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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-69
SponsorJaseng Medical Foundation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

adulthood male and female patients with peripheral facial nerve palsy

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Korean integrative medicine

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Facial palsy1 intervention

Trial outcomes

Primary outcomes

1

Facial disability index

This is a questionnaire made to evaluate the subjective sensations of patients on the ability to use facial muscles and their emotional state. It is composed of 10 items, and 1-5 is composed of 5 points per item for movement state, and 6-10 is composed of 6 points per item for sociological state and emotional state.

Time frame
week 14

Secondary outcomes

1

Facial disability index (FDI)

This is a questionnaire made to evaluate the subjective sensations of patients on the ability to use facial muscles and their emotional state. It is composed of 10 items, and 1-5 is composed of 5 points per item for movement state, and 6-10 is composed of 6 points per item for sociological state and emotional state.

Time frame
week 1, 5, 14, 53
2

House-Brackmann facial palsy grade system (HB grade)

HB grade is a scale to evaluate facial palsy into 6 stages based on the severity of facial palsy, especially the muscles around the mouth and the muscles arount the eyes.

Time frame
week 1, 5, 14, 53 and every week during treatment (for survival analysis in complete recovery)
3

Numeric rating scale (NRS)

NRS is a 11-point scale of 0-10. the researcher will rate NRS for postauricular pain and discomforts in the face and cervical area.

Time frame
week 1, 5, 14, 53 and every week during treatment
4

Facial nerve grading system (FNGS 2.0)

FNGS 2.0 is calculated based on the total score by section by section in facial part and additional score with synkinesis movement. The result of FNGS 2.0 well indicate the palsy status, with the grade of 1-6 and 4-24 points.

Time frame
week 1, 5, 14, 53

Other outcomes

Sponsors and contacts

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