摘要
Abducensnervepalsy(ANP)iscommonlyseeninpatientswithdiabetesmellitus.ThevalidityofacupunctureasatraditionalChinesemedicinemethodinperipheralnerverepairiswellestablished.However,itsefficacyinrandomizedcontrolledtrialsremainsunclear.Herein,wedesignedaprotocolforaprospective,single-center,randomizedcontrolledtrialtoinvestigatetheeffectofintraorbitalelectroacupunctureondiabeticANP.Weplantorecruit60patientswithdiabeticANP,andrandomlydividethemintotreatmentandcontrolgroups.Patientsinbothgroupswillcontinuetheirglucose-loweringtherapy.Aneuralnutritiondrugwillbegiventobothgroupsforsixweeks.Thetreatmentgroupwillalsoreceiveintraorbitalelectroacupuncturetherapy.Wewillassessefficacyoftreatment,eyeballmovement,diplopiadeviationandthelevelsoffastingblood-glucoseandglycosylatedhemoglobinbeforetreatmentat2,4,and6weeksaftertreatment.Theefficacyandrecurrencewillbeinvestigatedduringfollow-up(1monthafterintervention).ThisprotocolwasregisteredatChineseClinicalTrialRegistryon16January2015(ChiCTR-IPR-15005836).ThisstudywasapprovedbytheEthicsCommitteeofFirstAffiliatedHospitalofHarbinMedicalUniversityofChina(approvalnumber:201452).AllprotocolswillbeinaccordancewithDeclarationofHelsinki,formulatedbytheWorldMedicalAssociation.Writteninformedconsentwillbeprovidedbyparticipants.WeenvisagethattheresultsofthisclinicaltrialwillprovideevidenceforpromotingclinicaluseofthisnewtherapyformanagementofANP.
出版日期
2017年05月15日（中国期刊网平台首次上网日期，不代表论文的发表时间）
