Sjogren's SyndromeNCT04056221

Effects of Acupuncture on Sjögren's Syndrome

A study testing Acupuncture in people with Sjogren's Syndrome, run by Ana Carolina Fragoso Motta, DDS, PhD at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sjogren's Syndrome
What is being tested?: Acupuncture
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteBrazil
Study dates: 18 Feb 2019to 10 Oct 2022
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults ≥ 18 years old, both genres, who consent to participate of the study
Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism

Who cannot join

Patients who have undergone head and neck radiation therapy;
Patients with a history of neoplasias and salivary gland infections;
Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;
Patients with inability to undergo total saliva collection by established techniques;
Patients who can not attend regular acupuncture sessions;
Patients who had a change in the dosage of medications in use within 6 weeks before the start of the study.
Patients who received acupuncture therapy up to 6 weeks prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, 14040-904

Other trials in Brazil

About this study

Official title: Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial

Sjögren's syndrome (SS) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. Xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. Although some drugs may improve symptoms and prevent SS complications, they can cause significant adverse effects and even fail to relieve symptoms. Integrative and complementary techniques have become a therapeutic option for SS patients. Scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. Due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for SS patients' symptoms relief.

Read the detailed description

The present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). The research will be conducted following the CONSORT recommendations and the STRICTA extension. The study care protocol will consist in acupuncture or control intervention at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) for 8 weeks, 20 minutes sessions with 12 weeks of follow up. Complementary clinical approaches (sialometry, sialochemistry, Schirmer test, staining with topical lissamine green), and the questionnaires (OHIP-14, Eular Sjögren's Syndrome Patient Reported Index (ESSPRI), Xerostomia Inventory, ocular surface disease index (OSDI) will be performed in weeks 1, 8 and 12. The control group will consist of superficial acupuncture, or placebo, or sham. After all interventions and evaluation methods completed, data will be analyzed for their distribution and homogeneity in order to choose the most appropriate statistical test.

Conditions: Sjogren's Syndrome
Being tested: Acupuncture, Sham acupuncture
Keywords: Sjogren's syndrome, xerostomia, xerophthalmia, acupuncture
Medical subject headings: Sjogren's Syndrome, Xerostomia, Xerophthalmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
Acupuncture stimulation was done manually, using single-use acupuncture needles that will be inserted on the selected acupoints (R6, E6, E2, Ig4, VC24, TA23, B2) once a week,for 8 weeks, 20 minutes sessions with 12 weeks of follow up.
Sham acupunctureOther
The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Study groups in NCT04056221
Study group	Role	What they receive
acupuncture	Experimental	Acupuncture at the selected points. Receives: Other: Acupuncture
Sham acupuncture	Sham comparator	Similar appearance to conventional acupuncture, however, without needles skin penetration. Receives: Other: Sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months.
Instrument of data collection which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation,physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "always".
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Xerostomia Inventory score at at 2 and 3 months.
It is an 11-item questionnaire that covers both experiential and behavioral aspects of xerostomia. Scores to the 11 items are summated, providing a single score representing the subjective severity of xerostomia.
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline The Challacombe scale at at 2 and 3 months.
The purpose of this scale is to be able to visually identify and quantify whether your patient has xerostomia (dry mouth)
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 2 and 3 months.
There is a 0-10 numerical scale for each of the four domains, dryness, discomfort (including pain), global fatigue and mental fatigue
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Ocular Surface Disease Index (OSDI) at 2 and 3 months.
This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time."
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.

Secondary outcomes (3)

Changes from baseline whole unstimulated salivary flow rate at 2 and 3 months.
Samples of total saliva (saliva resulting from all salivary glands) will be collected between 8:00 am and 11:00 am, and evaluation of salivary flow will be determined by means of expectoration of saliva in graduated tube of 15 mL for a period of 15 minutes, and the volume obtained will be calculated.
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Schirmer test scores at 2 and 3 months.
Objective reflection to the lacrimal gland. Schirmer's test uses paper strips inserted into the eye for several minutes to measure the production of tears
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline ocular surface staining at 2 and 3 months.
This is a test that uses orange dye (fluorescein) and a blue light to detect foreign bodies in the eye. This test can also detect damage to the cornea.
Measured: Before (baseline), immediately after and 1 month after acupuncture treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 201910 Oct 2022

First posted14 Aug 2019
Study start18 Feb 2019
Primary completion6 Dec 2021
Study completion10 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Sjogren syndrome's patients will be randomly assigned to either acupuncture (experimental group) at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) or sham acupuncture (control group), where the needles do not penetrate the skin into non acupuncture points, for 8 weeks, 20 minutes sessions with 12 weeks of follow up.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04056221
Sponsor's protocol ID: CAAE: 5419
Status last verified: Mar 2023
First submitted: 17 Mar 2019
Last updated: 14 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to make individual participant data available to other researchers.

