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NCT Number: NCT06778473

Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy

This study aims to assess the effect of intradermal acupuncture(IA) and guided self-rehabilitation management program(GRMP) (either single or combined) for patients with severe Bell's Palsy.

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Key information

Conditions

Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

After confirming the details of the trial process and signing an informed consent, all participants will be randomly divided into the following four groups: Active IA+GRMP, Active IA+ HE, sham IA+ GRMP, sham IA + HE. They will receive active or sham IA and GRMP or HE until complete recovery or completion of follow up (a duration of 24 weeks).Follow-ups will be done in 4-week, 8-week, 12-week,16-week, 20-week, and 24-week.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with Bell's palsy according to "Clinical Practice Guideline: Bell's Palsy" published by AAO-HNS in 2013;
  • First onset of Bell's palsy with only one side affected;
  • On the 10th day after the onset of palsy, HBGS score ranging from grade IV to VI;
  • According to the latest Chinese Guidelines for Bell's Palsy, within 72 hours of symptom onset for Bell's Palsy, oraling prednisolone 30mg qd for 5 days, followed by tapering to zero in decrements of 5 mg per day;
  • Adults aged 18 years of age or older (no limitation on gender).

Exclusion criteria

  • Facial paralysis caused by acoustic neuroma, otitis media, mastoiditis, mumps, Hunter's syndrome, cranial base meningitis, intracranial metastasis of cancer or multiple sclerosis;
  • Fear of intradermal acupuncture;
  • allergy to adhesive tape;
  • Severe allergic diseases, significant skin lesions, tumors, and severe or unstable internal diseases involving the cardiovascular, respiratory, endocrine, digestive, or hematological system;
  • Cognitive impairment, mental illness, contagious disease, pregnant and lactating;
  • Previously treated withintradermal acupuncture or participating in other clinical trial within 3 months.

Treatment and study plan

Active Intradermal Acupuncture

Device

Depending on acupoints' location, φ0.20*1.5mm or φ0.20*1.2mm AIA will be selected. Insert the Active IA vertically into the acupoint and retain it in the skin.

Active IA will be retained for 72 hours with a day's rest after removal. During the period of needle retention, participants will be required to press the Active IA 4 times a day for approximately 1 minute each time, with as much stimulation as the patient can tolerate, at intervals of approximately 4 hours.

sham intradermal acupuncture

Device

Sham intradermal acupuncture will be attached to the acupoints and retained for 72 hours with a day's rest after removal. During the period of sham needle retention,pressing times and frequencies are identical to those in the active intradermal acupuncture group.

Guided self-rehabilitation management program

Other

Self-rehabilitation techniques are taught in individual sessions of about 40 minutes at each outpatient clinic visit, as detailed below: Analysis of the problem, Education, Massage, Facial muscles exercise,Synkinesis or spasticity management, Homework. Participants are requested to perform daily facial muscle exercises as prescribed by the therapist and keep the written diary on a daily basis. The therapists retrieve and evaluate the diaries at each visit.

Health education

Other

Health education knowledge about the disease such as etiology, pathology,clinical symptoms of Bell's palsy, Bell's palsy diagnosis and role of medical tests;medication education;complications and sequelae,etc

Primary outcomes

  1. The proportion of participants with complete recovery of facial function at the 24-week.

    Time frame: Week 24

    The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.

Secondary outcomes

  1. The proportion of participants with complete recovery of facial function.

    Time frame: Week4, Week8, Week12, Week16, Week20

    The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.

  2. The time to complete recovery of facial function.

    Time frame: Within 24 weeks

    The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.The recovery time is defined as the time from onset of Bell's palsy until complete recovery of facial function.

  3. The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.

    Time frame: Week4, Week8, Week12, Week16, Week20, Week24

    House-Brackmann facial nerve grading system provides a simple comprehensive evaluation of the resting and moving states of facial muscles, involving a six-point scale with I being normal and VI total, flaccid paralysis.

  4. The changes in Sunnybrook Facial Grading System score from baseline.

    Time frame: Week4, Week8, Week12, Week16, Week20, Week24

    SFGS is based on the evaluation of resting symmetry , degree of voluntary excursion of facial muscles, and degree of synkinesis associated with specified voluntary movement. Possible scores range from 0(total paralysis) to 100(normal).

