Acupuncture for Primary Sjögren Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691377
• Other study ID #: 2015S320
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 20, 2016
• Last updated: February 26, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2016
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Xinyao Zhou, MD
• Phone: +8610-88001030
• Email: xyz_1102[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital, China academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	it will be measured at week0/8/16/24	24 weeks	No
Secondary	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	No
Secondary	Change in Hospital Anxiety and Depression (HAD) scale score	it will be measured at week0/8/16/24	24 weeks	No
Secondary	Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels	it will be measured at week0/24	24 weeks	No
Secondary	Change in image of Salivary glands measured by ultrasound	it will be measured at week0/24	24 weeks	No
Secondary	Change in Schirmer test score and unstimulated salivary flow	it will be measured at week0/8/16/24	24 weeks	No
Secondary	Adverse events	it will be measured at week0/8/16/24, and be observed, documented, and evaluated in detail.	24 weeks	Yes