EA Treatment With Different Waveform for Subacute BP:Study Protocol for a Randomized Controlled Trial

May 30, 2026 updated by: Jing Sun, The Third Affiliated hospital of Zhejiang Chinese Medical University

Treatment of Electroacupuncture With Different Waveform for Subacute Peripheral Facial Paralysis:Study Protocol for a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This parallel-group, multicenter randomized clinical trial (RCT) will be conducted at the outpatient clinic of three hospitals in China.A total of seventy-five eligible patients will be randomly divided into low frequency continuous wave(n=25) ,discontinuous wave(n=25) and dilatational wave (n=25) groups.All groups will receive traditional acupuncture treatment at selected acupoints (BL2,GB1,GB14,ST2,SI18,ST4,ST6,ST7,SJ17,EX-HN16,EX-HN5,LI4),additionally,receive different waveform of electroacupuncture treatment for 20 minutes three times per week for four weeks.Facial Nerve Grading System 2.0 (FNGS 2.0) will be used to assess the curative effect at baseline and at 4 weeks after treatment, as the primary outcome.Sunnybrook facialgrad-ingsystem(SFGS) and Facial Disability Index (FDI)Scale will be measured and analyzed at baseline and at 4 weeks after treatment, as secondary outcomes.In addition,amplitude ratio of the affected/healthy side will be another secondary outcome tested by ENoG at bsaeline.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310053
        • The Third Affiliated hospital of Zhejiang Chinese Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients meet the clinical classification criteria for BP, diagnosed by specialist.
  2. 1-3 weeks from onset.
  3. Male or female patients aged 18-65 years.
  4. FNGS2.0≥4
  5. Clearly aware, able to complete normal communication, signed informed consent.

Exclusion Criteria:

  1. 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;.
  2. Patients with Hunter's syndrome.
  3. Patients with bilateral facial nerve palsy.
  4. Patients with hemifacial spasm as the the main clinical symptoms.
  5. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients.
  6. 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.
  7. Participants in other clinical trials within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low-frequency continuous wave group
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
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.
Experimental: discontinuous wave group
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
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.
Experimental: dilatational wave group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0)
Time Frame: Baseline,4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline score of the Sunnybrook grading(SFGS) scale
Time Frame: Baseline,4 weeks
The Sunnybrook grading scale includes 3 subscales, which are the resting symmetry subscale, the symmetry of voluntary movement subscale, and the synkinesis subscale. In the resting symmetry subscale, the minimal score is 0, which indicates normal resting symmetry, and the maximal score is 20, which indicates the most severe resting asymmetry. In the symmetry of voluntary movement subscale, the minimal score is 20, which indicates gross asymmetry of voluntary movement, and the maximal score is 100, which indicates normal symmetry of voluntary movement. And in the synkinesis subscale, the minimal score is 0, which indicates no involuntary muscle contraction associated with each expression, and the maximal score is 15, which indicates the most severe involuntary muscle contraction associated with each expression. The composite score equals to the symmetry of voluntary movement score minus the resting symmetry score and the synkinesis score.
Baseline,4 weeks
Change from Baseline score of the Facial Disability Index(FDI)
Time Frame: Baseline,4 weeks
The FDI is a brief, self-report questionnaire of physical disability and psychosocial factors related to facial neuromuscular function. It was intended to assess disability and the outcome of intervention in terms of meaningful change in the patient's physical disability and psychosocial status.
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.
Time Frame: Baseline
Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Collaborators

Zhejiang University
The First Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Jing Sun, Ph.D, The Third Clinical College of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

August 24, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZY-ZJ-KY-23071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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