Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

Официальное название

Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial

Обзор

Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia. 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.

Подробное описание

Patients will be divided randomly into two groups equal in number:

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

Вмешательства

• Другое 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.
• Другое 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. T

Первичные конечные точки

• Assessment of pain intensity [Срок оценки: Ten weeks]
• Assessment of dyspareunia [Срок оценки: 10 Weeks]

Вторичные конечные точки (2)

• Assessment of sexual function [Срок оценки: Ten weeks]
• Assessment of quality of life [Срок оценки: Ten weeks]

Критерии участия

• Inclusion Criteria:

• Women complain of secondary dyspareunia, diagnosed and referred by the gynecologist.
• 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:

• Pregnancy
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy — Giza

Идентификаторы

NCT: NCT06730776 · P.T.REC/012/005373

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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