A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy - Full Text View

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:

MedlinePlus related topics: Bell's Palsy Oxygen Therapy Paralysis Steroids

Drug Information available for: Prednisone Valacyclovir Valacyclovir hydrochloride

Genetic and Rare Diseases Information Center resources: Bell's Palsy

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 (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.

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.


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:


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

ClinicalTrials.gov processed this record on September 26, 2016