Back to resultsEffect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis. (Sinusitis)
Primary Purpose
Rhinosinusitis, Headache, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser theapy
Sponsored by
About this trial
This is an interventional treatment trial for Rhinosinusitis
Eligibility Criteria
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
Sites / Locations
- Faculty of physical therapy, Cairo university
- Olfat Ibrahim Ali
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Study group
Control group
Arm Description
The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month
using LLLT without output adjustment of the parameters
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
Ct finding
number of sinus opacifications before and after intervention.
Ct finding
number of sinus opacifications before and after intervention.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05861817
Brief Title
Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.
Acronym
Sinusitis
Official Title
Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis, Headache, Fatigue, CT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
using LLLT without output adjustment of the parameters
Intervention Type
Device
Intervention Name(s)
Laser theapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Headache
Description
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
Time Frame
Baseline
Title
Headache
Description
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
Time Frame
One month
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
Baseline
Title
Fatigue
Description
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.
Time Frame
One month
Title
Ct finding
Description
number of sinus opacifications before and after intervention.
Time Frame
Baseline
Title
Ct finding
Description
number of sinus opacifications before and after intervention.
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfat I Ali, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy, Cairo university
City
Giza
State/Province
Dokki
ZIP/Postal Code
12611
Country
Egypt
Facility Name
Olfat Ibrahim Ali
City
Giza
State/Province
Dokki
ZIP/Postal Code
12611
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.
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