Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)

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A vizsgálat olyan felnőtteket keres, akiknek száraz szemük van, Sjögren-szindrómával vagy anélkül. A szokásos ellátás mellé adott lézeres akupunktúrát vizsgálják.

Életkor

20 és 75 év között

Nem

Mindkét nem részt vehet.

A betegség stádiuma

Száraz szem szindróma (Schirmer-teszt kevesebb mint 10 mm/5 perc), vagy elsődleges vagy másodlagos Sjögren-szindróma, amely megfelel a 2002-es amerikai–európai konszenzuskritériumoknak.

Korábbi kezelés

Sjögren-szindrómás résztvevők nem kaphattak szteroid pulzusterápiát a vizsgálat előtti három hónapban.

Biomarker vagy leletérték

Száraz szem esetén Schirmer-teszt kevesebb mint 10 mm/5 perc. Sjögren-szindróma esetén nincs kóros immun-, máj-, vese- vagy vérfunkciós lelet.

A részvétel fő kizáró okai

• Terhesség
• Szemgyulladás vagy fertőző szembetegség
• Korábbi szemműtét
• Alkoholbetegség, cukorbetegség vagy súlyos, életveszélyes betegség a kórtörténetben (Sjögren-csoport)
• Szoptatás (Sjögren-csoport)

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

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• 20 és 75 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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."

A vizsgálat 5 csoportja

• LA+LA group of SJS-DESA vizsgált kezelés

  LA+LA group of SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose.

  Kezelés: Laser acupuncture (LA), 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, Traditional Chinese Medicine (TCM) pulse diagnosis, Traditional Chinese Medicine (TCM) constitution questionnaire, Traditional Chinese Medicine (TCM) heart rate variability analysis, nailfold microcirculation assessment és iris examination

• Sham+LA group of SJS-DESSzínlelt kezelés, összehasonlításként

  Sham+LA group of SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose.

  Kezelés: Laser acupuncture (LA), 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, Traditional Chinese Medicine (TCM) pulse diagnosis, Traditional Chinese Medicine (TCM) constitution questionnaire, Traditional Chinese Medicine (TCM) heart rate variability analysis, nailfold microcirculation assessment, iris examination és Sham Laser Acupuncture

• LA+LA group of Non-SJS-DESA vizsgált kezelés

  LA+LA group of Non-SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose.

  Kezelés: Laser acupuncture (LA), 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, Traditional Chinese Medicine (TCM) pulse diagnosis, Traditional Chinese Medicine (TCM) constitution questionnaire, Traditional Chinese Medicine (TCM) heart rate variability analysis, nailfold microcirculation assessment és iris examination

• Sham+LA group of Non-SJS-DESSzínlelt kezelés, összehasonlításként

  Sham+LA group of Non-SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use 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 for this purpose.

  Kezelés: Laser acupuncture (LA), 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, Traditional Chinese Medicine (TCM) pulse diagnosis, Traditional Chinese Medicine (TCM) constitution questionnaire, Traditional Chinese Medicine (TCM) heart rate variability analysis, nailfold microcirculation assessment, iris examination és Sham Laser Acupuncture

• Waiting listEgyéb csoport

  Group Waiting list will not receive any treatment at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use 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 for this purpose.

  Kezelés: 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, Traditional Chinese Medicine (TCM) pulse diagnosis, Traditional Chinese Medicine (TCM) constitution questionnaire, Traditional Chinese Medicine (TCM) heart rate variability analysis, nailfold microcirculation assessment és iris examination