A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
|Bell's Palsy||Drug: prednisone and valacyclovir treatments Device: Magnetic and Oxygen Treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A New Clinical Therapy for Bell's Palsy|
- House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ]
|Study Start Date:||June 1998|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
Experimental: Magnetic - Oxygen
Magnetic and Oxygen Treatment for Bell's Palsy
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.
Active Comparator: prednisone - valacyclovir
prednisone and valacyclovir treatments for bell palsy
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.
Other Name: prednisone and valacyclovir
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686464
|the 4th Military Medical University|
|Xi'an, Shanxi, China, 710000|
|Principal Investigator:||yan L wang, Ph .D||Wenzhou Medical University|
|Study Chair:||Ping Li, M.D.||The 4th military medical university|