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Clinical Trials in Egypt / NCT06730776
Starting soon Not applicable

Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

NCT06730776 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Not applicable
Started
2024-12-15
Last updated
2024-12-12

Condition(s) studied

Dyspareunia (Female)

Investigational drug(s) / intervention(s)

Topical medicationTranscutaneous electrical acupoint stimulation

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)

Study summary

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.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
35 Years
Healthy volunteers
No
* 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.

Primary outcome measure(s)

  • Assessment of pain intensity — Ten weeks
    Visual analogue scale (VAS) will be used to measure pain intensity for each female in both groups (A\&B). Each female will be asked to mark the point on the scale that represents her pain level.
  • Assessment of dyspareunia — 10 Weeks
    Marinoff Dyspareunia Scale will be used to evaluate vaginal and vulvar symptoms and pain related to sexual intercourse for both groups (A\& B) before and after the end of the treatment (10 weeks).

Trial sites (1)

FacilityCityRegionStatus
Faculty of Physical Therapy Giza Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06730776 on ClinicalTrials.gov ↗ ← All trials in Egypt