Effects of Ocular Electroacupuncture on Abducens Nerve Palsy

A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy

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.

Study Overview

• Status: Unknown
• Conditions: Abducens Nerve Paralysis
• Intervention / Treatment: Other: ocular electroacupuncture; Other: ocular acupuncture; Other: sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • The First Affiliated Hospital Of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

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 abducens nerve.	Other: ocular electroacupuncture; 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 abducens nerve.	Other: ocular 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 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 abducens 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 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 Motility Rating Score at 6 Weeks	The patient will receive grading of eyeball outward moving ability by investigator. The changes of rating score from baseline will be recorded.	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angle of diplopia deviation	Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.	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.	6 week
Eyeball movement distance	The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.	6 week

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 6, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 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

• Keywords: electroacupuncture; diplopia; ocular motility disorder; abducens nerve palsy; eyeball movement
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Paralysis; Abducens Nerve Diseases
• Other Study ID Numbers: 2017031601

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