NCT01686464

A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy

A New Clinical Therapy for Bell's Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 882 (actual)
• Sponsor: Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 10 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinic trial is to testify the efficacy of using new and noninvasive therapy, called simultaneous "Magnetic and Oxygen Treatment along Meridians and Collaterals" (MOMC), to treat Bell's Palsy.

Detailed description

Between June 1998 and January 2005, a total of 3002 subjects with BP were evaluated, 882 patients fulfilled the inclusion criteria and entered the study. Patients were randomly assigned to either the prednisone-valacyclovir group(group 1) or the magnetic-oxygen group(group 2) . Among the 882 patients completing the study,825 patients in group 1 received prednisone, given as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days. 57 patients in group 2 received magnetic-oxygen treatment:MOMC treatment was given as daily 20 min section for 10 days with 2\~3 days of intermission between;Oxygen therapy was given simultaneously at a flow rate of 2\~3.0 L / min for the same duration during all acupuncture sections. Clinical evaluation for the severity of paralysis was performed immediately before and after the treatment using the facial nerve grading (FNG) scores of House and Brackmann system.

Conditions

• Bell's Palsy

Interventions

Type	Name	Description
DRUG	prednisone and valacyclovir treatments	patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.
DEVICE	Magnetic and Oxygen Treatment	MOMC treatment was given as daily 20 min section for 10 days with 2\~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2\~3.0 L / min for the same duration during all acupuncture sections.

Timeline

• Start date: 1998-06-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2012-09-18
• Last updated: 2012-09-18

Locations

1 site across 1 country: China