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Low Level Laser Therapy for Autoimmune Thyroiditis

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ClinicalTrials.gov Identifier: NCT02240563
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Danilo Bianchini Hofling, University of Sao Paulo General Hospital

Brief Summary:
INTRODUCTION: Chronic autoimmune thyroiditis (TCA) is the main cause of acquired hypothyroidism, which requires continuous treatment with levothyroxine (LT4). A randomized, placebo-controlled trial including 43 patients with hypothyroidism caused by TCA without nodules on ultrasonography study (US) was conducted from March 2006 to March 2009 (NCT01129492). Among them, 23 were submitted to low-level laser therapy (LLLT) and 20 to placebo. The LLLT was effective in improving the echogenicity, the volume and of the thyroid vascularization pattern by US. There was also improvement in the thyroid function and reduction of serum thyroid peroxidase antibodies (TPOAb). Although the results have shown promising and LLLT has shown to be safe in many study models, the long-term LLLT actions on the thyroid parenchyma are unknown. Thus, the objective of this study is to perform biochemical tests and thyroid US six years after the clinical trial interventions to evaluate levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature of nodules in the gland and then compare these variables between LLLT and placebo groups. METHODS: This study will include the trial participants performed six years before. The levothyroxine dose and serum levels of thyrotropin (TSH), T3, T4, free T4, TPOAb and anti-thyroglobulin antibodies (TgAb) will be evaluated in these patients. The thyroid US will assess the texture (with particular attention to identifying nodules), echogenicity, volume, as well as vascularization of the gland. The US nodules features, such as dimensions, shape, margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification, internal content, vascularization pattern and resistivity index will be searched. Regional lymph nodes and other characteristics will be also investigated. The USs will be carried out by only one examiner who will be blinded for the previously performed intervention (LILT or placebo). The same investigator will execute a fine needle aspiration (FNA) of patients with thyroid nodules. The cytological analysis of the material collected from the nodules will be undertaken by a pathologist who will be also blinded for the treatment assignments. RESULTS: The following variables will be compared between the two groups: levothyroxine doses, antithyroid antibodies, US parameters, thyroid nodules (if detected) and in this case, the result of their respective FNA.

Condition or disease Intervention/treatment Phase
Autoimmune Thyroiditis Procedure: Low-level laser therapy Procedure: Non laser ordinary red light Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Follow-up After Treatment of Chronic Autoimmune Thyroiditis With Low Level Laser
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-level laser therapy
This group of patients was treated with a continuous wave diode laser device (830 nanometer, infrared) with a beam area of 0.002827 cm2 using the punctual method on the continuous emission mode at an output power of 50 milliwatts and a fluence of 707 Joules/cm2 six years before.
Procedure: Low-level laser therapy
Other Name: Low-power laser therapy

Placebo Comparator: Non laser ordinary red light
This group of patients was treated using the same method and equipment, except that a non laser ordinary red light, an output power of 0.1 Watt and a fluence of 1.41 Joules/cm2 and an irradiance value of 0.0002827 Watts/cm2 (the placebo), indistinguishable from the laser beam, was used. Therefore, the patients were blinded to which treatment they received.
Procedure: Non laser ordinary red light
Other Name: Placebo




Primary Outcome Measures :
  1. Number of Participants with Thyroid Nodules as a Measure of Safety [ Time Frame: Six Years after Each Patient Treatment ]

Secondary Outcome Measures :
  1. Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy [ Time Frame: Six Years after Each Patient Treatment ]

Other Outcome Measures:
  1. The Levothyroxine Required Dose as a Measure of Long-Term Efficacy [ Time Frame: Six Years after Each Patient Treatment ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (NCT01129492)

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Exclusion Criteria:

All patients who have hypothyroidism caused by autoimmune thyroiditis included in the aforementioned trial (NCT01129492) who underwent surgery and/or therapeutic administration of radioiodine for thyroid diseases during the period between the initial assessment of patients up to the present 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): NCT02240563


Locations
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Brazil
University of Sao Paulo General Hospital, Radiology Institute
Sao Paulo, Brazil, 05403-000
University of Sao Paulo General Hospital
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Maria Cristina Chammas, MD University of Sao Paulo General Hospital
Study Chair: Carlos Alberto Buchpiguel, PhD University of Sao Paulo General Hospital
Principal Investigator: Danilo B Höfling, MD University of Sao Paulo General Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Danilo Bianchini Hofling, MD, University of Sao Paulo General Hospital, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02240563     History of Changes
Other Study ID Numbers: CAPPesq 11459
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

Keywords provided by Danilo Bianchini Hofling, University of Sao Paulo General Hospital:
autoimmune thyroiditis
LLLT
safety
ultrasound

Additional relevant MeSH terms:
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Thyroiditis
Thyroiditis, Autoimmune
Hashimoto Disease
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases