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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
wang yanliang, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01686464
First received: August 28, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Bell's Palsy
 Drug: prednisone and valacyclovir treatments
Device: Magnetic and Oxygen Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A New Clinical Therapy for Bell's Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ] [ Designated as safety issue: No ]

Enrollment: 882
Study Start Date: June 1998
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic - Oxygen
Magnetic and Oxygen Treatment for Bell's Palsy
 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.
Active Comparator: prednisone - valacyclovir
prednisone and valacyclovir treatments for bell palsy
 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 Name: prednisone and valacyclovir

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.

  Eligibility

Ages Eligible for Study:   10 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686464

Locations
China, Shanxi
the 4th Military Medical University
Xi'an, Shanxi, China, 710000
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: yan L wang, Ph .D Wenzhou Medical University
Study Chair: Ping Li, M.D. The 4th military medical university
  More Information

Additional Information:
Bell palsy paralysis Acupuncture  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: wang yanliang, principal investigator, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01686464     History of Changes
Other Study ID Numbers: wykq2012, 665533
Study First Received: August 28, 2012
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wenzhou Medical University:
magnetic
oxygen
Bell's Palsy
acupuncture

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Prednisone
 Valacyclovir
Acyclovir
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 18, 2013