Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of "Holistic Health Care."
详细描述
Method: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of "Holistic Health Care."
Expected Results:
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.
- Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.
- Evaluate the therapeutic differences between the SJS-DES and Non-SJS-DES populations.
Keywords: Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, GB20, BL2, LI4, LI11
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization process will be conducted by a statistical expert using permuted block randomization to generate a "Clinical Trial Randomized Allocation Table." The allocation details will be sealed in envelopes to ensure blinding. Additionally, individual decoding envelopes will be prepared for each participant to allow emergency unblinding without compromising the trial's integrity. The randomization table and grouping details will be securely stored by the statistical expert and the principal investigator, while the individual decoding envelopes will be kept exclusively by the principal investigator.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dry eye syndrome
- •Inclusion Criteria:
- •aged between 20 and 75 years
- •Schirmer's test less than 10 mm/5 min
排除标准
- •With eye inflammation or infectious eye disease
- •Accepted operation of eye
- •Sjögren's syndrome
- •Inclusion Criteria:
- •primary or secondary SS
- •aged between 20 and 75 years
- •fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
- •had no abnormal findings of immune, liver, kidney, or blood function evaluations.
- •Exclusion Criteria:
- •a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- •pregnancy or breastfeeding
- •steroid pulse therapy within three months prior to the commencement of our study.
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: one year
Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
Schirmer's test
时间窗: one year
Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
Ocular Surface Disease Index (OSDI)
时间窗: one year
Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).
次要结局
- EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)(one year)
- Traditional Chinese Medicine (TCM) tongue diagnosis(one year)
- Traditional Chinese Medicine (TCM) pulse diagnosis(one year)
- Traditional Chinese Medicine (TCM) constitution questionnaire(one year)
- Traditional Chinese Medicine (TCM) heart rate variability analysis(one year)
- Nailfold microcirculation assessment(one year)
- Iris examination(one year)
研究者
Ching-Mao Chang
Director of Division of Integrative Medicine, Center for Traditional Medicine
Taipei Veterans General Hospital, Taiwan