Clinical trial NCT06735040: Effect of Photobiomodulation Therapy in Patients With Hashimoto's Thyroiditis
Official title: The Effect of Photobiomodulation Therapy on Fatigue and Behavioural Status in Patients With Hashimoto's Thyroiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hashimoto Thyroiditis
Thyroiditis
Keywords: Anxiety
Depression
Fatigue
Photobiomodulation Therapy
Low Level Laser Therapy
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, sham-controlled study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue Level
timeFrame: 3 months
measure: Feeling of General Fatigue
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Quality
timeFrame: 3 months
measure: Sleepiness
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sümeyye TUNÇ
Study officials:
affiliation: Medipol University
name: Şükriye Leyla ALTUNTAŞ
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Murat ATMACA
role: STUDY_CHAIR
References: