Acupuncture for Primary Sjögren Syndrome

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Device: acupuncture group
* Device: Sham Acupuncture group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>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. | Device: acupuncture group<br>* 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.<br>|
| Sham Comparator: Sham Acupuncture group<br>Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm. | Device: Sham Acupuncture group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Subjects will be asked to provide every NAS score based on the average situation over the past 24 hours 13 rather than a point of time. And we will collect NAS scores three times a week in week0-8 (24 times in total) as removal of a variety of factors causing bias, including mental relaxation in weekend, weather changing, or unexpected events life in, etc., each of which may influence the feelings of dryness, fatigue, and pain. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NAS of each item including dryness, fatigue, and pain. | Subjects will be asked to provide every NAS score based on the average situation over the past 24 hours 13 rather than a point of time. And we will collect NAS scores three times a week in week0-8 (24 times in total) as removal of a variety of factors causing bias, including mental relaxation in weekend, weather changing, or unexpected events life in, etc., each of which may influence the feelings of dryness, fatigue, and pain. | 24 weeks | 
| Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) | it will be measured at week0/8/16/24 | 24 weeks | 
| Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36) | it will be measured at week0/8/16/24 | 24 weeks | 
| Change in Hospital Anxiety and Depression (HAD) scale score | it will be measured at week0/8/16/24 | 24 weeks | 
| Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels | it will be measured at week0/24 | 24 weeks | 
| Change in image of Salivary glands measured by ultrasound | it will be measured at week0/24 | 24 weeks | 
| Change in Schirmer test score and unstimulated salivary flow | it will be measured at week0/8/16/24 | 24 weeks | 
| Adverse events | it will be measured at week0/8/16/24, and be observed, documented, and evaluated in detail. | 24 weeks |