Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

Not Applicable

Completed

• Conditions: Magnetic Therapy; Rhinosinusitis; Fatigue; Headache
• Interventions: Device: Pulsed electromagnetic field

• Registration Number: NCT05865613
• Lead Sponsor: Cairo University

Brief Summary

This study aimed to evaluate the efficacy of Pulsed electromagnetic field (PEMF) 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, 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.

Study Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-19
• Study Start: 2023-06-15
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic group	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). treatment was delivered for one month.
Sham magnetic group	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 without adjusting the output. treatment was delivered for one month.

Primary Outcome Measures

Name	Time	Method
Headache	Baseline and one month.	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.

Secondary Outcome Measures

Name	Time	Method
Fatigue	Baseline and one month.	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
CT finding	Baseline and one month.	Number of sinus opacifications before and after intervention.

Trial Locations

Locations (1)

Faculty of physical therapy, Cairo university; 🇪🇬 Giza, Dokki, Egypt