Clinical trial NCT06976151: Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autoimmune Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 10 meter walk test
timeFrame: 3 months
measure: Assessment of degree of pain
timeFrame: 3 months
measure: Erythrocyte sedumntation rate (ESR)
timeFrame: 3 months
measure: C-reactive protein (CRP)
timeFrame: 3 months
measure: Pain disability index (PDI)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Lamiaa Mostafa Okeil
Study officials:
affiliation: Cairo University
name: Dalia Kamel, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Amel Youssef, Professor
role: STUDY_CHAIR
References: