Acupuncture for Primary Sjögren Syndrome

NCT02691377 | Unknown Phase 2

• 1 other identifier: 2015S320
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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 Hospital Anxiety and Depression (HAD) scale score

  24 weeks

• Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels

  24 weeks

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Sham Acupuncture group

SHAM COMPARATOR

Participants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm.

Device: Sham Acupuncture group

Interventions

acupuncture group DEVICE

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.

Acupuncture group

Sham Acupuncture group DEVICE

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.

Sham Acupuncture group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.
• With the symptoms of primary Sjögren syndrome less than 5 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Related Publications (2)

• 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.

  PMID: 35602489 DERIVED

• 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.

  PMID: 28103850 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xinyao Zhou, MD

  Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyao Zhou, MD

CONTACT

+8610-88001030; xyz_1102@126.com

Ran Pang, MD

CONTACT

+8610-88001040; pangran2002@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician & Lecturer

Study Record Dates

• First Submitted: February 20, 2016
• First Posted: February 25, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

CN (1)