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Completed

NCT Number: NCT05865613

Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

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

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo university

Giza, Dokki, 12611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed electromagnetic field

Device

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

Primary outcomes

  1. Headache

    Time frame: 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 outcomes

  1. Fatigue

    Time frame: 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

    Time frame: Baseline and one month.

    Number of sinus opacifications before and after intervention.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 19, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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