Abducens nerve palsy（ANP） is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its effica...Abducens nerve palsy（ANP） is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its efficacy in randomized controlled trials remains unclear. Herein, we designed a protocol for a prospective, single-center, randomized controlled trial to investigate the effect of intraorbital electroacupuncture on diabetic ANP. We plan to recruit 60 patients with diabetic ANP, and randomly divide them into treatment and control groups. Patients in both groups will continue their glucose-lowering therapy. A neural nutrition drug will be given to both groups for six weeks. The treatment group will also receive intraorbital electroacupuncture therapy. We will assess efficacy of treatment, eyeball movement, diplopia deviation and the levels of fasting blood-glucose and glycosylated hemoglobin before treatment at 2, 4, and 6 weeks after treatment. The efficacy and recurrence will be investigated during follow-up（1 month after intervention）. This protocol was registered at Chinese Clinical Trial Registry on 16 January 2015（Chi CTR-IPR-15005836）. This study was approved by the Ethics Committee of First Affiliated Hospital of Harbin Medical University of China（approval number： 201452）. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. We envisage that the results of this clinical trial will provide evidence for promoting clinical use of this new therapy for management of ANP.展开更多
Diabetic abducens nerve palsy main symptoms include ocular motility disorders and diplopia.This disease is mainly caused by severe vascular degeneration.It is a serious impact on patient＇s quality of life and mental ...Diabetic abducens nerve palsy main symptoms include ocular motility disorders and diplopia.This disease is mainly caused by severe vascular degeneration.It is a serious impact on patient＇s quality of life and mental health.Currently,there is no effective means of intervention for eye movement disorders and diplopia,the patients could only expect for neural self-repair.[1] Our team invented intraorbital electroacupuncture （IEA） therapy to repair abducens nerve affected by diabetes.In the meantime,we applied it into clinical practice and achieved great success.展开更多
基金supported by the National Natural Science Foundation of China,No.81674052the Key Project of Natural Science Foundation of Heilongjiang Province of China,No.ZD201211a grant from the Project of Innovational Scientific Research of Harbin Medical University of China,No.2016LCZX49
文摘Abducens nerve palsy（ANP） is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its efficacy in randomized controlled trials remains unclear. Herein, we designed a protocol for a prospective, single-center, randomized controlled trial to investigate the effect of intraorbital electroacupuncture on diabetic ANP. We plan to recruit 60 patients with diabetic ANP, and randomly divide them into treatment and control groups. Patients in both groups will continue their glucose-lowering therapy. A neural nutrition drug will be given to both groups for six weeks. The treatment group will also receive intraorbital electroacupuncture therapy. We will assess efficacy of treatment, eyeball movement, diplopia deviation and the levels of fasting blood-glucose and glycosylated hemoglobin before treatment at 2, 4, and 6 weeks after treatment. The efficacy and recurrence will be investigated during follow-up（1 month after intervention）. This protocol was registered at Chinese Clinical Trial Registry on 16 January 2015（Chi CTR-IPR-15005836）. This study was approved by the Ethics Committee of First Affiliated Hospital of Harbin Medical University of China（approval number： 201452）. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. We envisage that the results of this clinical trial will provide evidence for promoting clinical use of this new therapy for management of ANP.
基金This work was supported by a grant from the National Natural Science Foundation of China （No. 81674052）.
文摘Diabetic abducens nerve palsy main symptoms include ocular motility disorders and diplopia.This disease is mainly caused by severe vascular degeneration.It is a serious impact on patient＇s quality of life and mental health.Currently,there is no effective means of intervention for eye movement disorders and diplopia,the patients could only expect for neural self-repair.[1] Our team invented intraorbital electroacupuncture （IEA） therapy to repair abducens nerve affected by diabetes.In the meantime,we applied it into clinical practice and achieved great success.
