[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547675":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":49,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":26,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Au-TENS group","EXPERIMENTAL","Women will receive acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA.",[13],"Device: Acu-TENS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham acu-TENS group","SHAM_COMPARATOR","Women will receive sham acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA. In the sham acu-TENS, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.",[19],"Device: Sham acu-TENS",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Acu-TENS","After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints SP6, ST36, LI4, LR3, according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 4-12mA, and pulse width of 300µS will be delivered continually for 45 minutes (i.e. from 15 minutes before starting the MVA to 15 minutes after the procedure has completed).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham acu-TENS","After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints SP6, ST36, LI4, LR3, according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair.\n\nIn the sham acu-TENS, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current. The pads will be stuck on the acupoints for 45 minutes (i.e. from 15 minutes before starting the MVA to 15 minutes after the procedure has completed).",[15],[32],{"facility":33,"status":34,"city":35,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Prince of Wales Hospital","RECRUITING","Hong Kong","HK",{"type":38,"coordinates":39},"Point",[40,41],114.17469,22.27832,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Pui Wah Jacqueline Chung, MD","CONTACT","3505 1537","jacquelinechung@cuhk.edu.hk",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Chung Pui Wah Jacqueline","Associate Professor","100547675","the-efficacy-of-acu-tens-as-an-adjunct-analgesic-during-usg-mva-100547675",false,"NCT06411054","The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA","The Efficacy of Acupuncture-type Transcutaneous Electrical Nerve Stimulation as an Adjunct Analgesic in Reducing Pain During Ultrasound-guided Manual Vacuum Aspiration: A Prospective, Single- Blinded Two-arm Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Aged 18 or above;\n2. Patient diagnosed with first-trimester miscarriage, who is eligible for USG-MVA;\n3. Patient diagnosed with incomplete miscarriage after medical treatment;\n4. Willing to be randomized to receive acupuncture.\n\nExclusion criteria\n\na. Patient not eligible for USG-MVA i. Miscarriage \\> 12 weeks of gestation; or ii. Pregnancy of unknown origin; or iii. Known narrowing of the cervical canal; or iv. Multiple uterine fibroids; or v. Congenital uterine anomalies; or vi. Active pelvic infection; or vii. Bleeding disorder; or viii. Inability to tolerate pelvic examination; or ix. History of allergy to misoprostol\n\nb. Patient not eligible for acu-TENS i. Poor skin integrity at the acupuncture site, such as open wound, infections, unknown mass, bleeding tendency; or ii. Allergic to external alcohol; or iii. Emotionally unstable or tend to restlessness (to avoid tear-off of pads).\n\nc. Patient refusal","FEMALE","18 Years",{"count":63,"type":64},108,"ESTIMATED","INTERVENTIONAL",[67],"NA","Objectives: To prospectively evaluate the potential of acu-TENS to reduce the pain experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) and evaluate its safety profile.\n\nHypothesis to be tested: Does the use of acu-TENS reduce pain in women undergoing USG-MVA?\n\nDesign and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology of the Prince of Wales Hospital. Women undergoing USG-MVA for the treatment of early pregnancy loss before 12 weeks of gestation will be randomized to receive acu-TENS (intervention group) or sham acu-TENS (control group) for pain control during USG-MVA. We will recruit 54 participants in each of the two arms, so a total of 108 patients will be recruited.\n\nStudy instruments: USG-MVA will be performed using a 60ml charged syringe (MedGyn Aspiration Kit) with a flexible curette attached to it. Transabdominal ultrasound during the MVA procedure will be performed using Mindray DC-80A Diagnostic Ultrasound System. Acu-TENS will be performed using MTR+ Myolito Multifunctional Stimulator (MTRP-00003).\n\nMain outcome measures: Primary outcome includes pain scores before, during and after USG-MVA. Secondary outcomes include (1) stress levels measured by heart rate, heart rate variability, blood pressure, State Trait Anxiety Inventory (STAI), and salivary cortisol; (2) anxiety level; (3) Surgeon's assessment on the patient co-operation score and patient intraoperative pain, (4) Client Satisfaction Questionnaire (CSQ8) and satisfaction score, and (5) any adverse events of acu-TENS.\n\nData analysis: Data analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc).\n\nExpected results: We expect that acu-TENS will result in at least a 35% reduction in pain experienced by women undergoing USG-MVA.",[70],"Pain, Acute",[72,73,74,75,76],"Manual vacuum aspiration","Ultrasound-guided","Acupuncture transcutaneous electrical nerve stimulation","Alternative medicine","Randomized controlled trial","2026-05-08",{"date":79,"type":80},"2026-05-12","ACTUAL",{"date":82,"type":80},"2024-06-01",{"date":84,"type":64},"2027-08-31",{"name":5,"class":6},1]