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Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

ConditionDyspareunia (Female)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-35
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy

Malignancy.

The presence of an intrauterine device, vaginal infection, or skin/mucous lesions.

Diabetes mellitus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Topical medication

    Other intervention

    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 intervention

    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)

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Control group (group A)Active comparator 1 intervention
Group B: Study group (group B)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assessment of pain intensity

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.

Time frame
Ten weeks
2

Assessment of dyspareunia

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).

Time frame
10 Weeks

Secondary outcomes

1

Assessment of sexual function

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.

Time frame
Ten weeks
2

Assessment of quality of life

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.

Time frame
Ten weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: