Clinical trial NCT06780293: Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
Official title: Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dry Eye Syndrome (DES)
Laser Acupuncture
Sjögren's Syndrome (SS)
Keywords: Dry eye syndrome
Sjögren's syndrome
Laser Acupuncture
Fengchi (GB20)
Zanzhu (BL2)
Hegu (LI4)
Quchi (LI11)
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2025-01-17
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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."

Detailed description: 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:

1. Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.
2. Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.
3. 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

Eligibility criteria: • Dry eye syndrome

Inclusion Criteria:

1. aged between 20 and 75 years
2. Schirmer's test less than 10 mm/5 min

Exclusion Criteria:

1. Pregnancy
2. With eye inflammation or infectious eye disease
3. Accepted operation of eye

   * Sjögren's syndrome

Inclusion Criteria:

1. primary or secondary SS
2. aged between 20 and 75 years
3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
4. had no abnormal findings of immune, liver, kidney, or blood function evaluations.

Exclusion Criteria:

1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
2. pregnancy or breastfeeding
3. steroid pulse therapy within three months prior to the commencement of our study.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: one year
measure: Schirmer's test
timeFrame: one year
measure: Ocular Surface Disease Index (OSDI)
timeFrame: one year
Secondary outcomes:
measure: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
timeFrame: one year
measure: Traditional Chinese Medicine (TCM) tongue diagnosis
timeFrame: one year
measure: Traditional Chinese Medicine (TCM) pulse diagnosis
timeFrame: one year
measure: Traditional Chinese Medicine (TCM) constitution questionnaire
timeFrame: one year
measure: Traditional Chinese Medicine (TCM) heart rate variability analysis
timeFrame: one year
measure: Nailfold microcirculation assessment
timeFrame: one year
measure: Iris examination
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ching-Mao Chang
Study officials:
References: