NCT05861817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 28, 2022

Last Update Submit

May 6, 2023

Conditions

RhinosinusitisHeadacheFatigueCT

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Fatigue

    Baseline

  • Fatigue

    One month

  • Ct finding

    Baseline

  • Ct finding

    One month

Study Arms (2)

Study group

EXPERIMENTAL

The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month

Device: Laser theapy

Control group

SHAM COMPARATOR

using LLLT without output adjustment of the parameters

Device: Laser theapy

Interventions

Laser theapyDEVICE

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

Control groupStudy group

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients suffering from mild to moderate symptoms.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of physical therapy, Cairo university

Giza, Dokki, 12611, Egypt

Location

Olfat Ibrahim Ali

Giza, Dokki, 12611, Egypt

Location

Related Publications (1)

  • Abdulrashid NA, Ali OI, Elsharkawy MA. Effect of photobiomodulation therapy on headache, and fatigue in patients with chronic rhinosinusitis: a randomized controlled study. Lasers Med Sci. 2024 Feb 15;39(1):62. doi: 10.1007/s10103-024-04011-4.

    PMID: 38358423DERIVED

MeSH Terms

Conditions

RhinosinusitisHeadacheFatigue

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olfat I Ali, PhD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2022

First Posted

May 17, 2023

Study Start

January 18, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)