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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

CT
Rhinosinusitis
Fatigue
Headache

Treatments

Device: Laser theapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05861817
Chronic rhinosinusitis

Details and patient eligibility

About

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

Full 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.

Enrollment

31 patients

Sex

All

Ages

19 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

31 participants in 2 patient groups

Study group
Experimental group
Description:
The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month
Treatment:
Device: Laser theapy
Control group
Sham Comparator group
Description:
using LLLT without output adjustment of the parameters
Treatment:
Device: Laser theapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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