Publications

Deng G, Hou BL, Holodny AI, Cassileth BR. Functional magnetic resonance imaging (fMRI) changes and saliva production associated with acupuncture at LI-2 acupuncture point: a randomized controlled study. BMC Complement Altern Med. 2008 Jul 7;8:37. doi: 10.1186/1472-6882-8-37.
PubMed 18606019
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.
PubMed 28103850
Hackett KL, Deane KH, Strassheim V, Deary V, Rapley T, Newton JL, Ng WF. A systematic review of non-pharmacological interventions for primary Sjogren's syndrome. Rheumatology (Oxford). 2015 Nov;54(11):2025-32. doi: 10.1093/rheumatology/kev227. Epub 2015 Jun 30.
PubMed 26135587
Assy Z, Brand HS. A systematic review of the effects of acupuncture on xerostomia and hyposalivation. BMC Complement Altern Med. 2018 Feb 13;18(1):57. doi: 10.1186/s12906-018-2124-x.
PubMed 29439690
Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
PubMed 29851803
Kim BH, Kim MH, Kang SH, Nam HJ. Optimizing acupuncture treatment for dry eye syndrome: a systematic review. BMC Complement Altern Med. 2018 May 3;18(1):145. doi: 10.1186/s12906-018-2202-0.
PubMed 29724255

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sjogren's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial
ClinicalTrials.gov ID: NCT04056221
Acronym / sponsor ID: CAAE: 5419
Conditions: Sjogren's Syndrome
Keywords: Sjogren's syndrome, xerostomia, xerophthalmia, acupuncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Ana Carolina Fragoso Motta, DDS, PhDUniversity, hospital or other
Study start: 18 Feb 2019 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 10 Oct 2022 (actual)
First posted: 14 Aug 2019 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Sjogren syndrome's patients will be randomly assigned to either acupuncture (experimental group) at the selected acupoints (R6, E6,E2, Ig4, VC24, TA23, B2) or sham acupuncture (control group), where the needles do not penetrate the skin into non acupuncture points, for 8 weeks, 20 minutes sessions with 12 weeks of follow up.

Arm	Type	Receives
acupuncture	Experimental	Other: AcupunctureAcupuncture at the selected points.
Sham acupuncture	Sham comparator	Other: Sham acupunctureSimilar appearance to conventional acupuncture, however, without needles skin penetration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adults ≥ 18 years old, both genres, who consent to participate of the study
Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism

Key exclusion criteria (7 listed)

Patients who have undergone head and neck radiation therapy;
Patients with a history of neoplasias and salivary gland infections;
Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;
Patients with inability to undergo total saliva collection by established techniques;
Patients who can not attend regular acupuncture sessions;

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
AcupunctureAcupuncture stimulation was done manually, using single-use acupuncture needles that will be inserted on the selected acupoints (R6, E6, E2, Ig4, VC24, TA23, B2) once a week,for 8 weeks, 20 minutes sessions with 12 weeks of follow up.	Other	acupuncture
Sham acupunctureThe sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.	Other	Sham acupuncture

Primary outcome

Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
Instrument of data collection which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation,physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "always".
Changes from baseline Xerostomia Inventory score at at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
It is an 11-item questionnaire that covers both experiential and behavioral aspects of xerostomia. Scores to the 11 items are summated, providing a single score representing the subjective severity of xerostomia.
Changes from baseline The Challacombe scale at at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
The purpose of this scale is to be able to visually identify and quantify whether your patient has xerostomia (dry mouth)
Changes from baseline EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
There is a 0-10 numerical scale for each of the four domains, dryness, discomfort (including pain), global fatigue and mental fatigue
Changes from baseline Ocular Surface Disease Index (OSDI) at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time."

3 secondary outcomes

Changes from baseline whole unstimulated salivary flow rate at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline Schirmer test scores at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
Changes from baseline ocular surface staining at 2 and 3 months.
Time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Background: PubMed 18606019Deng G, Hou BL, Holodny AI, Cassileth BR. Functional magnetic resonance imaging (fMRI) changes and saliva production associated with acupuncture at LI-2 acupuncture point: a randomized controlled study. BMC Complement Altern Med. 2008 Jul 7;8:37. doi: 10.1186/1472-6882-8-37.
Background: 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.
Background: PubMed 26135587Hackett KL, Deane KH, Strassheim V, Deary V, Rapley T, Newton JL, Ng WF. A systematic review of non-pharmacological interventions for primary Sjogren's syndrome. Rheumatology (Oxford). 2015 Nov;54(11):2025-32. doi: 10.1093/rheumatology/kev227. Epub 2015 Jun 30.
Background: PubMed 29439690Assy Z, Brand HS. A systematic review of the effects of acupuncture on xerostomia and hyposalivation. BMC Complement Altern Med. 2018 Feb 13;18(1):57. doi: 10.1186/s12906-018-2124-x.
Background: PubMed 29851803Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
Background: PubMed 29724255Kim BH, Kim MH, Kang SH, Nam HJ. Optimizing acupuncture treatment for dry eye syndrome: a systematic review. BMC Complement Altern Med. 2018 May 3;18(1):145. doi: 10.1186/s12906-018-2202-0.
Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers.

Related trials for Sjogren's Syndrome

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R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
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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.

Jaciara M Gomes-Silva, DDS, PhD study chair

University of São Paulo, Ribeirão Preto, SP, Brazil.

Maria Cristina Borsato, DDS, PhD study chair

University of São Paulo, Ribeirão Preto, SP, Brazil.

Eduardo Melani Rocha, DDS, PhD study chair

University of São Paulo, Ribeirão Preto, SP, Brazil.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Sjogren's Syndrome, run by Ana Carolina Fragoso Motta, DDS, PhD at 1 site in Brazil.

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 7 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: finished, as of the sponsor's last update on 14 Mar 2023. 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 Brazil. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes from baseline Oral Health Impact Profile (OHIP-14) score at 2 and 3 months. (time frame: Before (baseline), immediately after and 1 month after acupuncture treatment.). The study lists 5 primary outcomes in all. 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 NCT04056221, which also lists 6 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 14 Mar 2023.