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

NCT ID: NCT01686464

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Study Completion Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bell's Palsy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

magnetic oxygen Bell's Palsy acupuncture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Magnetic - Oxygen

Magnetic and Oxygen Treatment for Bell's Palsy

Group Type EXPERIMENTAL

Magnetic and Oxygen Treatment

Intervention Type 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.

prednisone - valacyclovir

prednisone and valacyclovir treatments for bell palsy

Group Type ACTIVE_COMPARATOR

prednisone and valacyclovir treatments

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

prednisone and valacyclovir

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

wang yanliang

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yan L wang, Ph .D

Role: PRINCIPAL_INVESTIGATOR

Wenzhou Medical University

Ping Li, M.D.

Role: STUDY_CHAIR

The 4th military medical university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the 4th Military Medical University

Xi’an, Shanxi, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 7829945 (View on PubMed)

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.

Reference Type RESULT
PMID: 18368417 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

665533

Identifier Type: OTHER

Identifier Source: secondary_id

wykq2012

Identifier Type: -

Identifier Source: org_study_id