Hashimoto Thyroiditis, Thyroiditis
Conditions
Keywords
Anxiety, Depression, Fatigue, Photobiomodulation Therapy, Low Level Laser Therapy
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.
Interventions
OTHERPhotobiomodulation 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.
OTHERSham
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.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients in the groups did not have information with regard to which group they were included in.
Intervention model description
Randomised, sham-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Level | 3 months | 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. |
| Feeling of General Fatigue | 3 months | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 3 months | 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 . |
| Sleepiness | 3 months | 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. |
| Anxiety | 3 months | 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. |
| Depression | 3 months | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed