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NCT Number: NCT06730776

Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

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.

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Topical medication

Other

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

Other

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)

Primary outcomes

  1. Assessment of pain intensity

    Time frame: 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.

  2. Assessment of dyspareunia

    Time frame: 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).

Secondary outcomes

  1. Assessment of sexual function

    Time frame: Ten weeks

    The female sexual function index will be used to evaluate sexual function including (desire, arousal, lubrication, satisfaction, and orgasm) for all women with dyspareunia in both groups (A& B) before and after the end of the treatment.

  2. Assessment of quality of life

    Time frame: Ten weeks

    Sexual quality of life-female (SQOL-F) questionnaire will be used to evaluate quality of life for all women with dyspareunia in both groups (A&B) before and after the end of the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Manal A El-Shafei

CONTACT

[email protected]

01220664518

Marwa GA Ahmed

CONTACT

[email protected]

01018637863

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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