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Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

Primary Purpose

Autoimmune Thyroiditis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Low-level Laser therapy
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, Laser, Therapy, Thyroid, Ultrasound

Eligibility Criteria

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

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.)

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sham Laser

Active Laser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.
Thyroid peroxidase (TPOAb) and thyroglobulin (TgAb) autoantibodies were both determined prior to LLLT and in the 1st, 2nd, 3rd, 6th and 9th months after LT4 withdrawal. All laboratory personnel was blinded to treatment assignment throughout the study.
Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.
B-mode sonography (volume, texture and echogenicity using computerized histogram) as well as power Doppler (vascularization) and pulsed Doppler (maximal systolic peak velocity and resistance index for the thyroid arteries) were performed and compared pre- and 30 days post-intervention by only one experienced and blind investigator, during the use of the same doses of LT4.

Full Information

First Posted
May 14, 2010
Last Updated
May 21, 2010
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01129492
Brief Title
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis
Official Title
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Thyroiditis
Keywords
Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham Laser
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Active Laser
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low-level Laser therapy
Other Intervention Name(s)
Low intensity Laser therapy, Low power Laser therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal.
Secondary Outcome Measure Information:
Title
Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations.
Description
Thyroid peroxidase (TPOAb) and thyroglobulin (TgAb) autoantibodies were both determined prior to LLLT and in the 1st, 2nd, 3rd, 6th and 9th months after LT4 withdrawal. All laboratory personnel was blinded to treatment assignment throughout the study.
Time Frame
Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal.
Title
Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters.
Description
B-mode sonography (volume, texture and echogenicity using computerized histogram) as well as power Doppler (vascularization) and pulsed Doppler (maximal systolic peak velocity and resistance index for the thyroid arteries) were performed and compared pre- and 30 days post-intervention by only one experienced and blind investigator, during the use of the same doses of LT4.
Time Frame
The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT.

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: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danilo B Höfling, Dr.
Organizational Affiliation
University of São Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
São Paulo
ZIP/Postal Code
05403-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25101534
Citation
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.
Results Reference
derived

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Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis

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