Effects of Ocular Electroacupuncture on Oculomotor Nerve Palsy

A Randomized Trial of Ocular Electroacupuncture for Oculomotor Nerve Palsy

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Heilongjiang
      • Harbin Shi, Heilongjiang, China, 150001
        • Recruiting
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Ocular motor nerve function subscale at 6 Weeks
Time Frame: 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.
6 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angle of diplopia deviation
Time Frame: 6 week
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.
6 week
Eyeball movement distance
Time Frame: 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.
6 week
The quality of life questionnaire for ocular motor nerve palsy
Time Frame: 6 week
The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 6, 2017

Primary Completion (Anticipated)

March 25, 2019

Study Completion (Anticipated)

July 25, 2019

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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