Clinical trial NCT03099460: Effects of Ocular Electroacupuncture on Abducens Nerve Palsy
Official title: A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abducens Nerve Paralysis
Keywords: electroacupuncture
abducens nerve palsy
eyeball movement
diplopia
ocular motility disorder
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to testify the efficacy of treating abducens 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 abducens nerve palsy (ANP), through treating ANP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by abducens nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility criteria: Criteria: Inclusion criteria;

1. patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;
2. patient in stable condition after treatment for primary disease;
3. age between 18 to 80 years old without gender limitation;
4. haven't received acupuncture intervention for ANP before;
5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to ANP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
3. those with serious medical conditions that might limit their participation;
4. those with eye or other location with serious infections;
5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;
6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
7. who had participate in other clinical trials, which may affect the results.

Primary outcomes:
measure: Change from Baseline in Ocular Motility Rating Score at 6 Weeks
timeFrame: 6 week
Secondary outcomes:
measure: Angle of diplopia deviation
timeFrame: 6 week
measure: Eyeball movement distance
timeFrame: 6 week
measure: The quality of life questionnaire for ocular motor nerve palsy
timeFrame: 6 week
Other outcomes:
Locations:
city: Harbin
country: China
facility: The first affiliated hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Lingyun Zhou, PhD
role: STUDY_CHAIR
References: