Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dyspareunia (Female)

Treatments: Other: Transcutaneous electrical acupoint stimulation; Other: Topical medication

Study type: Interventional

Funder types: Other

Identifiers

NCT06730776

P.T.REC/012/005373

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Control group (group A)

Active Comparator group

Description:

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)

Treatment:

Other: Topical medication

Study group (group B)

Experimental group

Description:

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)

Treatment:

Other: Topical medication

Other: Transcutaneous electrical acupoint stimulation