Effects of Low-Level Laser Therapy on Oxidative Stress Levels

NCT04754607 | Completed

• 1 other identifier: IMU-FTR-ST-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Oxidative Stress Levels

  Biochemical parameters will be taken from the patient file routinely requested by the physician. For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative Stress Index (OSI) will be calculated by measuring Total Oxidant Level (TOS) and Total Antioxidant Levels (TAS).

  3 months

• Malondialdehyde (MDA)

  For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative stress biomarkers will be examined.

  3 months

• Nitric oxide (NO)

  For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative stress biomarkers will be examined.

  3 months

• Superoxide dismutase (SOD)

  For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative stress biomarkers will be examined.

  3 months

• Catalase (CAT)

  For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative stress biomarkers will be examined.

  3 months

• Glutathione (GSH)

  For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day. The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University. Oxidative stress biomarkers will be examined.

  3 months

Secondary Outcomes (1)

• Quality of life (QOL)

  3 months

Study Arms (2)

Low Level Laser Therapy Group

ACTIVE COMPARATOR

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.

Other: Low Level Laser Therapy

Sham Group

SHAM COMPARATOR

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

Other: Sham

Interventions

Low Level Laser Therapy 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.

Low Level Laser Therapy Group

Sham 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.

Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Sümeyye TUNÇ

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hashimoto Disease; Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Autoimmune Diseases

Interventions

Low-Level Light Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Şükriye Leyla ALTUNTAŞ

  Medipol University

  STUDY DIRECTOR

• Murat ATMACA

  Medipol University

  STUDY CHAIR

• Sümeyye TUNÇ

  Medipol University

  PRINCIPAL INVESTIGATOR

• Çağrı ÇAKICI

  Medipol University

  STUDY CHAIR

• Türkan YİĞİTBAŞI

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Physiotherapist, Lecturer

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 15, 2021
• Study Start: February 9, 2021
• Primary Completion: April 15, 2022
• Study Completion: June 30, 2022
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)