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Trial record 82 of 1205 for:    acupuncture

Effects of Acupuncture on Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT04056221
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Sjogren`s Syndrome Other: Acupuncture Other: Sham acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Masking Description: Both patients and investigators who will assess the outcomes have no knowledge of the interventions assigned to individual participants.
Primary Purpose: Treatment
Official Title: Effects of Acupuncture on Xerostomia and Xerophthalmia in Sjögren's Syndrome: a Randomized, Double-blinded Clinical Trial
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: acupuncture
Acupuncture at the selected points.
Other: Acupuncture
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.
Other: Sham acupuncture
The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.




Primary Outcome Measures :
  1. 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".

  2. 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.

  3. 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)

  4. 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

  5. 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."


Secondary Outcome Measures :
  1. 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.

  2. Changes from baseline Schirmer test scores at 2 and 3 months. [ Time Frame: Before (baseline), immediately after and 1 month after acupuncture treatment. ]
    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

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056221


Contacts
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Contact: Ana Carolina F Motta, DDS, PhD +55 - 16 - 3315-4067 anacfm@usp.br

Locations
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Brazil
School of Dentistry of Ribeirão Preto, University of São Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil, 14040-904
Contact: Ana Carolina F Motta, PhD    +55-16-3315-4067    anacfm@usp.br   
Contact: Maria Cristina Borsatto, PhD    +55-16-33154016    borsatto@forp.usp.br   
Sponsors and Collaborators
Ana Carolina Fragoso Motta, DDS, PhD
Investigators
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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:
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Responsible Party: Ana Carolina Fragoso Motta, DDS, PhD, Professor of Oral Diagnosis, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04056221     History of Changes
Other Study ID Numbers: CAAE: 5419
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Carolina Fragoso Motta, DDS, PhD, University of Sao Paulo:
Sjogren`s syndrome
xerostomia
xerophthalmia
acupuncture
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases