[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653697":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":37,"studyPopulation":28,"armGroups":38,"interventions":51,"overallOfficials":28,"centralContacts":61,"locations":67,"responsibleParty":112,"collaborators":28,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":28,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":70,"whyStopped":28,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Ilsan Cha hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Brief pain inventory-Korean version (BPI-K)","Change in BPI-K measured at the Visit 13 relative to baseline. Scores range from 0 to 10, with higher scores indicating greater pain severity or pain-related interference and therefore worse outcomes.","visit 13 (week 6)",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Change in Brief pain inventory-Korean version (BPI-K) at weeks 10","Change in BPI-K measured at Visit 14 relative to baseline.","visit 14 (week 10)",{"measure":19,"description":20,"timeFrame":21},"shoulder disability questionnaire (SDQ)","SDQ measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. Scores range from 0 (no disability) to 100 (maximum disability), reflecting the percentage of painful or limited activities. Higher score means worse outcome.","visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)",{"measure":23,"description":24,"timeFrame":21},"Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)","WOMAC measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. It uses 24 items scored on a 0 to 4 Likert scale, where higher scores indicate worse symptoms.",{"measure":26,"description":27,"timeFrame":21},"European Organization for Research and Treatment of Cancer - quality of life questionnaire - core 30 (EORTC-QLQ-C30)","EORTC-QLQ-C30 measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. Standardized scores range from 0 to 100 per each category.",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":28,"primaryPurpose":32,"observationalModel":28,"timePerspective":28,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":28,"whoMasked":35},"SINGLE",[36],"OUTCOMES_ASSESSOR","This is a pragmatic clinical study designed to compare and evaluate the efficacy, safety, and cost-effectiveness of pharmacopuncture treatment versus a control group in breast cancer patients (aged 19-75) suffering from aromatase inhibitor (AI)-induced arthralgia.\n\nAromatase inhibitors are required for a significant number of patients with hormone-receptor-positive breast cancer, and it is known that 50-96% of these patients experience associated arthralgia. While acupuncture is known to be effective for this condition, the efficacy of pharmacopuncture remains unknown; therefore, this study aims to investigate the utility of pharmacopuncture for AI-induced arthralgia.\n\nIf assigned to the control group, you will receive necessary analgesics-such as acetaminophen, NSAIDs, tramadol, analgesics for rheumatoid arthritis, or neuropathic pain medications-based on the clinician's judgement. If assigned to the treatment group, you will receive pharmacopuncture treatment in addition to the aforementioned conventional medications.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Pharmacopuncture group","EXPERIMENTAL","Participants in this group will receive pharmacopuncture treatment alongside standard treatment twice a week for a total of six weeks.\n\nUnder the autonomous judgment of the clinician, appropriate pharmacopuncture fluid and dosage shall be selected and administered to areas deemed effective for improving the study subjects' symptoms; the acupoints, types of pharmacopuncture fluid, and dosages shall be separately noted. The procedure shall be performed by a licensed Korean medicine practitioner who has held the license for at least 5 years.\n\nFor example:\n\n* Upper Extremity Pain\n\n  1. Shoulder: LI15, SJ14, SI9, SI10\n  2. Scapula: SI11, SI12, SI14, UB43\n  3. Elbow: LI11, LU5, SJ10), SJ5, LI4\n  4. Hand\u002FFingers: SI3, LI3, EX-UE9s\n* Lower Extremity Pain\n\n  1. Hip: GB30, UB37, GB29\n  2. Knee: ST34, ST35, GB34, GB35, Sp9\n  3. Leg: UB57, UB58\n  4. Ankle: St41, SP5, GB40, UB60, KI3\n  5. Foot\u002FToe: SP4, UB65, EX-UE10s",[44],"Procedure: pharmacopuncture therapy",{"label":46,"type":47,"description":48,"interventionNames":49},"Control group","ACTIVE_COMPARATOR","Administration of drugs according to the clinician's judgement from the drug classifications below\n\n1. NSAIDs\n2. Analgesics not subject to study exclusion criteria\n\n   \\- Acetaminophen, Ibuprofen, COX 2 inhibitors, Tramadol, etc.