A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01686464 |
|
Recruitment Status :
Completed
First Posted : September 18, 2012
Last Update Posted : September 18, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bell's Palsy | Drug: prednisone and valacyclovir treatments Device: Magnetic and Oxygen Treatment | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 882 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A New Clinical Therapy for Bell's Palsy |
| Study Start Date : | June 1998 |
| Actual Primary Completion Date : | January 2005 |
| Actual Study Completion Date : | January 2005 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 10 Years to 74 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications of Results:
| Responsible Party: | wang yanliang, principal investigator, Wenzhou Medical University |
| ClinicalTrials.gov Identifier: | NCT01686464 History of Changes |
| Other Study ID Numbers: |
wykq2012 665533 ( Other Identifier: WZMC ) |
| First Posted: | September 18, 2012 Key Record Dates |
| Last Update Posted: | September 18, 2012 |
| Last Verified: | September 2012 |
Keywords provided by wang yanliang, 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 |