UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057695 |
|---|---|
| Receipt number | R000065561 |
| Scientific Title | A Retrospective Study on Estimating Acupuncture Treatment Effects for Peripheral Facial Nerve Palsy Using Electroacupuncture-Induced Facial Muscle Contraction Response and the Yanagihara Score |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2026/03/25 15:18:15 |
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Basic information
Public title
Study on Estimating Acupuncture Treatment Effects using Facial Muscle Contraction Response and the Yanagihara Score
Acronym
EAFaY Study
Scientific Title
A Retrospective Study on Estimating Acupuncture Treatment Effects for Peripheral Facial Nerve Palsy Using Electroacupuncture-Induced Facial Muscle Contraction Response and the Yanagihara Score
Scientific Title:Acronym
EAFaY Study
Region
| Japan |
Condition
Condition
patients with peripheral facial palsy
Classification by specialty
| Neurology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to estimate the therapeutic effects of acupuncture in patients with acute peripheral facial palsy (FP) by classifying them into groups based on differences in facial muscle contraction responses (FMCR) induced by electroacupuncture stimulation and the Yanagihara score, a commonly used facial palsy assessment tool.
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two predictive models will be constructed in this study. Model 1 will classify patients into groups based solely on the facial muscle contraction response (FMCR), whereas Model 2 will classify patients into groups based on both the FMCR and the Yanagihara score. Within each model, hazard ratios for achieving the predefined recovery criteria will be estimated for each group. In addition, time-dependent area under the curve (AUC) values at 30, 90, 180, and 360 days after onset will be calculated and compared between the two models using the modified DeLong test, with Holm's procedure applied to adjust for multiple comparisons.
Key secondary outcomes
Differences in electroneurography (ENoG) values between Model 1 and Model 2 will also be examined.
In addition, hazard ratios for achieving the predefined recovery criteria will be estimated for comparisons among groups within each model: Model 1, Model 2, and Model 3 will classify patients into groups based on both electroneurography (ENoG) values and the Yanagihara score. Model 4 will classify patients into groups based on the Yanagihara score. Model 5 will classify patients into groups based on ENoG values alone. Hazard ratios for achieving the predefined recovery criteria will be estimated for comparisons among groups within each model. In addition, time-dependent AUC values at 30, 90, 180, and 360 days after onset will be calculated and compared using the modified DeLong test, with Holm's procedure applied to adjust for multiple comparisons
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with peripheral facial palsy who received acupuncture treatment at the Department of Oriental Medicine, Saitama Medical University Hospital between June 1, 2016, and December 31, 2023.
(Acupuncture treatments included electroacupuncture near the affected facial nerve and needling of the facial muscles.)
2.Patients within two weeks of onset.
3.Patients who underwent ENoG using the modified NLF method.
4.Patients whose FMCR results were recorded in the electronic medical record.
5.Patients whose Yanagihara scores within two weeks of onset were recorded in the electronic medical record.
Key exclusion criteria
1.Patients with a history of either central or peripheral facial nerve palsy.
2.Patients with unknown onset date, medical history, or medication history.
3.Patients without a confirmed diagnosis of the cause of peripheral facial palsy (e.g., insufficient differential diagnosis to conclude Bell's palsy).
4.Patients with ENoG values equal to or greater than 100%.
5.Patients who underwent ENoG more than two weeks after onset.
6.Patients who expressed a desire to be excluded from the study.
Target sample size
175
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Horibe |
Organization
Saitama Medical University Hospital
Division name
Department of Oriental Medicine, Department of Neurology
Zip code
350-495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-2108
ghoribe@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Horibe |
Organization
Saitama Medical University Hospital
Division name
Department of Oriental Medicine
Zip code
350-0495
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-2108
Homepage URL
ghoribe@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Go Horibe
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Saitama Medical University Hospital
Address
Morohongo 38, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-1354
horibe.go@1972.saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2024 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065561
