Clinical trial NCT06730776: Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dyspareunia (Female)
Keywords: dyspareunia,
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 38
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Assessment of pain intensity
timeFrame: Ten weeks
measure: Assessment of dyspareunia
timeFrame: 10 Weeks
Secondary outcomes:
measure: Assessment of sexual function
timeFrame: Ten weeks
measure: Assessment of quality of life
timeFrame: Ten weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Department of Women's Health, Faculty of Physical Therapy, Cairo University
name: Doaa A Osman
role: STUDY_CHAIR
References: