Acupuncture for Primary Sjögren Syndrome

Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome

Sponsoren

Hauptsponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Quelle Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Kurze Zusammenfassung

The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome.

detaillierte Beschreibung

This randomized, double-blinded, sham acupuncture controlled trial is aimed to assess the effectiveness and safety of acupuncture in the treatment of Primary Sjögren Syndrome.The eligible participants will be randomly allocated to receive acupuncture or sham acupuncture for 8 weeks.

Assuming a two-sided alpha of 0.05, power of 85%, and a 20% drop-out, a sample sized of 30 would be needed for each group. The statistical analysis will be based on the intention-to-treat principle. Continuous variables will be compared by Student t test or Mann-Whitney U test; categorical variables will be analyzed by chi-square test, Fisher's exact test or Kruskal-Wallis H test as appropriate. For comparison between two time points, paired t-test or Wilcoxon signed rank test will be used as appropriate. A statistically significant difference was set at P<0.05.

Gesamtstatus Unknown status
Anfangsdatum March 2016
Fertigstellungstermin March 2017
Primäres Abschlussdatum March 2017
Phase Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
The proportion of participants who has a 30% or greater reduction in 2 of 3 items,including the numeric analog scale (NAS) of dryness, fatigue, and pain. 24 weeks
Sekundäres Ergebnis
Messen Zeitfenster
Change in NAS of each item including dryness, fatigue, and pain. 24 weeks
Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) 24 weeks
Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36) 24 weeks
Change in Hospital Anxiety and Depression (HAD) scale score 24 weeks
Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels 24 weeks
Change in image of Salivary glands measured by ultrasound 24 weeks
Change in Schirmer test score and unstimulated salivary flow 24 weeks
Adverse events 24 weeks
Einschreibung 60
Bedingung
Intervention

Interventionsart: Device

Interventionsname: acupuncture group

Beschreibung: Acupoints include 11 on the head, two on the upper extremities, and two on the lower extremities. Before performing acupuncture, a small pad will be pasted on each acupoint. All the needles will insert the acupoints through these pads. Then, they will be twirled, lifted and thrust three times to elicit the Deqi sensation. Each session will last 30 minutes.

Armgruppenetikett: Acupuncture group

Interventionsart: Device

Interventionsname: Sham Acupuncture group

Beschreibung: The same acupoints with acupuncture group are selected.A placebo needle with a blunt tip will be used to perform sham acupuncture. They will only insert the pad and no skin penetration. The same procedure with acupuncture group will be performed.

Armgruppenetikett: Sham Acupuncture group

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.

- With the symptoms of primary Sjögren syndrome less than 5 years.

Exclusion Criteria:

- With an acupuncture contraindication (allergy to metals, skin lesions on relative acupoints, etc.)

- Taking or taken medicine for primary Sjögren syndrome within last 4 weeks before the enrollment.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 65 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Xinyao Zhou, MD Principal Investigator Guang'anmen Hospital
Gesamtkontakt

Nachname: Xinyao Zhou, MD

Telefon: +8610-88001030

Email: [email protected]

Ort
Einrichtung: Kontakt: Guang'anmen Hospital, China academy of Chinese Medical Sciences Xinyao Zhou, MD +8610-88001030 [email protected]
Standort Länder

China

Überprüfungsdatum

February 2016

Verantwortliche Partei

Art: Principal Investigator

Ermittlerzugehörigkeit: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Vollständiger Name des Ermittlers: Zhou Xinyao

Ermittlertitel: Attending Physician & Lecturer

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

Etikette: Acupuncture group

Art: Experimental

Beschreibung: Participants will receive acupuncture for 8 weeks. In particular, acupuncture will be performed three times a week in earlier 4 weeks and twice a week in later 4 weeks.

Etikette: Sham Acupuncture group

Art: Sham Comparator

Beschreibung: Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.

Patientendaten Undecided
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Triple (Participant, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov