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

• ClinicalTrials.gov Identifier: NCT01686464
• Recruitment Status: Completed
• First Posted: September 18, 2012
• Last Update Posted: September 18, 2012
• Sponsor: Wenzhou Medical University
• Information provided by (Responsible Party): wang yanliang, Wenzhou Medical University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Bell's Palsy	Drug: prednisone and valacyclovir treatments; Device: Magnetic and Oxygen Treatment	Not Applicable

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. House-Brackmann scale [ Time Frame: the 20th day of completion of the treatment ]

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 74 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 

Publications of Results:

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 University
• ClinicalTrials.gov Identifier: NCT01686464 History of Changes
• Other Study ID Numbers: wykq2012; 665533 ( Other Identifier: WZMC )
• First Posted: September 18, 2012
• 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:

Bell Palsy; Facial Paralysis; 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; Valacyclovir; Prednisone; 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