- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754607
Effects of Low-Level Laser Therapy on Oxidative Stress Levels...
Effects of Low-Level Laser Therapy on Oxidative Stress Levels, Fatigue and Quality of Life in Patients With Hashimoto Thyroiditis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SUMEYYE TUNC
- Phone Number: +90 541 811 19 92
- Email: stunc@medipol.edu.tr
Study Locations
-
-
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Istanbul, Turkey
- Sumeyye TUNC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Cases between the ages of 18-65 who applied to the Kosuyolu Istanbul Medipol Hospital Endocrinology and Metabolic Diseases Clinic between 2020-2021 and diagnosed as "Hashimoto Thyroiditis" by a specialist physician will be included in the study.
Exclusion Criteria:
- Acute infection
- Use of immunosuppressants, immunostimulants and drugs that interfere with the production, transport, and metabolism of thyroid hormones
- Thyroid nodules
- Tracheal stenosis
- Serious illness
- History of exposure to ionizing radiation and/or neoplasia in the cervical region
- Malignancy and a history of thyroid surgery
- Hypothyrodism caused by postpartum thyroiditis
- Pregnancy and breastfeeding period
- Identification and diagnosis of the cases with neurological and psychiatric disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-level laser therapy group
Low Level Laser Therapy (LLLT): Low-level laser therapy will be applied to the cases in addition to LT4 hormone replacement therapy. LLLT group will be treated using a continuous wave GaAIAs type diode laser (Intelect® Mobile Laser, Model No: 2779, Production Year: 2016; Chattanooga Group) device in the treatment area of 0.07 cm2. Continuous mode at 850 nm wavelength, 100 mW output power,1.43 W/cm2 power density and 28.57 J / cm2 energy density will be used. |
Eight target points (superior, mediolateral, inferior border of the right and left thyroid lobes, right and left sides of the isthmus) will be marked with a surgical pen by determining the thyroid borders on the skin by thyroid ultrasonography by the specialist physician.
Low-level laser (28.57
J / cm2) fixed applications will be made on the thyroid gland, approximately 1 cm from each other.
In practice, the patient's neck will be maintained in the extension position.
Each application will last 20 seconds and the radiant energy will be 2 J, the tip of the laser will be kept in contact with the skin and upright.
Duration of treatment is 6 sessions 2 days a week.
The cumulative dose will be 96 J.
|
Sham Comparator: Sham Group
Probes were placed in the sham laser group in a similar way as in the treatment group.
The screen of the laser device was active; however, the energy was set as 0 J and the power as 0 mW , respectively,and the same operations were also performed.
|
Eight target points (superior, mediolateral, inferior border of the right and left thyroid lobes, right and left sides of the isthmus) will be marked with a surgical pen by determining the thyroid borders on the skin by thyroid ultrasonography by the specialist physician.
Low-level laser (28.57
J / cm2) fixed applications will be made on the thyroid gland, approximately 1 cm from each other.
In practice, the patient's neck will be maintained in the extension position.
Each application will last 20 seconds and the radiant energy will be 2 J, the tip of the laser will be kept in contact with the skin and upright.
Duration of treatment is 6 sessions 2 days a week.
The cumulative dose will be 96 J.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidative Stress Levels
Time Frame: 3 months
|
Biochemical parameters will be taken from the patient file routinely requested by the physician.
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative Stress Index (OSI) will be calculated by measuring Total Oxidant Level (TOS) and Total Antioxidant Levels (TAS).
|
3 months
|
Malondialdehyde (MDA)
Time Frame: 3 months
|
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative stress biomarkers will be examined.
|
3 months
|
Nitric oxide (NO)
Time Frame: 3 months
|
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative stress biomarkers will be examined.
|
3 months
|
Superoxide dismutase (SOD)
Time Frame: 3 months
|
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative stress biomarkers will be examined.
|
3 months
|
Catalase (CAT)
Time Frame: 3 months
|
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative stress biomarkers will be examined.
|
3 months
|
Glutathione (GSH)
Time Frame: 3 months
|
For routine or whole blood analysis, leftover serum samples will be collected from the blood taken after fasting for 10-12 hours and the separated serum samples will be kept in a -80 °C refrigerator until the analysis day.
The analysis of the collected samples will be examined in the Biochemistry Laboratory of Istanbul Medipol University.
Oxidative stress biomarkers will be examined.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity
Time Frame: 3 months
|
Fatigue Severity Scale: The Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire scale developed in 1989.
The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.
The minimum score = 9 and maximum score possible = 63.
Higher the score = greater fatigue severity.
Another way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7.
|
3 months
|
Fatigue
Time Frame: 3 months
|
Fatigue Impact Scale: There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160.
It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items).
|
3 months
|
Quality of life (QOL)
Time Frame: 3 months
|
Short Form-36 questionnaire: The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
|
3 months
|
Behavioral status (Anxiety)
Time Frame: 3 months
|
Beck Anxiety Scale: A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".
|
3 months
|
Behavioral status (Depression)
Time Frame: 3 months
|
Beck Depression Scale: Scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
|
3 months
|
Sleep Quality
Time Frame: 3 months
|
Pittsburgh Sleep Quality Index: In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).
The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.
|
3 months
|
Sleepiness
Time Frame: 3 months
|
Epworth Sleepiness Scale: Score: Scores can be interpreted as follows: 0-5 lower normal daytime sleepiness. 6-10 normal daytime sleepiness. 11-12 mild excessive daytime symptoms. 13-15 moderate excessive daytime symptoms. 16-24 severe excessive daytime symptoms. |
3 months
|
Physical activity level
Time Frame: 3 months
|
International Physical Activity Questionnaire Short Form: IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting.
From IPAQ-SF, data were converted to Metabolic Equivalent minutes per week (MET-min/week) using.
Compendium average MET score (Walking = 3.3 METs, Moderate Physical Activity = 4.0 METs and Vigorous Physical Activity = 8.0 METs).
|
3 months
|
Grip Strength
Time Frame: 3 months
|
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. It is most useful when multiple measurements are taken over time to track performance. Jamar hand dynamometer was used to assess wrist grip strength. |
3 months
|
Collaborators and Investigators
Investigators
- Study Director: Şükriye Leyla ALTUNTAŞ, Medipol University
- Study Chair: Murat ATMACA, Istanbul Medipol University Hospital
- Principal Investigator: Sümeyye TUNÇ, Medipol University
- Study Chair: Çağrı ÇAKICI, Medipol University
- Study Chair: Türkan YİĞİTBAŞI, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol University (Registry Identifier: 10840098-604.01.01-E.10470)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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