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EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05395156
Collaborator
(none)
50
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

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)?

Condition or Disease Intervention/Treatment Phase
  • Device: Transcutaneous electrical nerve stimulation (TENS)
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME
Anticipated Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Sep 10, 2022
Anticipated Study Completion Date :
Oct 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Device: 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
Experimental: 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.

Device: 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

Outcome Measures

Primary Outcome Measures

  1. pain severity [Up to 3 monthes]

    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

  2. premenstrual syndrome severity [up to 3 monthes]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aml Mohammed Elsayed Abdelaal, spicialist of physical therapy at talkha central hospital, Cairo University
ClinicalTrials.gov Identifier:
NCT05395156
Other Study ID Numbers:
  • P.T.REC/012/003688
First Posted:
May 27, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premenstrual Syndrome

Study Results

No Results Posted as of May 27, 2022