Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2016-03-31
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
acupuncture group
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.
Sham Acupuncture group
Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.
Sham Acupuncture group
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.
Interventions
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acupuncture group
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.
Sham Acupuncture group
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.
Eligibility Criteria
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Inclusion Criteria
* With the symptoms of primary Sjögren syndrome less than 5 years.
Exclusion Criteria
* Taking or taken medicine for primary Sjögren syndrome within last 4 weeks before the enrollment.
18 Years
65 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Zhou Xinyao
Attending Physician & Lecturer
Principal Investigators
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Xinyao Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital
Locations
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Guang'anmen Hospital, China academy of Chinese Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Xinyao Zhou, MD
Role: primary
References
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Zhou X, Xu H, Chen J, Wu H, Zhang Y, Tian F, Tang X, Zhang H, Ge L, Li K, Jiang W, Liu Z, Jiang Q. Efficacy and Safety of Acupuncture on Symptomatic Improvement in Primary Sjogren's Syndrome: A Randomized Controlled Trial. Front Med (Lausanne). 2022 May 6;9:878218. doi: 10.3389/fmed.2022.878218. eCollection 2022.
Jiang Q, Zhang H, Pang R, Chen J, Liu Z, Zhou X. Acupuncture for Primary Sjogren Syndrome (pSS) on symptomatic improvements: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2017 Jan 19;17(1):61. doi: 10.1186/s12906-017-1559-9.
Other Identifiers
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2015S320
Identifier Type: -
Identifier Source: org_study_id