Effects of Ocular Electroacupuncture on Oculomotor Nerve Palsy

Harbin Medical University

Status: Unknown

Conditions: Oculomotor Nerve Palsy

Treatments: Other: sham acupuncture; Other: ocular acupuncture; Other: ocular electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03099447

2017030801

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria;

1. patient with confirmed diagnosis of complete oculomotor nerve palsy (with or without mydriasis) 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 ONP 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 ONP 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 3 patient groups

ocular electroacupuncture

Experimental group

Description:

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.

Treatment:

Other: ocular electroacupuncture

ocular acupuncture

Experimental group

Description:

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.

Treatment:

Other: ocular acupuncture

sham acupuncture

Sham Comparator group

Description:

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.

Treatment:

Other: sham acupuncture