Effect of Electromagnetic Therapy on Patients With Chronic Rhinosinusitis.

NCT05865613 | Completed DMC

• 1 other identifier: magnetic and rhinosinusitis
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Therapy; Rhinosinusitis; Headache; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fatigue

  Baseline and one month.

• CT finding

  Baseline and one month.

Study Arms (2)

Magnetic group

EXPERIMENTAL

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

Sham magnetic group

SHAM COMPARATOR

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

Interventions

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.

Also known as: Sham

Magnetic group; Sham magnetic group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients suffering from mild to moderate symptoms of rhinosinusitis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo university

Giza, Dokki, 12611, Egypt

Location

MeSH Terms

Conditions

Rhinosinusitis; Headache; Fatigue

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: May 19, 2023
• Study Start: June 15, 2023
• Primary Completion: January 11, 2024
• Study Completion: January 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)