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Low Level Laser Therapy for Autoimmune Thyroiditis

Primary Purpose

Autoimmune Thyroiditis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low-level laser therapy
Non laser ordinary red light
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Thyroiditis focused on measuring autoimmune thyroiditis, LLLT, safety, ultrasound

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo General Hospital, Radiology Institute
  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low-level laser therapy

Non laser ordinary red light

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants with Thyroid Nodules as a Measure of Safety

Secondary Outcome Measures

Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy

Full Information

First Posted
June 23, 2014
Last Updated
May 2, 2017
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02240563
Brief Title
Low Level Laser Therapy for Autoimmune Thyroiditis
Official Title
Long-term Follow-up After Treatment of Chronic Autoimmune Thyroiditis With Low Level Laser
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Thyroiditis
Keywords
autoimmune thyroiditis, LLLT, safety, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Non laser ordinary red light
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Low-level laser therapy
Other Intervention Name(s)
Low-power laser therapy
Intervention Type
Procedure
Intervention Name(s)
Non laser ordinary red light
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants with Thyroid Nodules as a Measure of Safety
Time Frame
Six Years after Each Patient Treatment
Secondary Outcome Measure Information:
Title
Serum Levels of Anti-Thyroglobulin Antibodies as a Measure of Long Term Efficacy
Time Frame
Six Years after Each Patient Treatment
Other Pre-specified Outcome Measures:
Title
The Levothyroxine Required Dose as a Measure of Long-Term Efficacy
Time Frame
Six Years after Each Patient Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cristina Chammas, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Alberto Buchpiguel, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Danilo B Höfling, MD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital, Radiology Institute
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of Sao Paulo General Hospital
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22718472
Citation
Hofling DB, Chavantes MC, Juliano AG, Cerri GG, Knobel M, Yoshimura EM, Chammas MC. Low-level laser in the treatment of patients with hypothyroidism induced by chronic autoimmune thyroiditis: a randomized, placebo-controlled clinical trial. Lasers Med Sci. 2013 May;28(3):743-53. doi: 10.1007/s10103-012-1129-9. Epub 2012 Jun 21.
Results Reference
background
PubMed Identifier
20662037
Citation
Hofling DB, Chavantes MC, Juliano AG, Cerri GG, Romao R, Yoshimura EM, Chammas MC. Low-level laser therapy in chronic autoimmune thyroiditis: a pilot study. Lasers Surg Med. 2010 Aug;42(6):589-96. doi: 10.1002/lsm.20941.
Results Reference
background
PubMed Identifier
23316383
Citation
Hofling DB, Chavantes MC, Juliano AG, Cerri GG, Knobel M, Yoshimura EM, Chammas MC. Assessment of the effects of low-level laser therapy on the thyroid vascularization of patients with autoimmune hypothyroidism by color Doppler ultrasound. ISRN Endocrinol. 2012;2012:126720. doi: 10.5402/2012/126720. Epub 2012 Dec 17.
Results Reference
background
PubMed Identifier
30532779
Citation
Hofling DB, Chavantes MC, Buchpiguel CA, Cerri GG, Marui S, Carneiro PC, Chammas MC. Safety and Efficacy of Low-Level Laser Therapy in Autoimmune Thyroiditis: Long-Term Follow-Up Study. Int J Endocrinol. 2018 Nov 4;2018:8387530. doi: 10.1155/2018/8387530. eCollection 2018.
Results Reference
derived

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Low Level Laser Therapy for Autoimmune Thyroiditis

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