EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

NCT ID: NCT05395156

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2022-10-10

Brief Summary

These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)?

Detailed Description

Premenstrual syndrome is a collection of emotional, physiological, and behavioral symptoms that develop around the end of the luteal phase and fade away with or after menstruation Due to limited evidence on the efficacy of sustained progesterone and the side effects of antidepressant and anxiolytics, in some cases, alternative therapies are recommended for patients with PMS TEAS may be more effective than other forms of transcutaneous electrical nerve stimulation (TENS) in modulating brain activity because acupoint areas contain relatively denser neural and neuroactive components than non-acupoint areas TEAS has been reported to have similar efficacy as acupuncture, electrical acupuncture, and TENS

Conditions

Premenstrual Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sham acupoint

Control group: (placebo group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on sham acupoint (the acupoint selection site was 1 inch away from the acupoint selection in the study group) daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

Control group will receive TEAS on sham acupoint daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles Study group will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles

Electroacupuncture

Study group: (Electroacupuncture group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months.

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

Control group will receive TEAS on sham acupoint daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles Study group will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles

Interventions

Transcutaneous electrical nerve stimulation (TENS)

Control group will receive TEAS on sham acupoint daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles Study group will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Their age will range from 18 to 25 years.
• The regularity of menstrual cycle is 28-35 days.
• All of them suffering from moderate and sever PMS.
• All participants are virgin.
• Their BMI will range from 25-30 kg\m2.

Exclusion Criteria

• Any pathological findings in the pelvic cavity as PCO, Endometriosis and pelvic inflammatory disease.
• Any history of gynecological intervention.
• Have any condition impedes the use of electrotherapy.
• Receiving sedatives or any medical treatment.
• Having irregular menstruation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aml Mohammed Elsayed Abdelaal

spicialist of physical therapy at talkha central hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Azza Barmoud, professor

Role: CONTACT

drazzakassab@yahoo.com

01008410312

Other Identifiers

P.T.REC/012/003688

Identifier Type: -

Identifier Source: org_study_id