Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-02 @ 12:01 AM
Study NCT ID:
NCT06976151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '10 meter walk test', 'timeFrame': '3 months', 'description': 'Each woman in both groups will receive the 10 meter walk test to determine functional mobility, gait, and vestibular function.\n\nCalculating 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.'}, {'measure': 'Assessment of degree of pain', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Erythrocyte sedumntation rate (ESR)', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Pain disability index (PDI)', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigate transcutaneous electrical acupoint stimulation effect on pain and disease aggravation during menstruation among autoimmune disease women', 'detailedDescription': "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.\n\nWomen 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.\n\nThe 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.\n\nThere 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women will be diagnosed with Rheumatoid arthritis(RA) or Systemic lupus erythematosus (SLE).\n* All women will suffer from severe pain during menstruation\n* Age will range from 25-40 years old.\n* Body mass index: 18.5- 30 Kg/m²\n* All women participated in the study will have regular menstrual cycle\n\nExclusion Criteria:\n\n* Secondary dysmenorrhea\n* Any other autoimmune diseases not mention in research\n* Cardiac or respiratory diseases\n* Vaginal infection\n* Anemia diseases'}, 'identificationModule': {'nctId': 'NCT06976151', 'briefTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medical treatment group', 'description': 'The participants will receive non-steroidal anti-inflammatory drugs (NSAID) for 3 consecutive menstrual cycle.', 'interventionNames': ['Drug: Non-steroidal anti-inflammatory drugs (NSAID)']}, {'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Electrical Acupoint Stimulation (TEAS) group', 'description': 'The participants will receive Transcutaneous Electrical Acupoint Stimulation (TEAS), 3 days per week for 3 consecutive menstrual cycle.', 'interventionNames': ['Drug: Non-steroidal anti-inflammatory drugs (NSAID)', 'Other: Transcutaneous Electrical Acupoint Stimulation (TEAS)']}], 'interventions': [{'name': 'Non-steroidal anti-inflammatory drugs (NSAID)', 'type': 'DRUG', 'description': 'The participants will receive non-steroidal anti- inflammatory drugs (NSAID), Diclofenac 20 mg/ day for 3 consecutive menstrual cycles.', 'armGroupLabels': ['Medical treatment group', 'Transcutaneous Electrical Acupoint Stimulation (TEAS) group']}, {'name': 'Transcutaneous Electrical Acupoint Stimulation (TEAS)', 'type': 'OTHER', 'description': '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.\n\n.', 'armGroupLabels': ['Transcutaneous Electrical Acupoint Stimulation (TEAS) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Lamiaa Mostafa Okeil', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'centralContacts': [{'name': 'Lamiaa Okeil, PHD', 'role': 'CONTACT', 'email': 'lamiaaokiel@gmail.com', 'phone': '+01021355033'}, {'name': 'Hossam Kamel, Professor', 'role': 'CONTACT', 'email': 'hossamaldin1962@gmail.com', 'phone': '201223141819'}], 'overallOfficials': [{'name': 'Dalia Kamel, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Amel Youssef, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lamiaa Mostafa Okeil', 'investigatorAffiliation': 'Cairo University'}}}}