RhinosinusitisSinusitisNCT05861817
Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.
A study testing Laser theapy in people with Rhinosinusitis and Headache, run by Cairo University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Rhinosinusitis, Headache, Fatigue
- What is being tested?
- Laser theapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Jan 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients suffering from mild to moderate symptoms.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of physical therapy, Cairo university
Giza, Dokki, 12611
Olfat Ibrahim Ali
Giza, Dokki, 12611
About this study
Official title: Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.
Read the 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.
- Conditions
- Rhinosinusitis, Headache, Fatigue, CT
- Being tested
- Laser theapy
- Medical subject headings
- Rhinosinusitis, Headache, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month Receives: Device: Laser theapy |
| Control group | Sham comparator | using LLLT without output adjustment of the parameters Receives: Device: Laser theapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One month
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: One month
Ct finding
number of sinus opacifications before and after intervention.
Measured: Baseline
Ct finding
number of sinus opacifications before and after intervention.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start18 Jan 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olfat Ibrahim Ali, Cairo University
- Investigators
- Olfat I Ali, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861817
- Sponsor's protocol ID
- Chronic rhinosinusitis
- Acronym
- Sinusitis
- Status last verified
- May 2023
- First submitted
- 28 May 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38358423
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy on Headache, and Fatigue in Patients With Chronic Rhinosinusitis.
- ClinicalTrials.gov ID
- NCT05861817
- Acronym / sponsor ID
- Sinusitis / Chronic rhinosinusitis
- Conditions
- Rhinosinusitis, Headache, Fatigue, CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Laser theapyThe participants were treated using LLLT (904nm and 2.5 J/ sinus) for one month |
| Control group | Sham comparator | Device: Laser theapyusing LLLT without output adjustment of the parameters |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients suffering from mild to moderate symptoms.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser theapyparticipants 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 | Device | Control group, Study group |
Primary outcome
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
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
4 secondary outcomes
Fatigue
Time frame: Baseline
Fatigue
Time frame: One month
Ct finding
Time frame: Baseline
Ct finding
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 38358423Abdulrashid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olfat I Ali, PhD principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser theapy in people with Rhinosinusitis and Headache, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.