针灸作为青光眼的辅助疗法:随机对照试验方案》。

IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES JMIR Research Protocols Pub Date : 2024-10-08 DOI:10.2196/57888
Yi-Fang Liao, Yu-Chen Lee, Hui-Ju Lin, Yi-Ching Shao
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引用次数: 0

摘要

背景:青光眼是一种慢性进行性视神经病变,需要终生治疗以减少视神经的衰退。由于患者需要长期持续接受治疗,辅助疗法往往与传统疗法并用,以提高治疗效果。在以往的临床试验中,针灸已被证明具有降低眼压的潜力,是一种很有前景的青光眼干预方法:本研究的主要目的是对青光眼患者进行单中心随机对照试验。针灸将作为一种辅助疗法进行评估。试验旨在探讨针灸对青光眼的疗效:在这项单中心随机对照试验中,患有原发性开角型青光眼的参与者(N=50)将被随机分配到治疗组(接受具有 "得气 "感觉的眼部针灸)或对照组(接受非眼部穴位的最低针灸刺激)。干预措施包括每周一次的针灸治疗,共 6 次。参与者将在 8 个时间点接受评估,分别是基线、干预期间(6 次)和 3 个月的随访。主要结果是每次针灸治疗前后眼压的变化。次要结果包括针灸前后的心率和血压测量、最佳矫正视力、视野、光学相干断层扫描、光学相干断层血管造影、青光眼症状量表和青光眼生活质量-15问卷:试验于 2023 年 6 月 28 日开始招募参与者。共招募了 10 名参与者,以测试试验的可行性。我们预计该试验的初步数据将于 2025 年 12 月完成:本试验采用严格的方法和全面的结果测量来评估针灸作为青光眼辅助疗法的临床疗效,为未来的临床治疗指南提供有价值的见解:试验注册:ClinicalTrials.gov NCT05753137;https://clinicaltrials.gov/study/NCT05753137.International 注册报告标识符 (irrid):DERR1-10.2196/57888。
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Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial.

Background: Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline of the optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often considered alongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential to lower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention.

Objective: The primary objective of this study is to conduct a single-center randomized control trial involving patients with glaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma.

Methods: In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will be randomly assigned to the treatment group, receiving ophthalmic acupuncture with "De Qi" sensation, or the control group, receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncture treatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6 times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after each acupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture, best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the Glaucoma Symptom Scale, and the Glaucoma Quality of Life-15 questionnaire.

Results: Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December 2025.

Conclusions: This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines.

Trial registration: ClinicalTrials.gov NCT05753137; https://clinicaltrials.gov/study/NCT05753137.

International registered report identifier (irrid): DERR1-10.2196/57888.

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