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

Fatigue Clinical Trial

— Sinusitis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861817
• Other study ID #: Chronic rhinosinusitis
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• CT
• Fatigue
• Headache
• Rhinosinusitis
• Sinusitis

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