NCT05799924

Brief Summary

The goal of this clinical trial is to investigate the use of TEAS on female patients with dysmenorrhea. The main questions it aims to answer are: Questions 1：Effect of TEAS on dysmenorrhea Questions 2：Mechanism of TEAS in treatment of dysmenorrhea Participants will wear TEAS devices to treat dysmenorrhea during menstruation The participants in the control group were treated with oral medication for dysmenorrhea

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

February 21, 2023

Last Update Submit

April 4, 2023

Conditions

Dysmenorrhea

Keywords

DysmenorrheaacupunctureTEAS

Outcome Measures

Primary Outcomes (4)

  • Visual Analogue Scale

    The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with a total score of 0-10, and the greater the number, the more severe the pain.

    six months

  • the Cox Menstrual Symptom Scale

    The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.

    six months

  • Work Productivity and Activity Impairment

    The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.

    six months

  • Hamilton Anxiety Scale

    The self-rating scale was used to describe the changes of dysmenorrhea symptoms before and after the intervention, with the total score ranging from 0 to 100. The greater the number, the more severe the pain.

    six months

Secondary Outcomes (4)

  • Changes in prostaglandins secretion level

    six months

  • Changes in β-endorphin level

    six months

  • Changes in Nitric Oxide level

    six months

  • Changes in endothelin level

    six months

Study Arms (2)

Women with dysmenorrhea treated with TEAS

EXPERIMENTAL

The transcutaneous electrical acupoint stimulator applied alternating current (including sine wave, pulse wave and modulation wave) with frequency of 2 \~ 100Hz and intensity of 10-20mA to stimulate corresponding acupoints through skin electrodes. The stimulated acupoints include Hegu acupoints, Luogong acupoints, Neiguan acupoints and Waiguan acupoints.

Device: Transcutaneous electrical acupoint stimulation

Women with dysmenorrhea receiving medication

ACTIVE COMPARATOR

Take NSAIDs or birth control pills every six hours during your period when you feel unbearable pain.

Drug: non steroidal anti inflammatory drugs

Interventions

Transcutaneous electrical acupoint stimulationDEVICE

The transcutaneous electrical acupoint stimulator applied alternating current (including sine wave, pulse wave and modulation wave) with frequency of 2 \~ 100Hz and intensity of 10-20mA to stimulate corresponding acupoints through skin electrodes. The stimulated acupoints include Hegu acupoints, Luogong acupoints, Neiguan acupoints and Waiguan acupoints.

Women with dysmenorrhea treated with TEAS
non steroidal anti inflammatory drugsDRUG

Hormonal contraception can suppress ovulation, NSAIDS can ease pain

Also known as: Short-acting birth control pills
Women with dysmenorrhea receiving medication

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • there are symptoms of dysmenorrhea, the duration is more than or equal to 6 months；
  • regular menstruation, menstrual cycle 21 \~ 35 days, menstrual period 3 \~ 7 days.

You may not qualify if:

  • dysmenorrhea caused by abnormality and obstruction of reproductive tract；
  • preparing for pregnancy or being pregnant；
  • endometriosis or adenomyosis with surgical indication；
  • taking NSAIDs within one month or receiving immunosuppressive therapy within three months；
  • implantation of pacemaker or other implanted medical electronic devices；
  • high frequency surgical equipment, artificial heart and lung, medical shortwave and microwave therapeutic apparatus were used；
  • scarring or skin damage at the site of irritation；
  • refused to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Related Publications (5)

  • Proctor M, Farquhar C. Diagnosis and management of dysmenorrhoea. BMJ. 2006 May 13;332(7550):1134-8. doi: 10.1136/bmj.332.7550.1134. No abstract available.

    PMID: 16690671BACKGROUND

  • Nasir L, Bope ET. Management of pelvic pain from dysmenorrhea or endometriosis. J Am Board Fam Pract. 2004 Nov-Dec;17 Suppl:S43-7. doi: 10.3122/jabfm.17.suppl_1.s43.

    PMID: 15575029BACKGROUND

  • Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.

    PMID: 16824213BACKGROUND

  • Jamieson DJ, Steege JF. The prevalence of dysmenorrhea, dyspareunia, pelvic pain, and irritable bowel syndrome in primary care practices. Obstet Gynecol. 1996 Jan;87(1):55-8. doi: 10.1016/0029-7844(95)00360-6.

    PMID: 8532266BACKGROUND

  • Banikarim C, Chacko MR, Kelder SH. Prevalence and impact of dysmenorrhea on Hispanic female adolescents. Arch Pediatr Adolesc Med. 2000 Dec;154(12):1226-9. doi: 10.1001/archpedi.154.12.1226.

    PMID: 11115307BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Honglan Zhu, M.D

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Honglan Zhu, M.D

CONTACT

13661316849honglanzhu01@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician，OBGYN

Study Record Dates

First Submitted

February 21, 2023

First Posted

April 5, 2023

Study Start

February 21, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)