RecruitingNCT04905745

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy

The Effectiveness and Safety of Integrative Korean Medicine Treatment for Bell's Palsy : A Prospective Observational Preliminary Study


Sponsor

Jaseng Medical Foundation

Enrollment

100 participants

Start Date

May 25, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study that evaluate the effectiveness and safety of Korean integrative treatments in patients with peripheral facial nerve palsy. Adulthood patients aged between 19 to 69 who were diagnosed with peripheral facial nerve palsy and receive Korean integrative treatments for facial palsy will be enrolled in the study and the change will be followed according to the Facial disability index (FDI) at the 3 month moment after baseline.


Eligibility

Min Age: 19 YearsMax Age: 69 Years

Inclusion Criteria4

  • age of 19 to 69
  • diagnosed with unilateral peripheral facial nerve palsy
  • onset of facial palsy within 3 weeks or less.
  • an individual who can provide written consent form to participate in the study.

Exclusion Criteria10

  • diagnosed with central nervous system disease causing facial palsy
  • secondary facial palsy after multiple sclerosis, tumor, cerebrovascular disease and temporal bone fracture.
  • Ramsay-Hunt syndrome
  • bilateral or recurrent facial nerve palsy.
  • an individual who received any treatment that can have a significant effect on changes in facial paralysis within recent 2 month. (ie. facial nerve decompression surgery)
  • already or planned to be pregnant or breast-feeding within the study period.
  • uncontrolled diabetes mellitus within the last 3 months.
  • within a month after participating any other facial palsy-related clinical trials, or planning to participate other clinical trials within 6 month.
  • impossible to read and understand the documents, regarding informed consent form and the questionnaires.
  • difficult to participate according to the judgement of researchers.

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Interventions

PROCEDUREKorean integrative medicine

Any kind of Korean integrative medicine will be applicable and the treatment will be entirely determined by experienced clinicians. On the premise of the above, the following examples are the treatments applicable to the subject of this observational study. * Chuna: Chuna therapy is performed on the face and cervical spine to induce decompression of the captured facial nerve. In addition, SJS Non-Resistance Technique-Facial palsy (SJS NRT-F), a technique of Chuna, can be performed to stimulate the intrinsic receptive sensation of the facial muscles to promote the neuromuscular response. * Acupuncture: acupuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Pharmacopuncture: pharmacopuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status. * Herbal medicine: It is prescribed according to clinical judgment according to the patient's symptoms and disease status.


Locations(1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

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NCT04905745


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