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

NCT06976151 | Completed

• 1 other identifier: P.T.REC/012/004759
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (5)

• 10 meter walk test

  Each woman in both groups will receive the 10 meter walk test to determine functional mobility, gait, and vestibular function. Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. Normative Values, age 20-29 years : Average Walking Speed(m/s): 1.36-1.34 m/s, age: 30-39 years: Average Walking Speed(m/s):1.43-1.34 m/s.

  3 months

• Assessment of degree of pain

  Each woman in both groups will have visual analogue scale (VAS) for conducting of degree of pain in joints just before and during menstruation for 3 consecutive menstruation. It is pointed from 0 to 10 , 0 means no pain and 10 is worst pain

  3 months

• Erythrocyte sedumntation rate (ESR)

  It is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. The blood samples will be collected at the beginning and after the end of treatment procedures to detect the level of inflammation for both groups. normal value ranges from 0 to 20 mm/hr.

  3 months

• C-reactive protein (CRP)

  It is a substance the liver produces in response to inflammation. The blood samples will be collected at the beginning and after the end of treatment procedures to detect the level of inflammation for both groups. Normal value is less than 0.9 mg/dl.

  3 months

• Pain disability index (PDI)

  The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. I t includes the following items family and home responsibilities, recreation, social activity, occupation, self care, and life-support activity. It is scored from 0 to 10. 0 means no disability and 10 means worst disability.

  3 months

Study Arms (2)

Medical treatment group

ACTIVE COMPARATOR

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

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

Transcutaneous Electrical Acupoint Stimulation (TEAS) group

EXPERIMENTAL

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

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

Interventions

Non-steroidal anti-inflammatory drugs (NSAID) DRUG

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

Medical treatment group; Transcutaneous Electrical Acupoint Stimulation (TEAS) group

Transcutaneous Electrical Acupoint Stimulation (TEAS) 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. .

Transcutaneous Electrical Acupoint Stimulation (TEAS) group

Eligibility Criteria

• Age: 25 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Secondary dysmenorrhea
• Any other autoimmune diseases not mention in research
• Cardiac or respiratory diseases
• Vaginal infection
• Anemia diseases

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Lamiaa Mostafa Okeil

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Dalia Kamel, Professor

  Cairo University

  STUDY DIRECTOR

• Amel Youssef, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: May 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

EG (1)