Low Level Laser Therapy for Autoimmune Thyroiditis
Condition: Autoimmune Thyroiditis
MeSH terms: Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease
Study type: Interventional

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.
    


Intervention name(s): Low-level laser therapy; Non laser ordinary red light
Intervention type(s): Procedure; Procedure
Other intervention name(s): Low-power laser therapy; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autoimmune thyroiditis; LLLT; safety; ultrasound