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Clinical Evaluation of Acupuncture in Treating Glaucoma

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ClinicalTrials.gov Identifier: NCT04157530
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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

Condition or disease Intervention/treatment Phase
Glaucoma Acupuncture Device: wang-bu-liu-xing Device: acupuncture Device: Electroacupuncture Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Acupuncture in Treating Glaucoma
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Glaucoma

Arm Intervention/treatment
Sham Comparator: sham group
15 subjects with seeds of wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
Device: wang-bu-liu-xing
wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
Other Name: Canon Pneumotonometer

Experimental: acupuncture group
15 subjects with acupuncture applied to Qingming and Qiuhou with Der-qi
Device: acupuncture
acupuncture applied to Qingming and Qiuhou with Der-qi

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




Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: 20 min, twice/week for 2 weeks ]
    Primary outcome measure was the changes of intraocular pressure,



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04157530


Locations
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Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Ching-Liang Hsieh, PhD China Medical University, China

Publications of Results:
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04157530     History of Changes
Other Study ID Numbers: CMUH106-REC2-161
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
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
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases