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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocular electroacupuncture | Experimental | 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. |
|
| ocular acupuncture | Experimental | 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. |
|
| sham acupuncture | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocular electroacupuncture | Other | 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. |
| 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 |
| 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 |
| Eyeball movement distance |
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Criteria: Inclusion criteria;
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LingYun Zhou, PhD | Contact | +86 13351113936 | no1zhly@163.com | |
| TieJuan Liu, PhD | Contact | +86 13946062207 | ltj850722@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingyun Zhou, PhD | First Affiliated Hospital of Harbin Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150001 | China |
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| ID | Term |
|---|---|
| D020434 | Abducens Nerve Diseases |
| D004172 | Diplopia |
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
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|
| ocular acupuncture | Other | 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 acupuncture | Other | 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. |
|
The distances of eyeball movement in outward direction 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 | The patients will finish a questionnaire to evaluate their physical and psychological status during this trial. | 6 week |
| D009461 |
| Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |