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IRCT20230805059035N1 IRCT 2023-09-15 Tehran University of Medical Sciences Comparring the effect of laser and ultrasound on sinus mucus inflammatin in patients with chronic rhinosinusitis (CRS) Comparing the effect of low level laser and pulsed ultrasound on sinus mucus inflammation using fractional exhaled nitric oxide in patients with chronic rhinosinusitis (CRS) 2023-10-02 anticipated 40 Complete https://irct.ir/trial/71910 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization in this study will be by the Stratified Permuted Block Randomization method, in which people are divided into two groups (ultrasound treatment group and laser treatment group) after meeting the conditions for entering the study. For this purpose, first, by Random Allocation computer software (version 1.1, Isfahan University of Medical Sciences, Iran), a random order of two letters A (ultrasound treatment) and B (laser treatment) in blocks with random numbers of 4 and 6 (for example ABBA and ABAABB are made. Then the blocks are hidden by non-transparent envelopes. In order to minimize the selection bias and ensure the concealment of the allocation of people in the groups, the randomization process is done by a person who is not in any of the other stages of the research. In this way, patients are randomly placed in one of the two groups (pulsed ultrasound treatment or low power laser treatment), Blinding description: The evaluator will be unaware of the type of treatment of the patients. N/A Chronic rhinosinusitis. Intervention 1: Intervention group: In the first intervention group, ITO 750 pulsed ultrasound therapy is used.The patient is treated with pulsed ultrasound for 5 sessions every day.In each treatment session, each maxillary sinus for 5 minutes with a dose of 1 w/cm2 and each frontal sinus for 4 minutes with a dose of 0.5 w/cm2, with an applicator with a cross section of 1 cm2 and with circular movements is treated on the surface anatomy of the corresponding sinus. The frequency used in all treatment sessions will be 1MHZ and the pulse time used will be 1ms and the pulse interval will be 9ms. Intervention 2: Intervention group: In the second intervention group, a low-level Enraf 476 laser is used. Laser treatment is done for 5 sessions every day. The surface of each sinus is divided into 6 points and each point is treated for 33 seconds with an intensity of 1 joule with a point applicator. In total, in each treatment session, each involved sinus is exposed to laser radiation for 198 seconds. . The laser used will be a continuous-type gallium aluminum arsenide diode, with a wavelength of 830 nm, and a power of 30 milliwatts. Yes - There is a plan to make this available What will be shared: The raw data of the research and its analysis will be provided to the researchers upon their request. When: After the publication of the articles resulting from the research. To whom: Researchers working in academic institutions. Conditions: The data is provided to other researchers only to study and check the treatment results. Where to obtain: Department of Physiotherapy, School of Rehabilitation of Tehran University of Medical Sciences, Islamic Revolution St, Pich Shemiran, Dr.Noureddin Nakhostin Ansari, 09122979309, nakhostin@sina.tums.ac.ir How to obtain: By sending an official university email to the corresponding author, Dr. Nooruddin Ansari (nakhostin@sina.tums.ac.ir) and requesting documents, a response will be provided as soon as possible. Comments:
public Mina Kashi Alashti
School of Rehabilitation, Pich Shemiran, Islamic Revolution St, Tehran
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 nnansari40@gmail.com Tehran University of Medical Sciences scientific Dr. Noureddin Nakhostin Ansari
School of Rehabilitation of Tehran University of Medical Sciences, Pich Shemiran, Islamic Revolution St, Tehran
Tehran Iran (Islamic Republic of) 65111-11489 +98 21 7753 3939 nnansari40@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with chronic rhinosinusitis; The duration of infection is between 3 months and a maximum of 5 years 18 years 65 years Both Not having polyp and sinus retention cyst No history of facial surgery No malignant lesions in the head and neck area Not having asthma and respiratory diseases J32.9 Chronic sinusitis, unspecified Treatment - Other Treatment - Other Intervention group: In the first intervention group, ITO 750 pulsed ultrasound therapy is used.The patient is treated with pulsed ultrasound for 5 sessions every day.In each treatment session, each maxillary sinus for 5 minutes with a dose of 1 w/cm2 and each frontal sinus for 4 minutes with a dose of 0.5 w/cm2, with an applicator with a cross section of 1 cm2 and with circular movements is treated on the surface anatomy of the corresponding sinus. The frequency used in all treatment sessions will be 1MHZ and the pulse time used will be 1ms and the pulse interval will be 9ms. Intervention group: In the second intervention group, a low-level Enraf 476 laser is used. Laser treatment is done for 5 sessions every day. The surface of each sinus is divided into 6 points and each point is treated for 33 seconds with an intensity of 1 joule with a point applicator. In total, in each treatment session, each involved sinus is exposed to laser radiation for 198 seconds. . The laser used will be a continuous-type gallium aluminum arsenide diode, with a wavelength of 830 nm, and a power of 30 milliwatts. Exhaled nitric oxide level. Timepoint: Before the start of the intervention, immediately after the intervention and one month after the intervention. Method of measurement: Fractional exhaled nitric oxide test with nitric oxide analyzer. CT scan score. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Seeing the CT scan stereotype. Total score of clinical symptoms. Timepoint: Before the start of the intervention, immediately after the intervention and one month after the intervention. Method of measurement: Sinonasal Outcome Test 22 (SNOT 22) Questionnaire. Tehran University of Medical Sciences Approved 2023-08-16 Ethics committee of Tehran University of Medical Sciences School of Rehabilitation of Tehran University of Medical Sciences, Pich Shemiran, Islamic Revolution St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)