Effects of Ocular Electroacupuncture on Abducens Nerve Palsy

NCT ID: NCT03099460

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-06
• Study Completion Date: 2019-12-30

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.

Conditions

Abducens Nerve Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ocular electroacupuncture

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

ocular acupuncture

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

sham acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lingyun Zhou, PhD

Role: STUDY_CHAIR

First Affiliated Hospital of Harbin Medical University

Locations

The first affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

LingYun Zhou, PhD

Role: CONTACT

no1zhly@163.com

+86 13351113936

TieJuan Liu, PhD

Role: CONTACT

ltj850722@126.com

+86 13946062207

Facility Contacts

Lingyun Zhou, PhD

Role: primary

no1zhly@163.com

+86 13351113936

Tiejuan Liu, PhD

Role: backup

ltj850722@126.com

+86 13946062207

Other Identifiers

2017031601

Identifier Type: -

Identifier Source: org_study_id