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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05861817
Other study ID # Chronic rhinosinusitis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2022
Est. completion date February 1, 2023

Study information

Verified date May 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Laser theapy
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

Locations

Country Name City State
Egypt Faculty of physical therapy, Cairo university Giza Dokki
Egypt Olfat Ibrahim Ali Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary Ct finding number of sinus opacifications before and after intervention. Baseline
Secondary Ct finding number of sinus opacifications before and after intervention. One month
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