Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

Fatigue Clinical Trial

Official title:

Effect of Pulsed Electromagnetic Field Therapy on Headache, Fatigue, and CT Finding on Patients With Chronic Rhinosinusitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865613
• Other study ID #: magnetic and rhinosinusitis
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fatigue
• Headache
• Rhinosinusitis
• Sinusitis

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.