Low Level Laser Therapy for Autoimmune Thyroiditis

May 2, 2017 updated by: Danilo Bianchini Hofling, University of Sao Paulo General Hospital

Long-term Follow-up After Treatment of Chronic Autoimmune Thyroiditis With Low Level Laser

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

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

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • University of Sao Paulo General Hospital, Radiology Institute
      • São Paulo, Brazil
        • University of Sao Paulo General Hospital

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

-

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.

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: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Thyroid Nodules as a Measure of Safety
Time Frame: Six Years after Each Patient Treatment
Six Years after Each Patient Treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy
Time Frame: Six Years after Each Patient Treatment
Six Years after Each Patient Treatment

Other Outcome Measures

Outcome Measure
Time Frame
The Levothyroxine Required Dose as a Measure of Long-Term Efficacy
Time Frame: Six Years after Each Patient Treatment
Six Years after Each Patient Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • 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 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

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

September 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPesq 11459

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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