EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

NCT05395156 | Unknown

• 1 other identifier: P.T.REC/012/003688
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Premenstrual Pain

Outcome Measures

Primary Outcomes (2)

• pain severity

  The pain intensity will be assessed through visual analogue scale (VAS) for each participant in both groups before and after treatment Each participant will be asked to mark a point on VAS line between the extremes that related to her current pain intensity

  Up to 3 monthes

• premenstrual syndrome severity

  Participants can differentiate between their experiences of different symptoms during menstrual cycle and they will be assessed before and after treatment using the Menstrual Distress Questionnaire (MDQ) Each participant will be asked to rate their experience of each of the symptoms on the MDQ on a scale ranging from no experience of the symptom to an acute or partially disabling experience of the symptom

  up to 3 monthes

Study Arms (2)

sham acupoint

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation (TENS)

Electroacupuncture

EXPERIMENTAL

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.

Device: Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) 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; sham acupoint

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Azza Barmoud, professor

CONTACT

01008410312; drazzakassab@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: spicialist of physical therapy at talkha central hospital

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: June 10, 2022
• Primary Completion: September 10, 2022
• Study Completion: October 10, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF