Effects of Acupuncture on Sjögren's Syndrome

Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial

Sponsoren

Hauptsponsor: Ana Carolina Fragoso Motta, DDS, PhD

Quelle University of Sao Paulo
Kurze Zusammenfassung

Sjögren's syndrome (SS) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. Xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. Although some drugs may improve symptoms and prevent SS complications, they can cause significant adverse effects and even fail to relieve symptoms. Integrative and complementary techniques have become a therapeutic option for SS patients. Scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. Due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for SS patients' symptoms relief.

detaillierte Beschreibung

The present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). The research will be conducted following the CONSORT recommendations and the STRICTA extension. The study care protocol will consist in acupuncture or control intervention at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) for 8 weeks, 20 minutes sessions with 12 weeks of follow up. Complementary clinical approaches (sialometry, sialochemistry, Schirmer test, staining with topical lissamine green), and the questionnaires (OHIP-14, Eular Sjögren's Syndrome Patient Reported Index (ESSPRI), Xerostomia Inventory, ocular surface disease index (OSDI) will be performed in weeks 1, 8 and 12. The control group will consist of superficial acupuncture, or placebo, or sham. After all interventions and evaluation methods completed, data will be analyzed for their distribution and homogeneity in order to choose the most appropriate statistical test.

Gesamtstatus Enrolling by invitation
Anfangsdatum February 18, 2019
Fertigstellungstermin December 2020
Primäres Abschlussdatum December 2020
Phase N/A
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Xerostomia Inventory score at at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline The Challacombe scale at at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Ocular Surface Disease Index (OSDI) at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Sekundäres Ergebnis
Messen Zeitfenster
Changes from baseline whole unstimulated salivary flow rate at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Schirmer test scores at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline ocular surface staining at 2 and 3 months. Before (baseline), immediately after and 1 month after acupuncture treatment.
Einschreibung 50
Bedingung
Intervention

Interventionsart: Other

Interventionsname: Acupuncture

Beschreibung: Acupuncture stimulation was done manually, using single-use acupuncture needles that will be inserted on the selected acupoints (R6, E6, E2, Ig4, VC24, TA23, B2) once a week,for 8 weeks, 20 minutes sessions with 12 weeks of follow up.

Armgruppenetikett: acupuncture

Interventionsart: Other

Interventionsname: Sham acupuncture

Beschreibung: The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Armgruppenetikett: Sham acupuncture

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Adults ≥ 18 years old, both genres, who consent to participate of the study

- Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism

Exclusion Criteria:

- Patients who have undergone head and neck radiation therapy;

- Patients with a history of neoplasias and salivary gland infections;

- Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;

- Patients with inability to undergo total saliva collection by established techniques;

- Patients who can not attend regular acupuncture sessions;

- Patients who had a change in the dosage of medications in use within 6 weeks before the start of the study.

- Patients who received acupuncture therapy up to 6 weeks prior to the start of the study.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Ort
Einrichtung: School of Dentistry of Ribeirão Preto, University of São Paulo
Standort Länder

Brazil

Überprüfungsdatum

March 2020

Verantwortliche Partei

Art: Sponsor-Investigator

Ermittlerzugehörigkeit: University of Sao Paulo

Vollständiger Name des Ermittlers: Ana Carolina Fragoso Motta, DDS, PhD

Ermittlertitel: Professor of Oral Diagnosis

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: acupuncture

Art: Experimental

Beschreibung: Acupuncture at the selected points.

Etikette: Sham acupuncture

Art: Sham Comparator

Beschreibung: Similar appearance to conventional acupuncture, however, without needles skin penetration.

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Beschreibung des Interventionsmodells: Sjogren syndrome's patients will be randomly assigned to either acupuncture (experimental group) at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) or sham acupuncture (control group), where the needles do not penetrate the skin into non acupuncture points, for 8 weeks, 20 minutes sessions with 12 weeks of follow up.

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Maskierungsbeschreibung: Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.

Quelle: ClinicalTrials.gov