Previously submitted to: JMIR Research Protocols (no longer under consideration since Dec 10, 2024)
Date Submitted: Apr 27, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration: Protocol for a Randomized Controlled Trial
ABSTRACT
Introduction: Age-related macular degeneration (AMD), including dry-AMD and wet-AMD, is a common cause of blindness in the elderly population (above 60). However, there has not been effective treatment for dry-AMD so far. Traditional Chinese Medicine (TCM) acupuncture, practiced for over 2500 years in China, has gained popularity in Western countries as a complementary therapy. Also, a meta-analysis conducted by our team in 2023 shows that acupuncture is significantly more effective than interventions of the control groups, and that the most frequently selected acupuncture points in the literature, excluding those with incomplete data, were Jingming (BL01) and Zanzhu (BL02). As traditional needle acupuncture is invasive, lowering patients’ willingness to undergo the treatment, Jingming (BL01) is contraindicated for laser acupuncture to prevent eye injury due to its location, we suggest further investigation into the efficacy of laser acupuncture on Zanzhu (BL02). / Methods and analysis: This study is a single-center, investigator-initiated, assessor-blinded, parallel randomized controlled trial. 30 participants would be enrolled. This study consists of 15 visits, which are divided into 1 screening visit, 12 treatment visits, and 2 survey visits in chronological order. Over the 12 treatment visits in 4 weeks, both groups would receive interventions three times a week. Laser acupuncture with the wave of 808nm and the output power of 100mw would be performed on bilateral BL02 for 3 min. On the other hand, the control group would receive sham laser acupuncture with the wave of 0nm and the output power of 0mw on the same acupoints for 3 min. The frequency of interventions would be recorded during the trial. The primary outcomes are Best Corrected Visual Acuity (BCVA). The outcomes would be mostly assessed at visits 1, 13 and 14. All data would be analyzed with SPSS Statistics V.21 after completely collected. / Ethics and dissemination: This study was approved by the institutional review board of China Medical University Hospital (Approval No. CMUH112-REC2-141). The obtained results would be disseminated through publication in a peer-reviewed journal. / Trial registration number: NCT06264947
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