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Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05865613
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
14.5
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pulsed electromagnetic field
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Pulsed Electromagnetic Field Therapy on Headache, Fatigue, and CT Finding on Patients With Chronic Rhinosinusitis.
Actual Study Start Date :
Dec 15, 2021
Actual Primary Completion Date :
Mar 2, 2023
Actual Study Completion Date :
Mar 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Magnetic group

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.

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.
Other Names:
  • Sham

    		•
    Sham Comparator: Sham magnetic group

    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.

    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.
    Other Names:
  • Sham

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. CT finding [Baseline and one month.]

      Number of sinus opacifications before and after intervention.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of physical therapy, Cairo university Giza Dokki Egypt 12611

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olfat Ibrahim Ali, Assistant Professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05865613
    Other Study ID Numbers:
    • magnetic and rhinosinusitis
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sinusitis
    Fatigue
    Headache

    Study Results

    No Results Posted as of May 19, 2023