PhotobiostimulationNCT06986629
Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis
A study testing pulsed electromagnetic therapy, Photobiostimulation and Self-sinus massage technique in people with Photobiostimulation and Pulsed Electromagnetic Filed, run by Cairo University at 1 site in Egypt.
Trial summary
This study was done to find out the effect of photobiostimulation and pulsed electromagnetic field in patients with chronic rhinosinusitis on: Quality of life. Pulmonary function. Mean platelet volume. headache . total nasal symptoms. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Photobiostimulation, Pulsed Electromagnetic Filed, Low Level Laser Therapy
- What is being tested?
- pulsed electromagnetic therapy, Photobiostimulation and Self-sinus massage technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants suffering from mild to moderate symptoms (baseline Total nasal symptoms score ≤ 9).
- Subjects age range from 20 to 40 years old.
- Patients of both sexes.
- proven positive allergy test (skin prick test or multiple allergen simultaneous test) to any of the common perennial allergens such as dust mites, molds, insects, and animal dander within the last 12 months
Who cannot join
- Pregnant or breastfeeding women.
- Patients with a definite deviated nasal septum, or history of operation within the last 6 months.
- Hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, active respiratory disease like asthma, or other systemic diseases.
- Long-term use of corticosteroids or immunosuppressive agents.
- Participation in another clinical study within 30 days.
- Hyperthyroidism
- Patients who had used antihistamines within 1 week, topical corticosteroids within 2 weeks, systemic corticosteroids within 4 weeks, anticholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, nonsteroidal analgesics within 2 weeks, and other drugs that the researchers believed were inappropriate.
- Patients with Tattoos, moles and dark skin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
out-patient clinic, faculty of physical therapy, October University for Modern Sciences and Arts
Cairo
Samar Said October University for Modern Sciences and Arts, physical therapist, +201156644369, samar.said.alfiqy@gmail.com
About this study
This study was done to find out the effect of photobiostimulation and pulsed electromagnetic field in patients with chronic rhinosinusitis on:
- Quality of life.
- Pulmonary function.
- Mean platelet volume.
- headache .
- total nasal symptoms.
Read the detailed description
Chronic rhinosinusitis is a severe disease that significantly impacts a patient's quality of life, leading to significant economic impacts on healthcare resources and absenteeism. Symptoms interfere with daily activities and can lead to medication resistance. Treatment options like steroids, oral antibiotics, and sinus surgery are less effective, and disease recurrence remains high even after surgery. Alternative therapies like low-level laser therapy and pulsed electromagnetic filed have shown promise in improving symptoms and potentially making low-level laser therapy a non-invasive treatment for Chronic rhinosinusitis
- Conditions
- Photobiostimulation, Pulsed Electromagnetic Filed, Low Level Laser Therapy, Chronic Rhinosinusitis (Diagnosis), Quality of Life
- Being tested
- pulsed electromagnetic therapy, Photobiostimulation, Self-sinus massage technique
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed electromagnetic therapyDevice
We will use the ASTAR Physio MG 827, a generator and 75 cm solenoid couch, in a pulsed electromagnetic field group. Participants will be placed comfortably in the solenoid, and the device will be turned on and programmed for 20 guesses for 10 minutes, 7 Hz, three times per week for 8 weeks.
PhotobiostimulationDevice
The therapy will be performed using an ASTAR PhysioGo -As low level laser therapy device with a wavelength of 830 nm, 30 mW power output, and 1 J energy dose. Patients will be supine and wear laser safety goggles. The laser will be applied to six locations over the maxillary or frontal sinuses, administered in a continuous manner for 33 seconds per spot, totaling 198 seconds and 6 J per session
Self-sinus massage techniqueOther
Participants are instructed to perform self-massage to their frontal and maxillary sinuses at home twice daily, in the morning and evening. For the frontal sinus, place the fingers above the eyebrows on either side of the forehead, and gently circular outward massage for three sets of 30 seconds, repeated twice a day.
| Study group | Role | What they receive |
|---|---|---|
| pulsed electromagnetic therapy | Experimental | This group included twenty adults with chronic rhinosinusitis and received pulsed electromagnetic therapy. This treatment protocol will be carried out three times per week for 8 weeks Receives: Device: pulsed electromagnetic therapy |
| Photobiostimulation | Active comparator | This group included twenty adults with chronic rhinosinusitis and received low level laser therapy. This treatment protocol will be carried out three times per week for 8 weeks Receives: Device: Photobiostimulation |
| Self-sinus massage technique | Active comparator | This group included twenty adults with chronic rhinosinusitis and received the self-sinus massage technique only. This treatment protocol will be carried out three times per week for 8 weeks Receives: Other: Self-sinus massage technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of change of quality of life
The Sinonasal Outcome Test-22 questionnaire is a commonly used tool in clinical practice to assess patients' quality of life with chronic respiratory syndrome. It consists of 22 chronic respiratory syndrome-related items, ranging from 0 to 5, and categorizes them into physical symptoms (items 1-12) and health and quality of life (items 13-22), covering sleep function and psychological difficulties. It is easy to understand and complete.
Measured: at baseline and after 8 weeks
Secondary outcomes (5)
assessment of change of pulmonary functions
The Global Initiative for Chronic Obstructive Lung Disease 2010 guidelines outline a procedure for a spirometer. The patient is instructed to breathe in until their lungs feel full, then hold their breath tightly around the mouthpiece. The operator blasts the air out forcefully, encouraging the patient to continue. The procedure is repeated twice until three repeatable blows are obtained, with the best two readings within 150 mL or 5% of each other.
