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Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

Primary Purpose

Magnetic Therapy, Rhinosinusitis, Headache

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulsed electromagnetic field
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Magnetic Therapy

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of physical therapy, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Magnetic group

Sham magnetic group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
CT finding
Number of sinus opacifications before and after intervention.

Full Information

First Posted
June 27, 2022
Last Updated
May 9, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05865613
Brief Title
Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.
Official Title
Effect of Pulsed Electromagnetic Field Therapy on Headache, Fatigue, and CT Finding on Patients With Chronic Rhinosinusitis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Therapy, Rhinosinusitis, Headache, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham magnetic group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pulsed electromagnetic field
Other Intervention Name(s)
Sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache
Description
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.
Time Frame
Baseline and one month.
Secondary Outcome Measure Information:
Title
Fatigue
Description
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
Time Frame
Baseline and one month.
Title
CT finding
Description
Number of sinus opacifications before and after intervention.
Time Frame
Baseline and one month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of physical therapy, Cairo university
City
Giza
State/Province
Dokki
ZIP/Postal Code
12611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

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