\n3. Neuropathic drugs - ATC code M01, M02, M03, N02, N03; gabapentin, pregabalin, N06; duloxetine, etc.",[50],"Procedure: Conventional therapy",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":28},"PROCEDURE","pharmacopuncture therapy","It is a modified form of acupuncture treatment in which a small amount of herbal medicine is inserted into acupoints. It is injected using sterile disposable tools.",[40],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":28},"Conventional therapy","Based on the clinician's judgement, prescriptions are made within the acceptable dosage range of drugs that are currently recommended in clinical practice. The prescription will be made by a hematology-oncology specialist with more than 10 years of experience.",[46],[62],{"name":63,"role":64,"phone":65,"phoneExt":28,"email":66},"Jee Young Lee","CONTACT","+82148717520","happiade@chamc.co.kr",[68,85,98],{"facility":69,"status":70,"city":71,"state":71,"zip":72,"country":73,"countryCode":28,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Daejeon University Daejeon Korean Medicine Hospital","RECRUITING","Daejeon","35235","South Korea",{"type":75,"coordinates":76},"Point",[77,78],127.38493,36.34913,{"lat":78,"lon":77},[81],{"name":82,"role":64,"phone":83,"phoneExt":28,"email":84},"Hwa Seung Yoo","082-10-8232-2752","altyhs@dju.ac.kr",{"facility":86,"status":70,"city":87,"state":88,"zip":89,"country":73,"countryCode":28,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Cha Ilsan Medical Center","Goyang-si","Gyeonggi-do","10414",{"type":75,"coordinates":91},[92,93],126.835,37.65639,{"lat":93,"lon":92},[96],{"name":63,"role":64,"phone":97,"phoneExt":28,"email":66},"082-10-4871-7520",{"facility":99,"status":70,"city":100,"state":100,"zip":101,"country":73,"countryCode":28,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Catholic Kwandong University International St. Mary's Hospital","Incheon","22711",{"type":75,"coordinates":103},[104,105],126.70515,37.45646,{"lat":105,"lon":104},[108],{"name":109,"role":64,"phone":110,"phoneExt":28,"email":111},"Tae Yong Park","082-10-3624-9539","parktae9822@daum.net",{"type":113,"investigatorFullName":63,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100653697","pharmacopuncture-for-aromatase-inhibitor-induced-arthralgia-aia-100653697",false,"NCT07789717","Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)","Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA) on Effectiveness, Safety, and Cost-Effectiveness in Patients With Breast Cancer : An Open-Label, Assessor-Blinded, Pragmatic Randomized Controlled Pilot Trial","P-ATx for AIA","Inclusion Criteria:\n\n1. Women aged 19 to 75 years\n2. Individuals diagnosed with localized or limited-stage hormone receptor-positive breast cancer who require the use of aromatase inhibitors\n3. Patients who have experienced new onset or worsening of joint pain after aromatase inhibitor treatment\n4. Individuals whose joint pain symptoms have persisted for at least 2 months\n5. Patients who reported joint pain of 3 or higher on the BPI-K (Korean version of the Brief Pain Inventory) during the past week at the time of screening.\n6. Patients who can read the symptom questionnaire, understand its meaning, and answer the questions.\n7. Patients who have voluntarily consented to the clinical plan and follow-up in writing, as approved by the Institutional Investigation Board (IRB).\n\nExclusion Criteria:\n\n1. Patients with Stage IV (metastatic) breast cancer.\n2. Within one month of the completion of surgery, chemotherapy, or radiation therapy (provided that chemotherapy is limited to cytotoxic chemotherapy).\n3. Those who have received intramuscular corticosteroids or intra-articular steroid injections within 4 weeks (28 days) of the screening time in relation to joint pain symptoms.\n4. Those who have received oral corticosteroids, opioid analgesics, topical analgesics, acupuncture, alternative medicine treatments, or physical therapy within 1 week (7 days) of the screening time in relation to joint pain symptoms.\n5. Those who plan to initiate new drug treatments (e.g., steroids) or invasive procedures (e.g., intra-articular injections) that may affect AIA during the study period.\n6. Individuals with active inflammatory joint diseases (rheumatoid arthritis, lupus, ankylosing spondylitis, etc.), metabolic joint diseases (gout, etc.), fibromyalgia, or other clear causes of joint pain (however, a history of osteoarthritis is not excluded).\n7. Cases where acupuncture or pharmacopuncture is contraindicated (severe hemorrhagic disease, severe aversion or fear of invasive treatment).\n8. Patients with a history of fracture within the last 6 months or who have undergone surgery on joints such as the knee or hand.\n9. Cases of uncontrolled severe mental illness or cognitive impairment.\n10. Cases with other diseases or factors deemed inappropriate for the clinical trial.\n11. Individuals participating in another clinical study within 4 weeks (28 days) prior to the clinical study screening.","FEMALE","19 Years","75 Years",{"count":127,"type":128},30,"ESTIMATED","INTERVENTIONAL",[131],"NA","This is a pragmatic pilot trial designed to compare and evaluate the efficacy, safety, and cost-effectiveness of pharmacopuncture treatment versus a control group in aromatase inhibitor-induced arthralgia patients with breast cancer.",[134,135,136],"Breast Cancer","Aromatase Inhibitor","Aromatase Inhibitor Induced Arthralgia",[138,139],"aromatase inhibitor induced arthralgia","pharmacopuncture","2026-09-09",{"date":142,"type":143},"2026-09-11","ACTUAL",{"date":145,"type":143},"2026-01-05",{"date":147,"type":128},"2027-12-31",{"name":5,"class":6},3]