Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

NCT06730776 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005373
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspareunia (Female)

Keywords

dyspareunia,

Outcome Measures

Primary Outcomes (2)

• 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.

  Ten weeks

• 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).

  10 Weeks

Secondary Outcomes (2)

• Assessment of sexual function

  Ten weeks

• Assessment of quality of life

  Ten weeks

Study Arms (2)

Control group (group A)

ACTIVE COMPARATOR

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)

Other: Topical medication

Study group (group B)

EXPERIMENTAL

It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), topical medication(lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity)

Other: Topical medication; Other: Transcutaneous electrical acupoint stimulation

Interventions

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.

Control group (group A); Study group (group B)

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)

Study group (group B)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt, 12511, Egypt

Location

MeSH Terms

Conditions

Dyspareunia

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Doaa A Osman

  Department of Women's Health, Faculty of Physical Therapy, Cairo University

  STUDY CHAIR

Central Study Contacts

Marwa GA Ahmed

CONTACT

01018637863; marwagamal30594@gmail.com

Manal A El-Shafei

CONTACT

01220664518; manal.ahmed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student at Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: December 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 30, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)