Clinical trial NCT01686464: A Clinical Study on the Combined Magnetic and Oxygen Treatment for Bell's Palsy
Official title: A New Clinical Therapy for Bell's Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bell's Palsy
Keywords: magnetic
oxygen
Bell's Palsy
acupuncture
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 882
Sex: ALL
Minimum age (years): 10
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: House-Brackmann scale
timeFrame: the 20th day of completion of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the 4th Military Medical University
state: Shanxi
Study officials:
affiliation: Wenzhou Medical University
name: yan L wang, Ph .D
role: PRINCIPAL_INVESTIGATOR
affiliation: The 4th military medical university
name: Ping Li, M.D.
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1017/s0022215100128580.
citation: 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.