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

Bell's Palsy Clinical Trial

Official title:

A New Clinical Therapy for Bell's Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686464
• Other study ID #: wykq2012
• Secondary ID: 665533
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: September 12, 2012
• Start date: June 1998
• Est. completion date: January 2005

Study information

• Verified date: September 2012
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 882
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Paralysis

Intervention

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.

Locations

Country	Name	City	State
China	the 4th Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Finsterer J. Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):743-52. doi: 10.1007/s00405-008-0646-4. Epub 2008 Mar 27. Review. — View Citation

Shafshak TS, Essa AY, Bakey FA. The possible contributing factors for the success of steroid therapy in Bell's palsy: a clinical and electrophysiological study. J Laryngol Otol. 1994 Nov;108(11):940-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House-Brackmann scale		the 20th day of completion of the treatment	No

External Links

•   Bell palsy paralysis Acupuncture