NCT06573697

Brief Summary

Bell palsy (BP) is a relatively common clinical disease, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture received attention in the management of BP. The aim of this study is to evaluate the curative effect of different waveform of electroacupuncture on peripheral facial paralysis in subacute stage and to screen out the optimal waveform.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

November 25, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

August 24, 2024

Last Update Submit

November 21, 2024

Conditions

Bell Palsy

Keywords

Bell palsyPeripheral facial paralysisClinical studyAcupuncture treatment

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0)

    Evaluation of the facial nerve function using the Facial Nerve Grading System 2.0 (FNGS 2.0). In the FNGS 2.0, the minimal score is 4, which indicates normal function, and the maximal score is 24, which indicates the worst function.

    Baseline,4 weeks

Secondary Outcomes (3)

  • Change from Baseline score of the Sunnybrook grading(SFGS) scale

    Baseline,4 weeks

  • Change from Baseline score of the Facial Disability Index(FDI)

    Baseline,4 weeks

  • Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test.

    Baseline

Study Arms (3)

low-frequency continuous wave group

EXPERIMENTAL

In each treatment session, the patients will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2Hz continuous wave will be used for 20 min.

Other: low-frequency continuous wave EA

discontinuous wave group

EXPERIMENTAL

In each treatment session, the patientss will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 40Hz discontinuous wave will be used for 20 min.

Other: discontinuous wave EA

dilatational wave group

EXPERIMENTAL

In each treatment session, the patientss will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2/100Hz dilatational wave will be used for 20 min.

Other: dilatational wave EA

Interventions

low-frequency continuous wave EAOTHER

In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2Hz continuous wave will be used for 20 min.

low-frequency continuous wave group
discontinuous wave EAOTHER

In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 40Hz discontinuous wave will be used for 20 min.

discontinuous wave group
dilatational wave EAOTHER

In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2/100Hz dilatational wave will be used for 20 min.

dilatational wave group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients meet the clinical classification criteria for BP, diagnosed by specialist.
  • weeks from onset.
  • Male or female patients aged 18-65 years.
  • FNGS2.0≥4
  • Clearly aware, able to complete normal communication, signed informed consent.

You may not qualify if:

  • Facial paralysis due to other causes, such as stroke, Guillain-Barre syndrome, multiple sclerosis, encephalitis, facial nerve tumors, skin tumors, parotid tumors, and facial nerve trauma;.
  • Patients with Hunter's syndrome.
  • Patients with bilateral facial nerve palsy.
  • Patients with hemifacial spasm as the the main clinical symptoms.
  • Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients.
  • Patients with a tendency to bleed easily, who are not suitable for electroacupuncture such as installing a pacemaker, or who cannot cooperate with treatment for other reasons.
  • Participants in other clinical trials within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

MeSH Terms

Conditions

Bell PalsyFacial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Sun, Ph.D

    The Third Clinical College of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Sun, Ph.D

CONTACT

13429610268sunjing0268@163.com

Fei Fang

CONTACT

15068772029fangfei0226@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director of the teaching department

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 27, 2024

Study Start

November 15, 2024

Primary Completion

August 15, 2025

Study Completion

September 15, 2025

Last Updated

November 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)