Effect of Photobiomodulation Therapy in Patients With Hashimoto's Thyroiditis

Medipol Health Group

Status: Completed

Conditions: Thyroiditis; Hashimoto Thyroiditis

Treatments: Other: Sham; Other: Photobiomodulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06735040

IMU-FTR-ST-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Photobiomodulation Therapy Group

Active Comparator group

Description:

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.

Treatment:

Other: Photobiomodulation Therapy

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Other: Sham