Dry Eye Syndrome (DES), Laser Acupuncture, Sjögren's Syndrome (SS)
Conditions
Keywords
Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), Quchi (LI11)
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
Interventions
The RJ-Laser acupuncture device (Reimers & Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.
DIAGNOSTIC_TESTNumerical Rating Scale (NRS)
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Numerical Rating Scale (NRS).
DIAGNOSTIC_TESTSchirmer's test
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Schirmer's test.
DIAGNOSTIC_TESTOcular Surface Disease Index (OSDI)
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the OSDI test.
DIAGNOSTIC_TESTEULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the ESSPRI.
DIAGNOSTIC_TESTTraditional Chinese Medicine (TCM) tongue diagnosis
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) tongue diagnosis.
DIAGNOSTIC_TESTTraditional Chinese Medicine (TCM) pulse diagnosis
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) pulse diagnosis.
DIAGNOSTIC_TESTTraditional Chinese Medicine (TCM) constitution questionnaire
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) constitution questionnaire.
DIAGNOSTIC_TESTTraditional Chinese Medicine (TCM) heart rate variability analysis
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) heart rate variability analysis.
DIAGNOSTIC_TESTnailfold microcirculation assessment
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the nailfold microcirculation assessment.
DIAGNOSTIC_TESTiris examination
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the iris examination.
OTHERSham Laser Acupuncture
The RJ-Laser acupuncture device (Reimers & Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds. The sham laser acupuncture procedure follows the same process as the true laser acupuncture protocol, including the positioning, cleaning of acupoints, and wearing of protective goggles. However, no laser emission is delivered during the treatment. This ensures a consistent experience for the patient while maintaining the blinding integrity of the study.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) | one year | Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES). |
| Schirmer's test | one year | Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES). |
| Ocular Surface Disease Index (OSDI) | one year | Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese Medicine (TCM) pulse diagnosis | one year | Traditional Chinese Medicine (TCM) pulse diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES). |
| Traditional Chinese Medicine (TCM) constitution questionnaire | one year | Traditional Chinese Medicine (TCM) constitution questionnaire is a tool for detecting the constitution among the Dry eye syndrome (DES). |
| Iris examination | one year | Iris examination is a tool for detecting the status of iris among the Dry eye syndrome (DES). |
| Nailfold microcirculation assessment | one year | Nailfold microcirculation assessment is a tool for detecting the status of nailfold microcirculation among the Dry eye syndrome (DES). |
| Traditional Chinese Medicine (TCM) heart rate variability analysis | one year | Traditional Chinese Medicine (TCM) heart rate variability analysis is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES). |
| EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) | one year | EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a tool for evaluating the symptoms of SJS among the Dry eye syndrome (DES). |
| Traditional Chinese Medicine (TCM) tongue diagnosis | one year | Traditional Chinese Medicine (TCM) tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES). |
Countries
Taiwan
Contacts
Primary ContactChing-Mao Chang, M.D., Ph.D.
Outcome results
None listed