Efficacy of intraorbital electroacupuncture for diabetic abducens nerve palsy： study protocol for a prospective single-center randomized controlled trial

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.