Acupuncture for Primary Sjögren Syndrome

Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome

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

Study Overview

• Status: Unknown
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Device: acupuncture group; Device: Sham Acupuncture group

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xinyao Zhou, MD; Phone Number: +8610-88001030; Email: xyz_1102@126.com

Study Locations

• China
  • Beijing, China, 100053
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
    • Contact: Xinyao Zhou, MD; Phone Number: +8610-88001030; Email: xyz_1102@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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_COMPARATOR: Sham Acupuncture group; Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Xinyao Zhou, MD, Guang'anmen hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: February 20, 2016
• First Submitted That Met QC Criteria: February 20, 2016
• First Posted (ESTIMATE): February 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 2015S320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED