Clinical Evaluation of Acupuncture in Treating Glaucoma

NCT ID: NCT04157530

Last Updated: 2019-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-11-01

Brief Summary

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The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.

Detailed Description

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Glaucoma is a syndrome, and that is results from intraocular pressure increases cause visual field narrow and blindness. The incidence of adult blindness induced by glaucoma is second in the ophthalmologic disease in the world. Many studies report that both blood circulation in the eye surroundings and intraocular pressure increase play an important role in glaucoma. Several studies show that acupuncture can modulate intraocular pressure and improve activity of central visual acuity and also increase blood flow of eye fundus. Jingming (BL1) can communicate yi and yang, and nourish and clear eyes, Qiuhou (EX-HN7) can transport qi and activate blood, and freely flowing meridian and clear eyes. Therefore, the purpose of the present study was to investigate the therapeutic effect of acupuncture at Jinming and Qiuhou on intraocular pressure in patients with glaucoma. The study designed as a single-blinded, randomized, controlled clinical trial, a total of45 patients with glaucoma divided into three groups, each group was15 subjects as follows: 1) sham group, using the seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints, one times/day, and each time was 20 min, twice/week for 2 weeks; 2) acupuncture group, the methods were identical to the sham group, but used acupuncture applied to Qingming and Qiuhou with Der-qi; 3) Electroacupuncture group, the methods were identical to acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch. Primary outcome measure was the changes of intraocular pressure, and the second outcome measure was the score changes of WHOQOL-REF (Taiwan version).

The present study predicts that acupuncture or electroacupuncture can reduce intraocular pressure and also can improve quality of life in patients with glaucoma.

Conditions

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Glaucoma Acupuncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sham group

15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

Group Type SHAM_COMPARATOR

wang-bu-liu-xing

Intervention Type DEVICE

wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

acupuncture group

15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

acupuncture applied to Qingming and Qiuhou with Der-qi

Electroacupuncture group

15 subjects wth acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type DEVICE

acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch

Interventions

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wang-bu-liu-xing

wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints

Intervention Type DEVICE

acupuncture

acupuncture applied to Qingming and Qiuhou with Der-qi

Intervention Type DEVICE

Electroacupuncture

acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch

Intervention Type DEVICE

Other Intervention Names

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Canon Pneumotonometer

Eligibility Criteria

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Inclusion Criteria

1. Glaucoma for at least three months
2. Do not use ocular hypotensive drugs or use only one ocular hypotensive drug.
3. It is over 20 years old.
4. Men and women are informal.
5. There is no evidence other than glaucoma that shows other eye diseases.
6. Be aware and fill out the consent form yourself.

Exclusion Criteria

1. Combines other chronic diseases, taking multiple medications such as high blood pressure, diabetes, etc.
2. Those who have had glaucoma surgery.
3. Those who had undergone myopia laser surgery.
4. Can not accept acupuncture points stimulators.
5. Allergic to acupuncture needles.
6. Has a mental illness or is unable to cooperate with the researcher.
7. Do not sign consent
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Liang Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

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China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Mac Nair CE, Nickells RW. Neuroinflammation in Glaucoma and Optic Nerve Damage. Prog Mol Biol Transl Sci. 2015;134:343-63. doi: 10.1016/bs.pmbts.2015.06.010. Epub 2015 Jul 10.

Reference Type RESULT
PMID: 26310164 (View on PubMed)

Chen SY, Yieh FS, Liao WL, Li TC, Hsieh CL. Effect of Acupuncture on Intraocular Pressure in Glaucoma Patients: A Single-Blinded, Randomized, Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 28;2020:7208081. doi: 10.1155/2020/7208081. eCollection 2020.

Reference Type DERIVED
PMID: 32419820 (View on PubMed)

Other Identifiers

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CMUH106-REC2-161

Identifier Type: -

Identifier Source: org_study_id

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