Sjogren's SyndromePhase 2NCT02691377
Acupuncture for Primary Sjögren Syndrome
A Phase 2 study testing acupuncture group in people with Sjogren's Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether acupuncture is effective and safe in the treatment of Primary Sjögren Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- acupuncture group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.
- With the symptoms of primary Sjögren syndrome less than 5 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital, China academy of Chinese Medical Sciences
Beijing, 100053
Xinyao Zhou, MD, +8610-88001030, xyz_1102@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Sjogren's Syndrome
- Being tested
- acupuncture group, Sham Acupuncture group
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture groupDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (8)
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.
Measured: 24 weeks
Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
it will be measured at week0/8/16/24
Measured: 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
Measured: 24 weeks
Change in Hospital Anxiety and Depression (HAD) scale score
it will be measured at week0/8/16/24
Measured: 24 weeks
Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels
it will be measured at week0/24
Measured: 24 weeks
Change in image of Salivary glands measured by ultrasound
it will be measured at week0/24
Measured: 24 weeks
Change in Schirmer test score and unstimulated salivary flow
it will be measured at week0/8/16/24
Measured: 24 weeks
Adverse events
it will be measured at week0/8/16/24, and be observed, documented, and evaluated in detail.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Xinyao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Xinyao Zhou, MD, Principal investigator, Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691377
- Sponsor's protocol ID
- 2015S320
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 35602489Jiang 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.
PubMed 28103850
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture for Primary Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT02691377
- Acronym / sponsor ID
- 2015S320
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Device: acupuncture groupParticipants 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. |
| Sham Acupuncture group | Sham comparator | Device: Sham Acupuncture groupParticipants will receive sham acupuncture for 8 weeks. The procedure is the same as the acupuncture arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To fulfill the American-European Consensus Group Criteria for primary Sjögren syndrome.
- With the symptoms of primary Sjögren syndrome less than 5 years.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture groupAcupoints 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. | Device | Acupuncture group |
| Sham Acupuncture groupThe 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. | Device | Sham Acupuncture group |
Primary outcome
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.
8 secondary outcomes
Change in NAS of each item including dryness, fatigue, and pain.
Time frame: 24 weeks
Change in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 24 weeks
Change in Medical Outcome Study Short Form 36 Short-Form Health Survey (SF-36)
Time frame: 24 weeks
Change in Hospital Anxiety and Depression (HAD) scale score
Time frame: 24 weeks
Change in serum Immunoglobulin G (IgG),immunoglobulin A (IgA), and immunoglobulin M (IgM) levels
Time frame: 24 weeks
Change in image of Salivary glands measured by ultrasound
Time frame: 24 weeks
Change in Schirmer test score and unstimulated salivary flow
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Derived from this study: PubMed 35602489Zhou 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.
- Derived from this study: PubMed 28103850Jiang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinyao Zhou, MD principal investigator
Guang'anmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture group in people with Sjogren's Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyao Zhou, MD (+8610-88001030, xyz_1102@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02691377, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.