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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05865613
Other study ID # magnetic and rhinosinusitis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date March 2, 2023

Study information

Verified date May 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to evaluate the efficacy of Pulsed electromagnetic field (PEMF) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.


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, sleep quality, and daily productivity. A pulsed electromagnetic field (PEMF) has an anti-inflammatory, antimicrobial, and improves the microcirculation of the mucosal membrane of the nasal cavity. It has been suggested that magnetic therapy can be used in treating chronic sinusitis but there is a scarce of studies about its usage.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - patients suffering from mild to moderate symptoms of rhinosinusitis. Exclusion Criteria: - pregnant or breastfeeding women. - patients with 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 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 within 2 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 which the researchers believed were inappropriate.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulsed electromagnetic field
Participants were randomized into either the PEMF group or sham treatment group by a computer-generated random number. The participants were treated using PEMF (20 G ,7H for 10min) and sham treatment. treatment was delivered for one month.

Locations

Country Name City State
Egypt Faculty of physical therapy, Cairo university Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Headache Headache was measured using VAS at the beginning and end of the intervention. The scale ranged from zero to 10. The higher the scale the higher the headache. Baseline and one month.
Secondary 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 Baseline and one month.
Secondary CT finding Number of sinus opacifications before and after intervention. Baseline and one month.
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