Acupuncture for Primary Sjögren Syndrome

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Sjogren's Syndrome

Treatments: Device: Sham Acupuncture group; Device: acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT02691377

2015S320

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

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.

Treatment:

Device: acupuncture group

Sham Acupuncture group

Sham Comparator group

Description:

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

Treatment:

Device: Sham Acupuncture group