Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Headache
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study group
The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month
Intervention: Laser theapy (Device)
Control group
using LLLT without output adjustment of the parameters
Intervention: Laser theapy (Device)
Outcomes
Primary Outcomes
Headache
Time Frame: 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
Headache
Time Frame: Baseline
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 Outcomes
- Ct finding(One month)
- Fatigue(One month)
- Ct finding(Baseline)
- Fatigue(Baseline)
Investigators
Olfat Ibrahim Ali
Assistant Professor
Cairo University