supported. The surface of the treated skin and the electrodes will be cleaned with alcohol wipe. The TENS protocol consists of a 30-minute weekly. session for 10 weeks of biphasic pulses with modulation 0/10-50 Hz of frequency and 300/100/3000 microseconds of pulse duration (s). The intensity parameter will be adapted individually according to each woman's perception, and modulated so that it is applied without discomfort, ranging between 10 and 100 mA (pulsing sensation) (Dionisi and Senatori ,2011)
Eligibility Criteria
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Inclusion Criteria
* Multiparous women.
* Their ages will range from 25-35 years.
* Their body BMI will be less than 35 kg/m².
* Their pain level on the VAS will be ≥ 4.
* All the women were negative for vaginal infections caused by viruses, bacteria or fungi.
Exclusion Criteria
* Malignancy.
* The presence of an intrauterine device, vaginal infection, or skin/mucous lesions.
* Diabetes mellitus.
* Dermatological abnormalities on the skin at acupuncture point.
* Severe uncontrolled cardiac patients or implanted cardiac rhythm devices.
* Dyspareunia with endometriosis.
* Fearing from electricity.
25 Years
35 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Marwa gamal abdelrahman ahmed
Master student at Faculty of Physical Therapy, Cairo University
Principal Investigators
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Doaa A Osman
Role: STUDY_CHAIR
Department of Women's Health, Faculty of Physical Therapy, Cairo University
Locations
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Faculty of Physical Therapy
Giza, Egypt, Egypt
Countries
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Central Contacts
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Facility Contacts
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Marwa GA Ahmed
Role: primary
Other Identifiers
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P.T.REC/012/005373
Identifier Type: -
Identifier Source: org_study_id