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
Objective and accurate assessment of the degree of ocular motor nerve palsy is helpful not only in the evaluation of prognosis, but also for the screening of treatment methods. However, there is currently no comprehen...Objective and accurate assessment of the degree of ocular motor nerve palsy is helpful not only in the evaluation of prognosis, but also for the screening of treatment methods. However, there is currently no comprehensive measure of its severity. In this study, we designed the Ocular Motor Nerve Palsy Scale and investigated its validity and reliability. Six experts were invited to grade and evaluate the scale. The study recruited 106 patients with a definite diagnosis of unilateral isolated ocular motor nerve palsy. Three physicians evaluated the patients using the scale. One of the three physicians evaluated the patients again after 24 hours. The content validity index（CVI） and factor analysis were used to analyze the scale＇s construct validity. The intraclass correlation coefficient and Cronbach＇s alpha were used to evaluate the inter-rater and test-retest reliability and the internal consistency. The CVI results（I-CVI = 1.0, S-CVI = 0.9, Pc = 0.016, K＊ = 1） indicated good content validity. Factor analysis extracted two common factors that accounted for 85.2% of the variance. Furthermore, the load value of each component was above 0.8, indicating good construct validity. The Ocular Motor Nerve Palsy Scale was found to be highly reliable, with an inter-rater reliability intraclass correlation coefficient of 0.965（P 0.01）, a test-retest reliability intraclass correlation coefficient of 0.976（P 0.01）, and Cronbach＇s alpha values of 0.63–0.70. In conclusion, the Ocular Motor Nerve Palsy Scale with good validity and reliability can be used to quantify the severity of ocular motor nerve palsy. This study was registered at Chinese Clinical Trial Registry（registration number： Chi CTR-OOC-17010702）.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supported by the National Natural Science Foundation of China,No.81674052
文摘Objective and accurate assessment of the degree of ocular motor nerve palsy is helpful not only in the evaluation of prognosis, but also for the screening of treatment methods. However, there is currently no comprehensive measure of its severity. In this study, we designed the Ocular Motor Nerve Palsy Scale and investigated its validity and reliability. Six experts were invited to grade and evaluate the scale. The study recruited 106 patients with a definite diagnosis of unilateral isolated ocular motor nerve palsy. Three physicians evaluated the patients using the scale. One of the three physicians evaluated the patients again after 24 hours. The content validity index（CVI） and factor analysis were used to analyze the scale＇s construct validity. The intraclass correlation coefficient and Cronbach＇s alpha were used to evaluate the inter-rater and test-retest reliability and the internal consistency. The CVI results（I-CVI = 1.0, S-CVI = 0.9, Pc = 0.016, K＊ = 1） indicated good content validity. Factor analysis extracted two common factors that accounted for 85.2% of the variance. Furthermore, the load value of each component was above 0.8, indicating good construct validity. The Ocular Motor Nerve Palsy Scale was found to be highly reliable, with an inter-rater reliability intraclass correlation coefficient of 0.965（P 0.01）, a test-retest reliability intraclass correlation coefficient of 0.976（P 0.01）, and Cronbach＇s alpha values of 0.63–0.70. In conclusion, the Ocular Motor Nerve Palsy Scale with good validity and reliability can be used to quantify the severity of ocular motor nerve palsy. This study was registered at Chinese Clinical Trial Registry（registration number： Chi CTR-OOC-17010702）.
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.
