Study: NCT06780293

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laser acupuncture (LA)
Description: 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.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laser acupuncture (LA)
Description: 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.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Laser acupuncture (LA)
Description: 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.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Laser acupuncture (LA)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Numerical Rating Scale (NRS)
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Numerical Rating Scale (NRS)
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Numerical Rating Scale (NRS)
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Numerical Rating Scale (NRS)
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Numerical Rating Scale (NRS)
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Schirmer's test
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Schirmer's test
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Schirmer's test
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Schirmer's test
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Schirmer's test
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Ocular Surface Disease Index (OSDI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Ocular Surface Disease Index (OSDI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Ocular Surface Disease Index (OSDI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Ocular Surface Disease Index (OSDI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Ocular Surface Disease Index (OSDI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) tongue diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) tongue diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) tongue diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) tongue diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Traditional Chinese Medicine (TCM) tongue diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) pulse diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) pulse diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) pulse diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) pulse diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Traditional Chinese Medicine (TCM) pulse diagnosis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) constitution questionnaire
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) constitution questionnaire
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) constitution questionnaire
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) constitution questionnaire
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Traditional Chinese Medicine (TCM) constitution questionnaire
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) heart rate variability analysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Traditional Chinese Medicine (TCM) heart rate variability analysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) heart rate variability analysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: Traditional Chinese Medicine (TCM) heart rate variability analysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Traditional Chinese Medicine (TCM) heart rate variability analysis
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: nailfold microcirculation assessment
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: nailfold microcirculation assessment
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: nailfold microcirculation assessment
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: nailfold microcirculation assessment
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: nailfold microcirculation assessment
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: iris examination
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: iris examination
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: iris examination
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: SHAM_COMPARATOR
Intervention: iris examination
Description: 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.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: iris examination
Description: 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.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Sham Laser Acupuncture
Description: 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.

Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Sham Laser Acupuncture
Description: 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.