A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
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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 |
- 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.
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|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01686464
| China, Shanxi | |
| the 4th Military Medical University | |
| Xi'an, Shanxi, China, 710000 | |
| 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:
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 Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Signs and Symptoms Stomatognathic Diseases Virus Diseases |
Prednisone Valacyclovir Anti-Infective Agents Anti-Inflammatory Agents Antineoplastic Agents Antineoplastic Agents, Hormonal Antiviral Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015