ClinicalTrials.gg
RecruitingNCT06986629Updated May 23, 2025

Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis

An interventional study of pulsed electromagnetic therapy and Photobiostimulation in Photobiostimulation, Pulsed Electromagnetic Filed and Low Level Laser Therapy, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Feb 2025, registered May 2025).
  • Started Feb 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Photobiostimulation
  • Pulsed Electromagnetic Filed
  • Low Level Laser Therapy
  • Chronic Rhinosinusitis (Diagnosis)
  • Quality of Life

Browse trials for

03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants suffering from mild to moderate symptoms (baseline Total nasal symptoms score ≤ 9).
  2. Subjects age range from 20 to 40 years old.
  3. Patients of both sexes.
  4. 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Patients with a definite deviated nasal septum, or history of operation within the last 6 months.
  • Hypertension, diabetes mellitus, , active pulmonary tuberculosis, active respiratory disease like asthma, or other systemic diseases.
  • Long-term use of or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    pulsed electromagnetic therapy

    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

    Device: pulsed electromagnetic therapy

  • Active comparator
    Photobiostimulation

    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

    Device: Photobiostimulation

  • Active comparator
    Self-sinus massage technique

    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

    Other: Self-sinus massage technique

Interventions

  • Devicepulsed electromagnetic therapy

    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.

  • DevicePhotobiostimulation

    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

  • OtherSelf-sinus massage technique

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at baseline and after 8 weeks

Secondary outcomes

  1. 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.

    Time frame: at baseline and after 8 weeks

  2. assessment of change of Mean platelet volume

    Venous blood samples will be drawn to assess and calculate the average volume of individual platelets

    Time frame: at baseline and after 8 weeks

  3. assessment of change of white blood cells count

    Venous blood samples will be drawn to assess and calculate the white blood cells count

    Time frame: at baseline and after 8 weeks

  4. 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)

    Time frame: at baseline and after 8 weeks

  5. 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

    Time frame: at baseline and after 8 weeks

07

Study locations

1 of 1 sites recruiting
  • out-patient clinic, faculty of physical therapy, October University for Modern Sciences and Arts
    Cairo, Egypt
    Recruiting
    • Samar Said October University for Modern Sciences and Arts, physical therapist · Contactsamar.said.alfiqy@gmail.com · +201156644369
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2025 (actual). Primary completion is estimated for Jul 2025, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2025
First posted
May 23, 2025
StartActual
Feb 1, 2025
Primary completionEst.
Jul 1, 2025
CompletionEst.
Aug 1, 2025
Last update
May 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06986629
Lead sponsor
Cairo University
Responsible party
Samar Said Abd Al-Razek Abd Al-Fattah (principal investigator, Cairo University) — Principal investigator
First posted
May 23, 2025
Start date
Feb 1, 2025
Primary completion
Jul 1, 2025 (estimated)
Completion
Aug 1, 2025 (estimated)
Last update
May 23, 2025

Study contacts

Samar Said Abd AL-razek, physical therapist
Contact
samar.said.alfiqy@gmail.com
+201156644369

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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