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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Autoimmune Diseases

Treatments: Drug: Non-steroidal anti-inflammatory drugs (NSAID); Other: Transcutaneous Electrical Acupoint Stimulation (TEAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06976151

P.T.REC/012/004759

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Medical treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Non-steroidal anti-inflammatory drugs (NSAID)

Transcutaneous Electrical Acupoint Stimulation (TEAS) group

Experimental group

Description:

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

Treatment:

Other: Transcutaneous Electrical Acupoint Stimulation (TEAS)

Drug: Non-steroidal anti-inflammatory drugs (NSAID)