Autoimmune DiseasesNCT06976151
Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
A study testing Non-steroidal anti-inflammatory drugs (NSAID) and Transcutaneous Electrical Acupoint Stimulation (TEAS) in people with Autoimmune Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate transcutaneous electrical acupoint stimulation effect on pain and disease aggravation during menstruation among autoimmune disease women Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Non-steroidal anti-inflammatory drugs (NSAID) and Transcutaneous Electrical Acupoint Stimulation (TEAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Secondary dysmenorrhea
- Any other autoimmune diseases not mention in research
- Cardiac or respiratory diseases
- Vaginal infection
- Anemia diseases
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to investigate transcutaneous electrical acupoint stimulation effect on pain and disease aggravation during menstruation among autoimmune disease women
Read the 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.
- Conditions
- Autoimmune Diseases
- Being tested
- Non-steroidal anti-inflammatory drugs (NSAID), Transcutaneous Electrical Acupoint Stimulation (TEAS)
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment group | Active comparator | The participants will receive non-steroidal anti-inflammatory drugs (NSAID) for 3 consecutive menstrual cycle. Receives: 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. Receives: Drug: Non-steroidal anti-inflammatory drugs (NSAID); Other: Transcutaneous Electrical Acupoint Stimulation (TEAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 May 2025
- Primary completion20 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Mostafa Okeil, Cairo University
- Investigators
- Dalia Kamel, Professor, Study director, Cairo UniversityAmel Youssef, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976151
- Sponsor's protocol ID
- P.T.REC/012/004759
- Status last verified
- Apr 2026
- First submitted
- 9 May 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
- ClinicalTrials.gov ID
- NCT06976151
- Acronym / sponsor ID
- P.T.REC/012/004759
- Conditions
- Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment group | Active comparator | Drug: Non-steroidal anti-inflammatory drugs (NSAID)The participants will receive non-steroidal anti-inflammatory drugs (NSAID) for 3 consecutive menstrual cycle. |
| Transcutaneous Electrical Acupoint Stimulation (TEAS) group | Experimental | Drug: Non-steroidal anti-inflammatory drugs (NSAID), Other: Transcutaneous Electrical Acupoint Stimulation (TEAS)The participants will receive Transcutaneous Electrical Acupoint Stimulation (TEAS), 3 days per week for 3 consecutive menstrual cycle. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Secondary dysmenorrhea
- Any other autoimmune diseases not mention in research
- Cardiac or respiratory diseases
- Vaginal infection
- Anemia diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Medical treatment group, Transcutaneous Electrical Acupoint Stimulation (TEAS) group |
| 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. . | Other | Transcutaneous Electrical Acupoint Stimulation (TEAS) group |
Primary outcome
10 meter walk test
Time frame: 3 months
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.
Assessment of degree of pain
Time frame: 3 months
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
Erythrocyte sedumntation rate (ESR)
Time frame: 3 months
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.
C-reactive protein (CRP)
Time frame: 3 months
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.
Pain disability index (PDI)
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Kamel, Professor study director
Cairo University
Amel Youssef, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-steroidal anti-inflammatory drugs (NSAID) and Transcutaneous Electrical Acupoint Stimulation (TEAS) in people with Autoimmune Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.