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Effects of Ocular Electroacupuncture on Abducens Nerve Palsy

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ClinicalTrials.gov Identifier: NCT03099460
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease Intervention/treatment Phase
Abducens Nerve Paralysis Other: ocular electroacupuncture Other: ocular acupuncture Other: sham acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Ocular Electroacupuncture for Abducens Nerve Palsy
Estimated Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

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.




Primary Outcome Measures :
  1. Change from Baseline in Ocular Motility Rating Score at 6 Weeks [ Time Frame: 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 Outcome Measures :
  1. 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.

  2. Eyeball movement distance [ Time Frame: 6 week ]
    The distances of eyeball movement in outward direction will be measured. The differences between affected and healthy eye will be calculated.

  3. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099460


Contacts
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Contact: LingYun Zhou, PhD +86 13351113936 no1zhly@163.com
Contact: TieJuan Liu, PhD +86 13946062207 ltj850722@126.com

Locations
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China, Heilongjiang
The first affiliated hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Lingyun Zhou, PhD    +86 13351113936    no1zhly@163.com   
Contact: Tiejuan Liu, PhD    +86 13946062207    ltj850722@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Study Chair: Lingyun Zhou, PhD First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03099460     History of Changes
Other Study ID Numbers: 2017031601
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Harbin Medical University:
electroacupuncture
abducens nerve palsy
eyeball movement
diplopia
ocular motility disorder
Additional relevant MeSH terms:
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Paralysis
Abducens Nerve Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cranial Nerve Diseases