search
Back to results

EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

Primary Purpose

Premenstrual Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Pain

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    sham acupoint

    Electroacupuncture

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05395156
    Brief Title
    EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME
    Official Title
    EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 10, 2022 (Anticipated)
    Primary Completion Date
    September 10, 2022 (Anticipated)
    Study Completion Date
    October 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sham acupoint
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Electroacupuncture
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous electrical nerve stimulation (TENS)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    pain severity
    Description
    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
    Time Frame
    Up to 3 monthes
    Title
    premenstrual syndrome severity
    Description
    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
    Time Frame
    up to 3 monthes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Azza Barmoud, professor
    Phone
    01008410312
    Email
    drazzakassab@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

    We'll reach out to this number within 24 hrs