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NCT Number: NCT06573697

EA Treatment With Different Waveform for Subacute BP: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.

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Key information

Conditions

Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Facial Paralysis Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

low-frequency continuous wave EA

Other

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.

discontinuous wave EA

Other

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.

dilatational wave EA

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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