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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-02-01

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.

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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.

Conditions

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Rhinosinusitis Headache Fatigue CT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month

Group Type EXPERIMENTAL

Laser theapy

Intervention Type DEVICE

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

Control group

using LLLT without output adjustment of the parameters

Group Type SHAM_COMPARATOR

Laser theapy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No