Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Dyspareunia (Female)
• Intervention / Treatment: Other: Topical medication; Other: Transcutaneous electrical acupoint stimulation

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

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa GA Ahmed; Phone Number: 01018637863; Email: marwagamal30594@gmail.com
• Study Contact Backup: Name: Manal A El-Shafei; Phone Number: 01220664518; Email: manal.ahmed@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12511
    • Faculty of Physical Therapy
    • Contact: Marwa GA Ahmed; Phone Number: 01018637863; Email: marwagamal30594@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	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.
Experimental: Study group (group B); 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; 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. 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Ten weeks
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.	Ten weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa A Osman, Department of Women's Health, Faculty of Physical Therapy, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): May 15, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: dyspareunia,
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Dyspareunia
• Other Study ID Numbers: P.T.REC/012/005373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No