Effect of Photobiomodulation Therapy in Patients With Hashimoto's Thyroiditis

NCT06735040 | Completed

• 1 other identifier: IMU-FTR-ST-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The standard lifelong treatment for Hashimoto's thyroiditis (HT), a chronic autoimmune disease, is levothyroxine (LT4) therapy. Despite LT4 replacement therapy, patients continue to experience persistent fatigue, deterioration in psychological and general well-being. Our study was conducted to investigate the effects of photobiomodulation therapy (PMBT) combined with LT4 replacement therapy on fatigue and behavioural status in patients with HT.

Conditions

Hashimoto Thyroiditis; Thyroiditis

Keywords

Anxiety; Depression; Fatigue; Photobiomodulation Therapy; Low Level Laser Therapy

Outcome Measures

Primary Outcomes (2)

• Fatigue Level

  Fatigue level in all patients was assessed by Fatigue Impact Scale (FIS) and Fatigue Severity Scale (FSS). The FIS is a forty-item scale indicating the consequences of fatigue on daily life such that it includes cognitive, physical and psychosocial subscales. The sum of the subscales ranges from 0 to 40 (physical and cognitive) and 0-80 (psychosocial); a higher score indicates a more severe impact of fatigue in daily life. FSS assesses the degree of physical fatigue over the past week and includes nine items. Patients indicate how much they agree or disagree with the statements for each item on a seven-point Likert scale. FSS scores ≥ 4.0 indicate clinically relevant fatigue.

  3 months

• Feeling of General Fatigue

  General fatigue feeling of the individuals were evaluated by Visual Analogue Scale (VAS).Individuals were asked to mark their fatigue level on the scale. '0' means 'not tired at all' and '10'means 'very tired'.

  3 months

Secondary Outcomes (4)

• Sleep Quality

  3 months

• Sleepiness

  3 months

• Anxiety

  3 months

• Depression

  3 months

Study Arms (2)

Photobiomodulation Therapy Group

ACTIVE COMPARATOR

All patients diagnosed with HT in the study were receiving LT4 treatment. In the PMBT group, in addition to thyroid hormone replacement therapy, a continuous wave GaAIAs type diode laser device (Intelect® Mobile Laser, Model No: 2779, Production Year: 2016; Chattanooga Group) was also applied to the thyroid gland in a 0.07 cm² treatment area. Continuous mode at 850 nm wavelength, 100 mW output power, 1.43 W/cm2 power density and 28.57 J/cm2 energy density (28.57 J/cm2 =100 Mw x 20 s/0.07) were used during the photobiomodulation therapy.

Other: Photobiomodulation Therapy

Sham Group

SHAM COMPARATOR

In the sham PMBT group, the probe was placed similarly to the treatment group. The screen of the laser device was active; however, the energy was set to 0 J and the power to 0 Mw, and the same procedures were also performed.

Other: Sham

Interventions

Photobiomodulation Therapy OTHER

Before each treatment session, the borders of the thyroid gland were marked with ultrasound by an endocrinology specialist. Eight target points (superior, mediolateral, inferior borders of the right and left thyroid lobes, right and left side of the isthmus) were demarked with a surgical pen. PMBT was applied to the marked areas on the thyroid gland, which were approximately 1 cm apart from each other.

Also known as: Low Level Laser Therapy

Photobiomodulation Therapy Group

Sham OTHER

In the sham PMBT group, the probe was placed similarly to the treatment group. The screen of the laser device was active; however, the energy was set to 0 J and the power to 0 Mw, and the same procedures 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:

• The study included patients over the age of eighteen years who were diagnosed with HT by a specialist physician and followed up with LT4 treatment.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Sümeyye TUNÇ

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hashimoto Disease; Thyroiditis; Anxiety Disorders; Depression; Fatigue

Interventions

Low-Level Light Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Şükriye Leyla ALTUNTAŞ

  Medipol University

  STUDY DIRECTOR

• Murat ATMACA

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients in the groups did not have information with regard to which group they were included in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomised, sham-controlled study

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: January 28, 2021
• Primary Completion: January 15, 2023
• Study Completion: February 15, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)