[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575914":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":81,"collaborators":36,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":36,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":36,"enrollmentInfo":93,"targetDuration":36,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":64,"whyStopped":36,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Zhangjiagang First People's Hospital","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"\"Active intradermal acupuncture\" plus \"Guided self-rehabilitation management program\"","EXPERIMENTAL","Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).\n\nParticipants will be taught and corrected self-rehabilitation techniques by Physical Medicine and Rehabilitation(PMR) therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.",[13,14],"Device: Active Intradermal Acupuncture","Other: Guided self-rehabilitation management program",{"label":16,"type":10,"description":17,"interventionNames":18},"\"Active intradermal acupuncture\" plus \"Health education\"","Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks).\n\nParticipants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.",[13,19],"Other: Health Education",{"label":21,"type":10,"description":22,"interventionNames":23},"\"Sham intradermal acupuncture\" plus \"Guided self-rehabilitation management program\"","Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).\n\nParticipants will be taught and corrected self-rehabilitation techniques by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.",[24,14],"Device: Sham Intradermal Acupuncture",{"label":26,"type":27,"description":28,"interventionNames":29},"\"Sham intradermal acupuncture\" plus \"Health education\"","SHAM_COMPARATOR","Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks).\n\nParticipants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.",[24,19],[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Active Intradermal Acupuncture","Depending on acupoints' location, φ0.20\\*1.5mm or φ0.20\\*1.2mm AIA will be selected. Insert the Active IA vertically into the acupoint and retain it in the skin.\n\nActive IA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be required to press the Active IA 4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours.",[9,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Sham Intradermal Acupuncture","Sham intradermal acupuncture will be attached to the acupoints and retained for 72 hours with a day's rest after removal. During the period of sham needle retention,pressing times and frequencies are identical to those in the active intradermal acupuncture group.",[21,26],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Guided self-rehabilitation management program","Self-rehabilitation techniques are taught in individual sessions of about 40 minutes at each outpatient clinic visit, as detailed below: Analysis of the problem, Education, Massage, Facial muscles exercise,Synkinesis or spasticity management, Homework. Participants are requested to perform daily facial muscle exercises as prescribed by the therapist and keep the written diary on a daily basis. The therapists retrieve and evaluate the diaries at each visit.",[9,21],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Health Education","Health education knowledge about the disease such as etiology, pathology,clinical symptoms of Bell's palsy, Bell's palsy diagnosis and role of medical tests;medication education;complications and sequelae,etc",[16,26],[50],{"name":51,"affiliation":5,"role":52},"yang Jiang, master","PRINCIPAL_INVESTIGATOR",[54,58],{"name":51,"role":55,"phone":56,"phoneExt":36,"email":57},"CONTACT","17768069362","17768069362@163.com",{"name":59,"role":55,"phone":60,"phoneExt":36,"email":61},"Dan Zhang, bachelor","18662237567","18662237567@163.com",[63],{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"RECRUITING","Suzhou","Jiangsu","215600","China","CN",{"type":71,"coordinates":72},"Point",[73,74],120.59538,31.30408,{"lat":74,"lon":73},[77,80],{"name":78,"role":55,"phone":79,"phoneExt":36,"email":57},"Yang Jiang, Master","+8617768069362",{"name":59,"role":55,"phone":60,"phoneExt":36,"email":61},{"type":52,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Yang Jiang","Principal Investigator","100575914","intradermal-acupuncture-and-self-rehabilitation-program-in-patients-with-severe-bells-palsy-100575914",false,"NCT06778473","Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy","Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial","Inclusion Criteria:\n\n* Patients diagnosed with Bell's palsy according to \"Clinical Practice Guideline: Bell's Palsy\" published by AAO-HNS in 2013;\n* First onset of Bell's palsy with only one side affected;\n* On the 10th day after the onset of palsy, HBGS score ranging from grade IV to VI;\n* According to the latest Chinese Guidelines for Bell's Palsy, within 72 hours of symptom onset for Bell's Palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day;\n* Adults aged 18 years of age or older (no limitation on gender).\n\nExclusion Criteria:\n\n* Facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, Hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis;\n* Fear of intradermal acupuncture;\n* allergy to adhesive tape;\n* Severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system;\n* Cognitive impairment, mental illness, contagious disease, pregnant and lactating;\n* Previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.","ALL","18 Years",{"count":94,"type":95},552,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study aims to assess the effect of intradermal acupuncture(IA) and guided self-rehabilitation management program(GRMP) (either single or combined) for patients with severe Bell's Palsy.",[101],"Bell Palsy",[101,103,104],"Intradermal acupuncture","Self-rehabilitation","2025-04-27",{"date":107,"type":108},"2025-04-30","ACTUAL",{"date":110,"type":108},"2025-03-24",{"date":112,"type":95},"2029-12-31",{"name":5,"class":6},1]