Abducens Nerve Paralysis
Conditions
Keywords
electroacupuncture, abducens nerve palsy, eyeball movement, diplopia, ocular motility disorder
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.
Interventions
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.
OTHERocular 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.
OTHERsham 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.
Sponsors
First Affiliated Hospital of Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Ocular Motility Rating Score at 6 Weeks | 6 week | The patient will receive grading of eyeball outward moving ability by investigator. The changes of rating score from baseline will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angle of diplopia deviation | 6 week | Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. |
| Eyeball movement distance | 6 week | 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 | 6 week | The patients will finish a questionnaire to evaluate their physical and psychological status during this trial. |
Countries
China
Contacts
Primary ContactLingYun Zhou, PhD
Backup ContactTieJuan Liu, PhD
Outcome results
None listed