Measured: at baseline and after 8 weeks
assessment of change of Mean platelet volume
Venous blood samples will be drawn to assess and calculate the average volume of individual platelets
Measured: at baseline and after 8 weeks
assessment of change of white blood cells count
Venous blood samples will be drawn to assess and calculate the white blood cells count
Measured: at baseline and after 8 weeks
assessment of change of headache pain severity
It will be used to evaluate headache pain severity using a standard horizontal scale as mild (1-3 on a visual analogue scale), moderate (4-6 on a visual analogue scale), severe (7-9 on a visual analogue scale) and very severe (10 on a visual analogue scale)
Measured: at baseline and after 8 weeks
assessment of change of total nasal symptoms
It is the sum of scores for nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four-point scale (0-3). A score of 0 indicates no symptoms, a score of 1 indicates mild symptoms that are easily tolerated, a score of 2 indicates awareness of bothersome but tolerable symptoms, and a score of 3 indicates severe symptoms that interfere with daily activities. The total nasal symptoms scale is calculated by combining the scores for each symptom to a total of 12
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Feb 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiostimulationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Said Abd Al-Razek Abd Al-Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986629
- Sponsor's protocol ID
- Samar-005562
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT06986629
- Acronym / sponsor ID
- Samar-005562
- Conditions
- Photobiostimulation, Pulsed Electromagnetic Filed, Low Level Laser Therapy, Chronic Rhinosinusitis (Diagnosis), Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 May 2025 (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 was done to find out the effect of photobiostimulation and pulsed electromagnetic field in patients with chronic rhinosinusitis on:
- Quality of life.
- Pulmonary function.
- Mean platelet volume.
- headache .
- total nasal symptoms.
Detailed description
Chronic rhinosinusitis is a severe disease that significantly impacts a patient's quality of life, leading to significant economic impacts on healthcare resources and absenteeism. Symptoms interfere with daily activities and can lead to medication resistance. Treatment options like steroids, oral antibiotics, and sinus surgery are less effective, and disease recurrence remains high even after surgery. Alternative therapies like low-level laser therapy and pulsed electromagnetic filed have shown promise in improving symptoms and potentially making low-level laser therapy a non-invasive treatment for Chronic rhinosinusitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pulsed electromagnetic therapy | Experimental | Device: pulsed electromagnetic therapyThis group included twenty adults with chronic rhinosinusitis and received pulsed electromagnetic therapy. This treatment protocol will be carried out three times per week for 8 weeks |
| Photobiostimulation | Active comparator | Device: PhotobiostimulationThis group included twenty adults with chronic rhinosinusitis and received low level laser therapy. This treatment protocol will be carried out three times per week for 8 weeks |
| Self-sinus massage technique | Active comparator | Other: Self-sinus massage techniqueThis group included twenty adults with chronic rhinosinusitis and received the self-sinus massage technique only. This treatment protocol will be carried out three times per week for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants suffering from mild to moderate symptoms (baseline Total nasal symptoms score ≤ 9).
- Subjects age range from 20 to 40 years old.
- Patients of both sexes.
- proven positive allergy test (skin prick test or multiple allergen simultaneous test) to any of the common perennial allergens such as dust mites, molds, insects, and animal dander within the last 12 months
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women.
- Patients with a definite deviated nasal septum, or history of operation within the last 6 months.
- Hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, active respiratory disease like asthma, or other systemic diseases.
- Long-term use of corticosteroids or immunosuppressive agents.
- Participation 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 |
|---|---|---|
| pulsed electromagnetic therapyWe will use the ASTAR Physio MG 827, a generator and 75 cm solenoid couch, in a pulsed electromagnetic field group. Participants will be placed comfortably in the solenoid, and the device will be turned on and programmed for 20 guesses for 10 minutes, 7 Hz, three times per week for 8 weeks. | Device | pulsed electromagnetic therapy |
| PhotobiostimulationThe therapy will be performed using an ASTAR PhysioGo -As low level laser therapy device with a wavelength of 830 nm, 30 mW power output, and 1 J energy dose. Patients will be supine and wear laser safety goggles. The laser will be applied to six locations over the maxillary or frontal sinuses, administered in a continuous manner for 33 seconds per spot, totaling 198 seconds and 6 J per session | Device | Photobiostimulation |
| Self-sinus massage techniqueParticipants are instructed to perform self-massage to their frontal and maxillary sinuses at home twice daily, in the morning and evening. For the frontal sinus, place the fingers above the eyebrows on either side of the forehead, and gently circular outward massage for three sets of 30 seconds, repeated twice a day. | Other | Self-sinus massage technique |
Primary outcome
assessment of change of quality of life
Time frame: at baseline and after 8 weeks
The Sinonasal Outcome Test-22 questionnaire is a commonly used tool in clinical practice to assess patients' quality of life with chronic respiratory syndrome. It consists of 22 chronic respiratory syndrome-related items, ranging from 0 to 5, and categorizes them into physical symptoms (items 1-12) and health and quality of life (items 13-22), covering sleep function and psychological difficulties. It is easy to understand and complete.
5 secondary outcomes
assessment of change of pulmonary functions
Time frame: at baseline and after 8 weeks
assessment of change of Mean platelet volume
Time frame: at baseline and after 8 weeks
assessment of change of white blood cells count
Time frame: at baseline and after 8 weeks
assessment of change of headache pain severity
Time frame: at baseline and after 8 weeks
assessment of change of total nasal symptoms
Time frame: at baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed electromagnetic therapy, Photobiostimulation and Self-sinus massage technique in people with Photobiostimulation and Pulsed Electromagnetic Filed, run by Cairo University at 1 site 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Said Abd AL-razek, physical therapist (+201156644369, samar.said.alfiqy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of change of quality of life (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.