Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

NCT ID: NCT01129492

Last Updated: 2010-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-03-31

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.

Detailed Description

Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that lead progressively to thyroiditis. There is no effective therapy available that can change the natural history of CAT, which presents a high incidence of hypothyroidism and requires continuous treatment with levothyroxine (LT4).

Laser light can be valuable since the local and systemic actions of low-level laser therapy (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate regeneration of various tissues and, in animal thyroids, can lead to improvement in microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels. Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function, their concentration of thyroid autoantibodies, and the parameters of their ultrasonography study.

Conditions

Autoimmune Thyroiditis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Laser

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.

Group Type: PLACEBO_COMPARATOR

Low-level Laser therapy

Intervention Type: 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).

Active Laser

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.

Group Type: ACTIVE_COMPARATOR

Low-level Laser therapy

Intervention Type: 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).

Interventions

Low-level Laser therapy

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).

Intervention Type: DEVICE

Other Intervention Names

Low intensity Laser therapy; Low power Laser therapy

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

University of São Paulo General Hospital - Radiology Departament

Principal Investigators

Danilo B Höfling, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo General Hospital

Locations

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 25101534 (View on PubMed)

Other Identifiers

CAPPesq 375/05

Identifier Type: -

Identifier Source: org_study_id