Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.

Study Overview
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Brief Summary
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This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

Detailed Description
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Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated with reductions in patient quality of life (QOL), sleep quality, and daily productivity. It has been suggested that low-level laser can be used in treating chronic sinusitis but there are limited studies about its usage. HYPOTHESES: There is no statistically significant effect of laser therapy on headache, fatigue, or CT finding in patients with chronic sinusitis.

Official Title
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Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.

Conditions
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Rhinosinusitis, Headache, Fatigue, CT

Intervention / Treatment
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* Device: Laser theapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from mild to moderate symptoms. Exclusion Criteria: Pregnant or breastfeeding women Patients with a definite deviated nasal septum, sinusitis, or history of operation within the last 6 months. Patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases; • patients with long-term use of corticosteroids or immunosuppressive agents. Patients with hypersensitivity to the laser. Patients who were involved in another clinical study within 30 days. Patients who were unable to comply with the follow-up schedules. patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs whi

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month | Device: Laser theapy<br>* participants were randomized into either the LLLT group or sham treatment group by a computer-generated random number. The participants were treated using LLLT (904nm and 2.5 J/ sinus). treatment was delivered for one month<br>|
| Sham Comparator: Control group<br>using LLLT without output adjustment of the parameters | Device: Laser theapy<br>* participants were randomized into either the LLLT group or sham treatment group by a computer-generated random number. The participants were treated using LLLT (904nm and 2.5 J/ sinus). treatment was delivered for one month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache | Headache was measured using headache scale at the beginning and end of the intervention. The scale ranged from zero to 10. The higher the scale the higher the headache | Baseline | 
| Headache | Headache was measured using headache scale at the beginning and end of the intervention. The scale ranged from zero to 10. The higher the scale the higher the headache | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Fatigue was measured using fatigue scale at the beginning and end of the intervention. The scale ranged from zero to 10. The higher the scale the higher the fatigue value. | Baseline | 
| Fatigue | Fatigue was measured using fatigue scale at the beginning and end of the intervention. The scale ranged from zero to 10. The higher the scale the higher the fatigue value. | One month | 
| Ct finding | number of sinus opacifications before and after intervention. | Baseline | 
| Ct finding | number of sinus opacifications before and after intervention. | One month |