Effects of Low-Level Laser Therapy on Oxidative Stress Levels

NCT ID: NCT04754607

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2022-06-30

Brief Summary

Hashimoto's thyroiditis (HT) is the most commonly observed inflammatory and autoimmune disease of the thyroid gland. Recent evidence has suggested that low-level laser therapy (LLLT) can improve thyroid function and reduce levels of thyroid peroxidase antibodies (TPOAb) in patients with hypothyroidism caused by chronic autoimmune thyroiditis. In the literature, data examining the effects of LLLT on oxidative stress level and quality of life in patients with HT is limited. The aim of the study is to examine the effects of LT4 treatment combined with LLLT on thyroid autoimmunity, oxidative stress and quality of life in patients with Hashimoto's diagnosis.

Detailed Description

Hashimoto's thyroiditis (HT) is the most commonly observed inflammatory and autoimmune disease of the thyroid gland. HT is the main cause of spontaneous hypothyroidism in adults. Symptoms of hypothyroidism may develop within a few years in patients with initial euthyroidism. Many genetic and environmental factors play a role in the pathogenesis of the disease, including iodine exposure, drugs, chemicals, toxins, infections and smoking. In recent years, the relationship between oxidative stress level and thyroid autoantibodies in HT has attracted increasing attention of researchers. In the studies, it has been reported that oxidative stress levels may increase due to chronic inflammation, insufficient thyroid hormone levels, excessive autoimmune response and excessive iodine intake. OS occurs as a result of an imbalance between free radical production and antioxidant defense mechanisms. Data from clinical studies clearly show that the balance between oxidants and antioxidants shifts towards the oxidative side in patients with autoimmune thyroiditis, suggesting that oxidative stress may be a key event in the pathophysiology of the disease, independent of thyroid function. Gerenova et al. divided patients with a diagnosis of HT into three subgroups according to thyroid function (group 1-euthyroid, group 2-hypothyroid, and group 3-Levothyroxin treated patients) and pointed out cellular antioxidative deficiency in all stages of the disease. Standard treatment in patients with HT is lifelong levothyroxine (LT4) treatment, which adjusts the dose to reach normal circulating thyrotropin (TSH) levels. Studies have found persistent fatigue, psychological and general well-being, and impairments in cognitive function in patients with HT despite LT4 replacement therapy. Gomez et al. compared 152 hypothyroid women treated with levothyroxine and 238 women without hypothyroidism disorder. Female patients with hypothyroidism, despite being euthyroid, showed worse quality of life than the control group. It was emphasized that the quality of life of women with hypothyroidism should be evaluated and further research should be conducted. Recent evidence has suggested that low-level laser therapy (LLLT) can improve thyroid function and reduce levels of thyroid peroxidase antibodies (TPOAb) in patients with hypothyroidism caused by chronic autoimmune thyroiditis. LLLT is a non-invasive, painless, low-risk and low-cost method that uses the interaction of light with molecular structures to support anti-inflammatory effects and regeneration of biological tissues. In the literature, data examining the effects of LLLT on oxidative stress level and quality of life in patients with HT is limited. As far as we know, it will be the first study examining the effect of LLLT on oxidative stress and quality of life in cases diagnosed with HT. The planned research is trying to improve and expand the existing literature on LLLT in cases with HT and to contribute to the treatment protocol in order to reduce the negative consequences that may be experienced in this group of patients now and in the future. These statements show the originality of the study. Purpose: The aim of the study is to examine the effects of LT4 treatment combined with LLLT on thyroid autoimmunity, oxidative stress and quality of life in patients with Hashimoto's diagnosis.

Conditions

Hashimoto Thyroiditis; Autoimmune Thyroiditis; Thyroiditis; Thyroid Diseases; Autoimmune Diseases

Keywords

Hashimoto Thyroiditis; Oxidative Stress; Low-Level Laser Therapy; Quality of Life; Autoimmune Thyroiditis; Thyroid Hormones; Photobiomodulation Therapy

Study Design

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

Study Groups

Low Level Laser Therapy Group

Low Level Laser Therapy (LLLT): Low-level laser therapy will be applied to the cases in addition to LT4 hormone replacement therapy.

LLLT group will be treated using a continuous wave GaAIAs type diode laser (Intelect® Mobile Laser, Model No: 2779, Production Year: 2016; Chattanooga Group) device in the treatment area of 0.07 cm2. Continuous mode at 850 nm wavelength, 100 mW output power,1.43 W/cm2 power density and 28.57 J / cm2 energy density will be used.

Group Type: ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type: OTHER

Eight target points (superior, mediolateral, inferior border of the right and left thyroid lobes, right and left sides of the isthmus) will be marked with a surgical pen by determining the thyroid borders on the skin by thyroid ultrasonography by the specialist physician. Low-level laser (28.57 J / cm2) fixed applications will be made on the thyroid gland, approximately 1 cm from each other. In practice, the patient's neck will be maintained in the extension position. Each application will last 20 seconds and the radiant energy will be 2 J, the tip of the laser will be kept in contact with the skin and upright. Duration of treatment is 6 sessions 2 days a week. The cumulative dose will be 96 J.

Sham Group

Probes were placed in the sham laser group in a similar way as in the treatment group.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Probes were placed in the sham laser group in a similar way as in the treatment group. The screen of the laser device was active; however, the energy was set as 0 J and the power as 0 mW , respectively,and the same operations were also performed.

Interventions

Low Level Laser Therapy

Eight target points (superior, mediolateral, inferior border of the right and left thyroid lobes, right and left sides of the isthmus) will be marked with a surgical pen by determining the thyroid borders on the skin by thyroid ultrasonography by the specialist physician. Low-level laser (28.57 J / cm2) fixed applications will be made on the thyroid gland, approximately 1 cm from each other. In practice, the patient's neck will be maintained in the extension position. Each application will last 20 seconds and the radiant energy will be 2 J, the tip of the laser will be kept in contact with the skin and upright. Duration of treatment is 6 sessions 2 days a week. The cumulative dose will be 96 J.

Intervention Type: OTHER

Sham

Probes were placed in the sham laser group in a similar way as in the treatment group. The screen of the laser device was active; however, the energy was set as 0 J and the power as 0 mW , respectively,and the same operations were also performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Cases between the ages of 18-65 who applied to the Kosuyolu Istanbul Medipol Hospital Endocrinology and Metabolic Diseases Clinic between 2020-2021 and diagnosed as "Hashimoto Thyroiditis" by a specialist physician will be included in the study.

Exclusion Criteria

• Acute infection
• Use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport, and metabolism of thyroid hormones
• Thyroid nodules
• Tracheal stenosis
• Serious illness
• History of exposure to ionizing radiation and/or neoplasia in the cervical region
• Malignancy and a history of thyroid surgery
• Hypothyrodism caused by postpartum thyroiditis
• Pregnancy and breastfeeding period
• Identification and diagnosis of the cases with neurological and psychiatric disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

sumeyye tunc

MSc, Physiotherapist, Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şükriye Leyla ALTUNTAŞ

Role: STUDY_DIRECTOR

Medipol University

Murat ATMACA

Role: STUDY_CHAIR

Medipol University

Sümeyye TUNÇ

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Çağrı ÇAKICI

Role: STUDY_CHAIR

Medipol University

Türkan YİĞİTBAŞI

Role: STUDY_CHAIR

Medipol University

Locations

Sümeyye TUNÇ

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IMU-FTR-ST-01

Identifier Type: -

Identifier Source: org_study_id