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

Not Applicable

Completed

• Conditions: Fatigue; Rhinosinusitis; CT; Headache
• Interventions: Device: Laser theapy

• Registration Number: NCT05861817
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-05-28
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-06
• Last Update Submitted: 2023-05-06
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Laser theapy	using LLLT without output adjustment of the parameters
Study group	Laser theapy	The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month

Primary Outcome Measures

Name	Time	Method
Headache	One month	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

Secondary Outcome Measures

Name	Time	Method
Ct finding	One month	number of sinus opacifications before and after intervention.
Fatigue	One month	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.

Trial Locations

Locations (2)

Faculty of physical therapy, Cairo university; 🇪🇬 Giza, Dokki, Egypt

Olfat Ibrahim Ali; 🇪🇬 Giza, Dokki, Egypt