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

Not Applicable

Completed

• Conditions: Bell's Palsy
• Interventions: Device: Magnetic and Oxygen Treatment; Drug: prednisone and valacyclovir treatments

• Registration Number: NCT01686464
• Lead Sponsor: Wenzhou Medical University

Brief 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.

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2012-08-28
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-12
• Last Update Submitted: 2012-09-12
• Study First Posted: 2012-09-18
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 882

Inclusion Criteria

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

Exclusion Criteria

1. facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
2. facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
3. patient with Hunt's syndrome
4. pregnant women or women in lactation
5. patients are participating other clinical research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic - Oxygen	Magnetic and Oxygen Treatment	Magnetic and Oxygen Treatment for Bell's Palsy
prednisone - valacyclovir	prednisone and valacyclovir treatments	prednisone and valacyclovir treatments for bell palsy

Primary Outcome Measures

Name	Time	Method
House-Brackmann scale	the 20th day of completion of the treatment

Trial Locations

Locations (1)

the 4th Military Medical University; 🇨🇳 Xi'an, Shanxi, China