Effects of Acupuncture on Sjögren's Syndrome

NCT04056221 | Completed DMC

• 1 other identifier: CAAE: 5419
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sjogren's Syndrome

Keywords

Sjogren's syndrome; xerostomia; xerophthalmia; acupuncture

Outcome Measures

Primary Outcomes (5)

• 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".

  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.

  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)

  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

  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."

  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.

  Before (baseline), immediately after and 1 month after acupuncture treatment.

• Changes from baseline Schirmer test scores at 2 and 3 months.

  Before (baseline), immediately after and 1 month after acupuncture treatment.

• Changes from baseline ocular surface staining at 2 and 3 months.

  Before (baseline), immediately after and 1 month after acupuncture treatment.

Study Arms (2)

acupuncture

EXPERIMENTAL

Acupuncture at the selected points.

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Similar appearance to conventional acupuncture, however, without needles skin penetration.

Other: Sham acupuncture

Interventions

Acupuncture OTHER

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.

acupuncture

Sham acupuncture OTHER

The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.

Sham acupuncture

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ana Carolina Fragoso Motta, DDS, PhD: lead

Study Sites (1)

School of Dentistry of Ribeirão Preto, University of São Paulo

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (6)

• 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.

  PMID: 18606019 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26135587 BACKGROUND

• 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.

  PMID: 29439690 BACKGROUND

• 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.

  PMID: 29851803 BACKGROUND

• 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.

  PMID: 29724255 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia; Xerophthalmia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; 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; Conjunctival Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• 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.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Oral Diagnosis

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: August 14, 2019
• Study Start: February 18, 2019
• Primary Completion: December 6, 2021
• Study Completion: October 10, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)