Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women

NCT ID: NCT06976151

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2025-10-10

Brief Summary

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This study will be conducted to investigate transcutaneous electrical acupoint stimulation effect on pain and disease aggravation during menstruation among autoimmune disease women

Detailed Description

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The monthly ovarian cycle is characterized by tightly regulated hormones predictably fluctuating throughout the reproductive years. The menstrual cycle plays a role in the exacerbation of rheumatologic conditions, such as rheumatoid arthritis and systemic lupus erythematosus, with flares occurring prior to and during menses, respectively Given these previous observations, sex hormones are hypothesized to influence the biologic properties of the immune system and skin.

Women with rheumatoid arthritis (RA) reported increased pain, fatigue, and disease activity right before their period. Furthermore, those with systemic lupus erythematosus (SLE) experienced similar symptom flares during menses.

The transcutaneous electrical acupoint stimulation (TEAS) is a combination of transcutaneous electrical nerve stimulation (TENS) and traditional Chi- nese acupoints. . Electroacupuncture blocks pain by activating a variety of bioactive chemicals through peripheral, spinal, and supraspinal mechanisms such as the prompt release of β-endorphin and met-enkephalin . Corticotrophin-releasing factor and prostaglandin E2 are also involved in electroacupuncture analgesia.

There are growing literature to support the relationship between the aggravation of autoimmune disease symptoms during menstruation time which maximizes the negative effect on the female's the daily activities at that time. There is lack of researches on the effect of TEAS on this point .TEAS has positive effect on pain during menstrual cycle . The result of this study will help to evaluate the efficacy of TEAS on Pain and disease severity during menstruation in women with autoimmune diseases.

Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medical treatment group

The participants will receive non-steroidal anti-inflammatory drugs (NSAID) for 3 consecutive menstrual cycle.

Group Type ACTIVE_COMPARATOR

Non-steroidal anti-inflammatory drugs (NSAID)

Intervention Type DRUG

The participants will receive non-steroidal anti- inflammatory drugs (NSAID), Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.

Transcutaneous Electrical Acupoint Stimulation (TEAS) group

The participants will receive Transcutaneous Electrical Acupoint Stimulation (TEAS), 3 days per week for 3 consecutive menstrual cycle.

Group Type EXPERIMENTAL

Non-steroidal anti-inflammatory drugs (NSAID)

Intervention Type DRUG

The participants will receive non-steroidal anti- inflammatory drugs (NSAID), Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.

Transcutaneous Electrical Acupoint Stimulation (TEAS)

Intervention Type OTHER

The participants will receive transcutaneous electrical acupoint Stimulation (TEAS). These acupoints will include large intestine 14 (LI4) , gall bladder 34 (GB34), large intestine 11 (LI11), Gall bladder 39 (GB39) and stomach 36 (ST 36). The session will be applied for 30 minutes / 3 days/ week, in addition to Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.

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Interventions

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Non-steroidal anti-inflammatory drugs (NSAID)

The participants will receive non-steroidal anti- inflammatory drugs (NSAID), Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.

Intervention Type DRUG

Transcutaneous Electrical Acupoint Stimulation (TEAS)

The participants will receive transcutaneous electrical acupoint Stimulation (TEAS). These acupoints will include large intestine 14 (LI4) , gall bladder 34 (GB34), large intestine 11 (LI11), Gall bladder 39 (GB39) and stomach 36 (ST 36). The session will be applied for 30 minutes / 3 days/ week, in addition to Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.

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Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All women will be diagnosed with Rheumatoid arthritis(RA) or Systemic lupus erythematosus (SLE).
* All women will suffer from severe pain during menstruation
* Age will range from 25-40 years old.
* Body mass index: 18.5- 30 Kg/m²
* All women participated in the study will have regular menstrual cycle

Exclusion Criteria

* Secondary dysmenorrhea
* Any other autoimmune diseases not mention in research
* Cardiac or respiratory diseases
* Vaginal infection
* Anemia diseases
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Lamiaa Mostafa Okeil

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia Kamel, Professor

Role: STUDY_DIRECTOR

Cairo University

Amel Youssef, Professor

Role: STUDY_CHAIR

Cairo University

Locations

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Lamiaa Mostafa Okeil

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Lamiaa Okeil, PHD

Role: CONTACT

+01021355033

Hossam Kamel, Professor

Role: CONTACT

201223141819

Other Identifiers

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P.T.REC/012/004759

Identifier Type: -

Identifier Source: org_study_id

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