Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Change in Schirmer test score and unstimulated salivary flow(24 weeks)
- 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 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 Hospital Anxiety and Depression (HAD) scale score(24 weeks)
- Adverse events(24 weeks)
Investigators
Zhou Xinyao
Attending Physician & Lecturer
Guang'anmen Hospital of China Academy of Chinese Medical Sciences