Acupuncture for Primary Sjögren Syndrome

Phase 2

• Conditions: Sjogren's Syndrome
• Interventions: Device: Sham Acupuncture group; Device: acupuncture group

• Registration Number: NCT02691377
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-20
• Study First Submitted QC: 2016-02-20
• Study First Posted: 2016-02-25
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29
• Study Start: 2016-03
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Acupuncture group	Sham Acupuncture group	Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.
Acupuncture group	acupuncture group	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression (HAD) scale score	24 weeks	it will be measured at week0/8/16/24
Change in Schirmer test score and unstimulated salivary flow	24 weeks	it will be measured at week0/8/16/24
Change in NAS of each item including dryness, fatigue, and pain.	24 weeks	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.
Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	24 weeks	it will be measured at week0/8/16/24
Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36)	24 weeks	it will be measured at week0/8/16/24
Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels	24 weeks	it will be measured at week0/24
Change in image of Salivary glands measured by ultrasound	24 weeks	it will be measured at week0/24
Adverse events	24 weeks	it will be measured at week0/8/16/24, and be observed, documented, and evaluated in detail.

Trial Locations

Locations (1)

Guang'anmen Hospital, China academy of Chinese Medical Sciences; 🇨🇳 Beijing, China