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A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
This study has been completed.
Sponsor:
Wenzhou Medical University
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
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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 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:
Further study details as provided by wang yanliang, Wenzhou Medical College:
Primary Outcome Measures:
- House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01686464
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:
Publications:
| Responsible Party: | wang yanliang, principal investigator, Wenzhou Medical College |
| ClinicalTrials.gov Identifier: | NCT01686464 History of Changes |
| Other Study ID Numbers: |
wykq2012 665533 ( Other Identifier: WZMC ) |
| Study First Received: | August 28, 2012 |
| Last Updated: | September 12, 2012 |
Keywords provided by wang yanliang, Wenzhou Medical College:
|
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 July 19, 2017