Back to resultsEffects of Ocular Electroacupuncture on Abducens Nerve Palsy
Primary Purpose
Abducens Nerve Paralysis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ocular electroacupuncture
ocular acupuncture
sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Abducens Nerve Paralysis focused on measuring electroacupuncture, abducens nerve palsy, eyeball movement, diplopia, ocular motility disorder
Eligibility Criteria
Criteria: Inclusion criteria;
- patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;
- patient in stable condition after treatment for primary disease;
- age between 18 to 80 years old without gender limitation;
- haven't received acupuncture intervention for ANP before;
- patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.
Exclusion criteria:
- 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;
- those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
- those with serious medical conditions that might limit their participation;
- those with eye or other location with serious infections;
- women who had a positive pregnancy test or who were planning to become pregnant during the study period;
- those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
- who had participate in other clinical trials, which may affect the results.
Sites / Locations
- The first affiliated hospital of Harbin Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
ocular electroacupuncture
ocular acupuncture
sham acupuncture
Arm 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 abducens nerve.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Eyeball movement distance
The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.
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.
Full Information
NCT ID
NCT03099460
First Posted
March 24, 2017
Last Updated
March 28, 2017
Sponsor
First Affiliated Hospital of Harbin Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03099460
Brief Title
Effects of Ocular Electroacupuncture on Abducens Nerve Palsy
Official Title
A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 6, 2017 (Anticipated)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Harbin Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abducens Nerve Paralysis
Keywords
electroacupuncture, abducens nerve palsy, eyeball movement, diplopia, ocular motility disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ocular electroacupuncture
Arm Type
Experimental
Arm 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 abducens nerve.
Arm Title
ocular acupuncture
Arm Type
Experimental
Arm 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 abducens nerve.
Arm Title
sham acupuncture
Arm Type
Sham Comparator
Arm 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 abducens nerve. When the care provider performed operating acupuncture, the needles of sham acupuncture set will not be inserted into the skin of patient.
Intervention Type
Other
Intervention Name(s)
ocular electroacupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ocular acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Ocular Motility Rating Score at 6 Weeks
Description
The patient will receive grading of eyeball outward moving ability by investigator. The changes of rating score from baseline will be recorded.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Angle of diplopia deviation
Description
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically.
Time Frame
6 week
Title
Eyeball movement distance
Description
The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.
Time Frame
6 week
Title
The quality of life questionnaire for ocular motor nerve palsy
Description
The patients will finish a questionnaire to evaluate their physical and psychological status during this trial.
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria: Inclusion criteria;
patient with confirmed diagnosis of abducens nerve palsy made by neurologist or ophthalmologist;
patient in stable condition after treatment for primary disease;
age between 18 to 80 years old without gender limitation;
haven't received acupuncture intervention for ANP before;
patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.
Exclusion criteria:
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;
those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
those with serious medical conditions that might limit their participation;
those with eye or other location with serious infections;
women who had a positive pregnancy test or who were planning to become pregnant during the study period;
those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
who had participate in other clinical trials, which may affect the results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LingYun Zhou, PhD
Phone
+86 13351113936
Email
no1zhly@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
TieJuan Liu, PhD
Phone
+86 13946062207
Email
ltj850722@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingyun Zhou, PhD
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingyun Zhou, PhD
Phone
+86 13351113936
Email
no1zhly@163.com
First Name & Middle Initial & Last Name & Degree
Tiejuan Liu, PhD
Phone
+86 13946062207
Email
ltj850722@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Ocular Electroacupuncture on Abducens Nerve Palsy
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