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Completed

NCT Number: NCT01686464

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

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.

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Key information

Age range

10 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the 4th Military Medical University

Xi’an, Shanxi, 710000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prednisone and valacyclovir treatments

Drug

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 names: prednisone and valacyclovir

Magnetic and Oxygen Treatment

Device

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.

Primary outcomes

  1. House-Brackmann scale

    Time frame: the 20th day of completion of the treatment

Sponsors and collaborators

Lead sponsor

Wenzhou Medical University

Other

Registry information

Official study title

A New Clinical Therapy for Bell's Palsy

Important dates

Study start
1998
Primary completion
2005
Study completion
2005
First posted
Sep 18, 2012
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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