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

Primary Purpose

Bell's Palsy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prednisone and valacyclovir treatments
Magnetic and Oxygen Treatment
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring magnetic, oxygen, Bell's Palsy, acupuncture

Eligibility Criteria

10 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the 4th Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic - Oxygen

prednisone - valacyclovir

Arm Description

Magnetic and Oxygen Treatment for Bell's Palsy

prednisone and valacyclovir treatments for bell palsy

Outcomes

Primary Outcome Measures

House-Brackmann scale

Secondary Outcome Measures

Full Information

First Posted
August 28, 2012
Last Updated
September 12, 2012
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01686464
Brief Title
A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
Official Title
A New Clinical Therapy for Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy
Keywords
magnetic, oxygen, Bell's Palsy, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
882 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic - Oxygen
Arm Type
Experimental
Arm Description
Magnetic and Oxygen Treatment for Bell's Palsy
Arm Title
prednisone - valacyclovir
Arm Type
Active Comparator
Arm Description
prednisone and valacyclovir treatments for bell palsy
Intervention Type
Drug
Intervention Name(s)
prednisone and valacyclovir treatments
Other Intervention Name(s)
prednisone and valacyclovir
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic and Oxygen Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
House-Brackmann scale
Time Frame
the 20th day of completion of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yan L wang, Ph .D
Organizational Affiliation
Wenzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Li, M.D.
Organizational Affiliation
The 4th military medical university
Official's Role
Study Chair
Facility Information:
Facility Name
the 4th Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
7829945
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. doi: 10.1017/s0022215100128580.
Results Reference
result
PubMed Identifier
18368417
Citation
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.
Results Reference
result
Links:
URL
http://www.nlm.nih.gov/medlineplus/bellspalsy.html
Description
Bell palsy paralysis Acupuncture

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

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