Low Level Laser Therapy for Autoimmune Thyroiditis

NCT02240563 | Completed

• 1 other identifier: CAPPesq 11459
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Autoimmune Thyroiditis

Keywords

autoimmune thyroiditis; LLLT; safety; ultrasound

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Thyroid Nodules as a Measure of Safety

  Six Years after Each Patient Treatment

Secondary Outcomes (1)

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

  Six Years after Each Patient Treatment

Other Outcomes (1)

• The Levothyroxine Required Dose as a Measure of Long-Term Efficacy

  Six Years after Each Patient Treatment

Study Arms (2)

Low-level laser therapy

EXPERIMENTAL

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

Non laser ordinary red light

PLACEBO COMPARATOR

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

Interventions

Low-level laser therapy PROCEDURE

Also known as: Low-power laser therapy

Low-level laser therapy

Non laser ordinary red light PROCEDURE

Also known as: Placebo

Non laser ordinary red light

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (2)

University of Sao Paulo General Hospital, Radiology Institute

São Paulo, 05403-000, Brazil

Location

University of Sao Paulo General Hospital

São Paulo, Brazil

Location

Related Publications (4)

• 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.

  PMID: 22718472 BACKGROUND

• 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.

  PMID: 20662037 BACKGROUND

• 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.

  PMID: 23316383 BACKGROUND

• 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.

  PMID: 30532779 DERIVED

MeSH Terms

Conditions

Thyroiditis, Autoimmune

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Maria Cristina Chammas, MD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

• Carlos Alberto Buchpiguel, PhD

  University of Sao Paulo General Hospital

  STUDY CHAIR

• Danilo B Höfling, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, University of Sao Paulo General Hospital

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

BR (2)