Effects of Ocular Electroacupuncture on Oculomotor Nerve Palsy

Not Applicable

• Conditions: Oculomotor Nerve Palsy
• Interventions: Other: ocular acupuncture; Other: sham acupuncture; Other: ocular electroacupuncture

• Registration Number: NCT03099447
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

The purpose of the study is to testify the efficacy of treating oculomotor nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

Detailed Description

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for oculomotor nerve palsy (ONP), through treating ONP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by oculomotor nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-28
• Last Update Submitted: 2017-03-28
• Study First Posted: 2017-04-04
• Last Update Posted: 2017-04-04
• Study Start: 2017-04-06
• Primary Completion: 2019-03-25
• Study Completion: 2019-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ocular acupuncture	ocular acupuncture	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 oculomotor nerve.
sham acupuncture	sham 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 oculomotor nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient.
ocular electroacupuncture	ocular electroacupuncture	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 oculomotor nerve.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Ocular motor nerve function subscale at 6 Weeks	6 week	The patient will receive grading of eyelid lifting, eyeball inward, upward and downward moving ability by investigator. A total score will be summed up.The changes from baseline will be recorded.

Secondary Outcome Measures

Name	Time	Method
The quality of life questionnaire for ocular motor nerve palsy	6 week	The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.
Angle of diplopia deviation	6 week	Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.
Eyeball movement distance	6 week	The distances of eyeball movement in inward, upward and downward direction and height between eyelids will be measured. The differences between affected and healthy eye will be calculated.

Trial Locations

Locations (1)

The first affiliated hospital of Harbin Medical University; 🇨🇳 Harbin Shi, Heilongjiang, China