Trial | NCT01686464  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    882
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.
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.
Study Started
Jun 30
1998
Primary Completion
Jan 31
2005
Study Completion
Jan 31
2005
Last Update
Sep 18
2012
Estimate

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 names: prednisone and valacyclovir

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.

Magnetic - Oxygen Experimental

Magnetic and Oxygen Treatment for Bell's Palsy

prednisone - valacyclovir Active Comparator

prednisone and valacyclovir treatments for bell palsy

Criteria 

Inclusion Criteria:

Only patients with complete (or nearly complete) non-recurrent facial paralysis (grade 5-6/6) for more than 1 months
the first time to onset the disease
on one side of the face paralysis
willing to finish the whole observation period
with written consent form signed by themselves.

Exclusion Criteria:

facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
patient with Hunt's syndrome
pregnant women or women in lactation
patients are participating other clinical research
No Results Posted