Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

Official title

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

Overview

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.

Detailed description

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

Interventions

• Other 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.
• Other 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

Primary outcome measures

• Assessment of pain intensity [Time frame: Ten weeks]
• Assessment of dyspareunia [Time frame: 10 Weeks]

Secondary outcome measures (2)

• Assessment of sexual function [Time frame: Ten weeks]
• Assessment of quality of life [Time frame: Ten weeks]

Eligibility criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy — Giza

Identifiers

NCT: NCT06730776 · P.T.REC/012/005373

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