Effect of Photobiomodulation Therapy in Patients With Hashimoto's Thyroiditis

The Effect of Photobiomodulation Therapy on Fatigue and Behavioural Status in Patients With Hashimoto's Thyroiditis

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.

Study Overview

• Status: Completed
• Conditions: Thyroiditis; Hashimoto Thyroiditis
• Intervention / Treatment: Other: Photobiomodulation Therapy; Other: Sham

Detailed Description

Photobiomodulation therapy (PMBT) induces a wide range of molecular, cellular and tissue-based therapeutic effects through a biostimulation process by inducing a photochemical reaction in the cell. Some investigations show useful effects of this treatment with regard to thyroid function, autoimmunity and vascularisation in patients with Hashimoto's thyroiditis (HT). However, little is known about the efficacy of PMBT on neuromuscular symptoms and behavioural status. Therefore, in this study we aim to contribute the present literature on PMBT and to determine the clinical efficacy of PMBT. To the best of our knowledge, this study is the first paper to discuss the symptomatic efficacy of PMBT in patients with HT. Here, we investigate the effects of PMBT applied in combination with LT4 treatment on fatigue, sleep quality and behavioural status in people diagnosed with HT.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sümeyye TUNÇ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclusion criteria were acute infection, use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport and metabolism of thyroid hormones (e.g. corticosteroids, lithium and amiodarone), thyroid nodules, tracheal stenosis, history of serious illness (e.g. cancer, ischaemic coronary artery disease, stroke, renal and liver failure), history of exposure to ionising radiation or neoplasia in the cervical region, malignancy and thyroid surgery; cancer, ischaemic coronary artery disease, stroke, renal and hepatic failure), history of exposure to ionising radiation or neoplasia in the cervical region, history of malignancy and thyroid surgery, hypothyroidism caused by postpartum thyroiditis, pregnancy and lactation, neurological and psychiatric disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Photobiomodulation Therapy Group; 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; 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.; Other Names: Low Level Laser Therapy
Sham Comparator: Sham Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality based on participants' sleep experiences in the past week. The PSQI is a self-administered questionnaire that has been proven to be a valid and reliable tool for measuring sleep quality and quantity. The PSQI consists of a total of seven components and nineteen questions, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. The sum of the seven dimensional components gives global scores ranging from 0 to 21, with higher scores indicating poorer sleep quality. Those having score above 5 are considered as to have "poor sleep quality" and those having score 5 and below are considered as to have "good sleep quality" .	3 months
Sleepiness	Epworth Sleepiness Scale (ESS) was used to assess sleepiness. The ESS is a short, easy-to-administer questionnaire that subjectively assesses daytime sleepiness. The probability of falling asleep in the eight-day condition is determined by a scoring from 0 to 3 (0=no chance of napping, 1=slight chance of napping, 2=moderate chance of napping, 3=high chance of napping). The ESS score is the sum of eight item scores and ranges from 0 to 24. Higher ESS scores indicate greater daytime sleepiness.	3 months
Anxiety	The inventory consists of twenty-one items describing subjective, somatic or panic-related anxiety symptoms, respectively. Self-reports are based on a four-point Likert scale ranging from "not at all" to "severe" regarding the experience of this symptom in the past month. Higher scores indicate more severe levels of anxiety.	3 months
Depression	The Beck Depression Inventory (BDI) is a twenty-one-item self-assessment scale that measures symptoms of depression. Each item is scored from 0 to 3; the total score ranges from 0 to 63. It was stated that those having scores as seventeen and above were in the group at risk of depression. Depression levels: 0-9, minimal; 10-16, mild; 17-29, moderate; 30-63, severe.	3 months

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Şükriye Leyla ALTUNTAŞ, Medipol University; Study Chair: Murat ATMACA, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): January 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Fatigue; Photobiomodulation Therapy; Low Level Laser Therapy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Hashimoto Disease; Thyroiditis
• Other Study ID Numbers: IMU-FTR-ST-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No