Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

Not Applicable

Not yet recruiting

• Conditions: Dyspareunia (Female)

• Registration Number: NCT06730776
• Lead Sponsor: Cairo University

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Study Start: 2024-12-15
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of pain intensity	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.
Assessment of dyspareunia	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 Outcome Measures

Name	Time	Method
Assessment of sexual function	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.
Assessment of quality of life	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.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Egypt