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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05861817
• Collaborator: (none)
• Enrollment: 31
• Locations: 2
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinosinusitis; Headache; Fatigue; CT	Device: Laser theapy	N/A

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
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
• Actual Study Start Date: Jan 18, 2022
• Actual Primary Completion Date: Feb 1, 2023
• Actual Study Completion Date: Feb 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Headache [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

2. Headache [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

Secondary Outcome Measures

1. Fatigue [Baseline]

   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.

2. Fatigue [One month]

   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.

3. Ct finding [Baseline]

   number of sinus opacifications before and after intervention.

4. Ct finding [One month]

   number of sinus opacifications before and after intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of physical therapy, Cairo university	Giza	Dokki	Egypt	12611
2	Olfat Ibrahim Ali	Giza	Dokki	Egypt	12611

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Olfat I Ali, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olfat Ibrahim Ali, Assistant Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05861817
• Other Study ID Numbers: Chronic rhinosinusitis
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sinusitis; Fatigue; Headache

Study Results

No Results Posted as of May 17, 2023