- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04056221
Effects of Acupuncture on Sjögren's Syndrome
March 11, 2023 updated by: Ana Carolina Fragoso Motta, DDS, PhD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14040-904
- School of Dentistry of Ribeirão Preto, University of São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acupuncture
Acupuncture at the selected points.
|
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 Comparator: Sham acupuncture
Similar appearance to conventional acupuncture, however, without needles skin penetration.
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The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
Before (baseline), immediately after and 1 month after acupuncture treatment.
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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.
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Before (baseline), immediately after and 1 month after acupuncture treatment.
|
Changes from baseline The Challacombe scale at at 2 and 3 months.
Time Frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
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The purpose of this scale is to be able to visually identify and quantify whether your patient has xerostomia (dry mouth)
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Before (baseline), immediately after and 1 month after acupuncture treatment.
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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
|
Before (baseline), immediately after and 1 month after acupuncture treatment.
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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."
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Before (baseline), immediately after and 1 month after acupuncture treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
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Before (baseline), immediately after and 1 month after acupuncture treatment.
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Changes from baseline Schirmer test scores at 2 and 3 months.
Time Frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
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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
|
Before (baseline), immediately after and 1 month after acupuncture treatment.
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Changes from baseline ocular surface staining at 2 and 3 months.
Time Frame: Before (baseline), immediately after and 1 month after acupuncture treatment.
|
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.
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Before (baseline), immediately after and 1 month after acupuncture treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jaciara M Gomes-Silva, DDS, PhD, University of São Paulo, Ribeirão Preto, SP, Brazil.
- Study Chair: Maria Cristina Borsato, DDS, PhD, University of São Paulo, Ribeirão Preto, SP, Brazil.
- Study Chair: Eduardo Melani Rocha, DDS, PhD, University of São Paulo, Ribeirão Preto, SP, Brazil.
- Study Chair: Fabiola R Oliveira, DDS, PhD, University of São Paulo, Ribeirão Preto, SP, Brazil.
- Study Chair: Maria da Conceição P Saraiva, DDS, PhD, University of São Paulo, Ribeirão Preto, SP, Brazil.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2019
Primary Completion (Actual)
December 6, 2021
Study Completion (Actual)
October 10, 2022
Study Registration Dates
First Submitted
March 17, 2019
First Submitted That Met QC Criteria
August 11, 2019
First Posted (Actual)
August 14, 2019
Study Record Updates
Last Update Posted (Actual)
March 14, 2023
Last Update Submitted That Met QC Criteria
March 11, 2023
Last Verified
March 1, 2023
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
- CAAE: 5419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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