An interventional study of Photobiomodulation Therapy and Sham in Hashimoto Thyroiditis and Thyroiditis, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 31 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
Time frame: 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'.
Time frame: 3 months
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" .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istanbul Medipol University Hospital →