An interventional study of ocular electroacupuncture and ocular acupuncture in Trochlear Nerve Palsy, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by First Affiliated Hospital of Harbin Medical University · Not applicable, Interventional, and Treatment
The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.
The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's planned enrollment of 144 is above the median of 30 across 537 interventional studies indexed under Paralysis.
Browse Paralysis studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.
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Exclusion criteria:
Patients will receive electroacupuncture for 40 mins with certain parameter at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve.
Other: ocular electroacupuncture
Patients will receive acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve.
Other: ocular acupuncture
Patients will receive sham acupuncture for 40 mins at ocular area, once daily, 5 times a week and 6 weeks in all. The acupoints are selected based on the anatomy of extraocular muscles innervated by trochlear nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient.
Other: sham acupuncture
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0\~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.
During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.
Change from Baseline in Angle of diplopia deviation at 6 Weeks
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. The changes from baseline will be recorded.
Time frame: 6 week
The quality of life questionnaire for ocular motor nerve palsy
The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.
Time frame: 6 week
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Harbin Medical University