  5. The changes in Surface Electromyography from baseline.

    Time frame: Week4, Week12, Week24

    The main analytical indicator of sEMG used currently in Bell's palsy detection is the root mean square (RMS)value,quantified as the ratio of the infected side to the unaffected side (%).The higher the ratio, the better the facial nerve function recovery.

  6. The changes in Facial Disability Index physical function subscale from baseline.

    Time frame: Week4, Week12, Week24

    Facial Disability Index(FDI) is a disease-specific, self-report instrument designed to evaluate the degree of disability in patients with facial nerve disorders.FDI includes 2 subscales: the FDI- physical function subscale and the FDI-social/ wellbeing function subscale.Possible scores of every subscale range from 0(worst) to 100(best).

  7. The changes in Social Appearance Anxiety Scale from baseline.

    Time frame: Week4, Week12, Week24

    The SAAS is a psychometrically validated measure of social anxiety about one's appearance.Possible scores range from 16 to 80, with higher scores indicating higher degree of social appearance anxiety.

  8. The changes in Facial Disability Index social/wellbeing function subscale from baseline

    Time frame: Week4, Week12, Week24

    Facial Disability Index(FDI) is a disease-specific, self-report instrument designed to evaluate the degree of disability in patients with facial nerve disorders.FDI includes 2 subscales: the FDI- physical function subscale and the FDI-social/ wellbeing function subscale.Possible scores of every subscale range from 0(worst) to 100(best).

  9. The changes in Facial Clinimetric Evaluation Scale from baseline.

    Time frame: Week4, Week12, Week24

    The FACE questionnaire is a validated instrument that is used to assess quality of life related to peripheral facial palsy. Possible scores range from 0(worst) to 100(best)

  10. The changes in visual analogue scale from baseline.

    Time frame: Week4, Week8

    Pain around the ear, in the face, or in the neck is assessed using VAS that ranged from 0 to 10 points, where 0 was no pain and 10 very severe pain.

  11. The proportion of participants with synkinesis.

    Time frame: Week 24

  12. The proportion of participants with facial spasm or contracture

    Time frame: Week 24

Other outcomes

  1. Evaluation of intradermal acupuncture expectation

    Time frame: Baseline

    A brief 4-item Acupuncture Expectancy Scale score ranged from 4 to 20, with higher scores indicating greater expectancy.

  2. Evaluation of guided self-rehabilitation management program expectation

    Time frame: Baseline

    Participants will be asked to answer the following question: "Do you think GRMP is helpful for Bell's palsy?"

  3. Evaluation of intradermal acupuncture compliance

    Time frame: The 10th day after the onset of palsy until complete recovery or week 24

    Compliance Rate=(actual treatment times/total treatment times) *100%.

  4. Evaluation of guided self-rehabilitation management program compliance

    Time frame: The 10th day after the onset of palsy until complete recovery or week 24

    Compliance Rate=(actual session times/total session times) *100%. For GRMP homework, we measure and quantify participants' adherence by the daily diary.

  5. Blinding assessment of intradermal acupuncture

    Time frame: Week 24

    Participants will be asked the following question: do you think you have received active intradermal acupuncture in the past weeks?

  6. Blinding assessment of guided self-rehabilitation management program

    Time frame: Week 24

    Participants will be asked the following question: do you think you have received guided self-rehabilitation management program in the past weeks?

  7. Adverse events assessment

    Time frame: The 10th day after the onset of palsy to week 24

    Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Zhang, bachelor

CONTACT

[email protected]

18662237567

yang Jiang, master

CONTACT

[email protected]

17768069362

Sponsors and collaborators

Lead sponsor

Zhangjiagang First People's Hospital

Other

Registry information

Official study title

Effectiveness of Intradermal Acupuncture and Guided Self-rehabilitation Management Program for Severe Bell's Palsy Patients: a Randomized, Placebo-controlled, 2×2 Factorial Trial

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 16, 2025
Registry last updated
Apr 30, 2025

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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