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Study on Estimating Acupuncture Treatment Effects using Facial Muscle Contraction Response and the Yanagihara Score

A Retrospective Study on Estimating Acupuncture Treatment Effects for Peripheral Facial Nerve Palsy Using Electroacupuncture-Induced Facial Muscle Contraction Response and the Yanagihara Score - EAFaY Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057695
Enrollment
175
Registered
2025-04-23
Start date
2024-05-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with peripheral facial palsy

Interventions

None listed

Sponsors

Saitama Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactGo Horibe

Saitama Medical University Hospital Department of Oriental Medicine

ghoribe@saitama-med.ac.jp049-276-2108

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026