Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

NCT01129492 | Completed Phase 2 DMC

• 1 other identifier: CAPPesq 375/05
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.

Conditions

Autoimmune Thyroiditis

Keywords

Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound

Outcome Measures

Primary Outcomes (1)

• The main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal.

  All patients enrolled in the study were undergoing LT4 treatment. They received 10 applications of LLLT or placebo. Thirty days after intervention, LT4 was discontinued in all patients and, if required, reintroduced. T3, T4, free T4 and TSH levels (all laboratory personnel was blinded), were assessed pre-LLLT and then 1, 2, 3, 6 and 9 months post-LT4 withdrawal. The LT4 mean dose pre-LLLT and 9 months post-LT4 withdrawal was compared both in face of normal levels of T3, T4, free T4 and TSH to evaluate LLLT effectiveness.

  LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.

Secondary Outcomes (2)

• Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.

  Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal.

• Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.

  The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT.

Study Arms (2)

Sham Laser

PLACEBO COMPARATOR

Ten applications of placebo were performed (twice a week) with the same method and Laser equipment, which has a placebo function available with a red ordinary light indistinguishable of the Laser light.

Device: Low-level Laser therapy

Active Laser

ACTIVE COMPARATOR

Ten applications of low-level Laser therapy (twice a week) were performed with a continuous wave diode laser device (830nm, beam area of 0.2827cm2), using the punctual method, continuous emission mode, output power of de 50 mW and fluence of 70J/cm2.

Device: Low-level Laser therapy

Interventions

Low-level Laser therapy DEVICE

A continuous wave (CW) diode laser device (830nm, infrared) with a beam area of 0.2827cm2 and using the punctual method, continuous emission mode, output power of de 50mW and fluence of 70J/cm2 (40 seconds at the point of application).

Also known as: Low intensity Laser therapy, Low power Laser therapy

Active Laser; Sham Laser

Eligibility Criteria

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

You may qualify if:

• Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT.
• Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies
• Ultrasonography results consistent with CAT
• Patients undergoing LT4 treatment
• Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH)

You may not qualify if:

• Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones
• CAT with normal thyroid function
• CAT with subclinical hypothyroidism
• Thyroid nodules
• Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation)
• History of Graves' disease
• Thyrotropin receptor antibody (TRAb) detectable
• Prior treatment with radioiodine
• Tracheal stenosis
• Pregnancy
• History of ionizing irradiation and/or neoplasia in the cervical area
• Previous surgical intervention in the thyroid
• Thyroid hypoplasia
• Ectopic thyroid
• Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver failure, etc.)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-001, Brazil

Location

Related Publications (1)

• Hofling DB, Chavantes MC, Acencio MM, Cerri GG, Marui S, Yoshimura EM, Chammas MC. Effects of low-level laser therapy on the serum TGF-beta1 concentrations in individuals with autoimmune thyroiditis. Photomed Laser Surg. 2014 Aug;32(8):444-9. doi: 10.1089/pho.2014.3716.

  PMID: 25101534 DERIVED

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Thyroid Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Danilo B Höfling, Dr.

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 24, 2010
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 24, 2010

Record last verified: 2009-04

Locations

BR (1)