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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A New Clinical Therapy for Bell's Palsy

Conditions
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Bell's Palsy

Intervention / Treatment
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* Drug: prednisone and valacyclovir treatments
* Device: Magnetic and Oxygen Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic - Oxygen<br>Magnetic and Oxygen Treatment for Bell's Palsy | Device: Magnetic and Oxygen Treatment<br>* 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.<br>|
| Active Comparator: prednisone - valacyclovir<br>prednisone and valacyclovir treatments for bell palsy | Drug: prednisone and valacyclovir treatments<br>* 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.<br>* Other names: prednisone and valacyclovir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House-Brackmann scale |  | the 20th day of completion of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic, oxygen, Bell's Palsy, acupuncture