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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bell Palsy
• Intervention / Treatment: Device: Active Intradermal Acupuncture; Other: Guided self-rehabilitation management program; Other: Health Education; Device: Sham Intradermal Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 552
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yang Jiang, master; Phone Number: 17768069362; Email: 17768069362@163.com
• Study Contact Backup: Name: Dan Zhang, bachelor; Phone Number: 18662237567; Email: 18662237567@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215600
      • Recruiting
      • Zhangjiagang First People's Hospital
      • Contact: Dan Zhang, bachelor; Phone Number: 18662237567; Email: 18662237567@163.com
      • Contact: Yang Jiang, Master; Phone Number: +8617768069362; Email: 17768069362@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Active intradermal acupuncture" plus "Guided self-rehabilitation management program"; Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught and corrected self-rehabilitation techniques by Physical Medicine and Rehabilitation(PMR) therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.	Device: Active Intradermal Acupuncture; 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.; Other: Guided self-rehabilitation management program; 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.
Experimental: "Active intradermal acupuncture" plus "Health education"; Active IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Active IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.	Device: Active Intradermal Acupuncture; 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.; Other: Health Education; 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
Experimental: "Sham intradermal acupuncture" plus "Guided self-rehabilitation management program"; Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught and corrected self-rehabilitation techniques by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and practice at-home therapy and diarize accomplished exercises.	Other: Guided self-rehabilitation management program; 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.; Device: Sham Intradermal Acupuncture; 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.
Sham Comparator: "Sham intradermal acupuncture" plus "Health education"; Sham IA will be retained in the acupoints for 72h before being removed, then rested for one day.Participants receive Sham IA until full recovery or completion of follow up (a duration of 24 weeks). Participants will be taught health education content about the disease by PMR therapists at regular outpatient clinic visit (twice weekly for the first 12 weeks, then weekly until full recovery or follow-up completed) and have no homework and keep no daily logs.	Other: Health Education; 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; Device: Sham Intradermal Acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with complete recovery of facial function at the 24-week.	The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants with complete recovery of facial function.	The complete recovery of facial function was defined as Sunnybrook Facial Grading System score of 100 points.	Week4, Week8, Week12, Week16, Week20
The time to complete recovery of facial function.	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.	Within 24 weeks
The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.	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.	Week4, Week8, Week12, Week16, Week20, Week24
The changes in Sunnybrook Facial Grading System score from baseline.	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).	Week4, Week8, Week12, Week16, Week20, Week24
The changes in Surface Electromyography from baseline.	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.	Week4, Week12, Week24
The changes in Facial Disability Index physical function subscale from baseline.	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).	Week4, Week12, Week24
The changes in Social Appearance Anxiety Scale from baseline.	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.	Week4, Week12, Week24
The changes in Facial Disability Index social/wellbeing function subscale from baseline	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).	Week4, Week12, Week24
The changes in Facial Clinimetric Evaluation Scale from baseline.	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)	Week4, Week12, Week24
The changes in visual analogue scale from baseline.	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.	Week4, Week8
The proportion of participants with synkinesis.		Week 24
The proportion of participants with facial spasm or contracture		Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of intradermal acupuncture expectation	A brief 4-item Acupuncture Expectancy Scale score ranged from 4 to 20, with higher scores indicating greater expectancy.	Baseline
Evaluation of guided self-rehabilitation management program expectation	Participants will be asked to answer the following question: "Do you think GRMP is helpful for Bell's palsy?"	Baseline
Evaluation of intradermal acupuncture compliance	Compliance Rate=(actual treatment times/total treatment times) *100%.	The 10th day after the onset of palsy until complete recovery or week 24
Evaluation of guided self-rehabilitation management program compliance	Compliance Rate=(actual session times/total session times) *100%. For GRMP homework, we measure and quantify participants' adherence by the daily diary.	The 10th day after the onset of palsy until complete recovery or week 24
Blinding assessment of intradermal acupuncture	Participants will be asked the following question: do you think you have received active intradermal acupuncture in the past weeks?	Week 24
Blinding assessment of guided self-rehabilitation management program	Participants will be asked the following question: do you think you have received guided self-rehabilitation management program in the past weeks?	Week 24
Adverse events assessment	Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.	The 10th day after the onset of palsy to week 24

Collaborators and Investigators

• Sponsor: Zhangjiagang First People's Hospital
• Investigators: Principal Investigator: yang Jiang, master, Zhangjiagang First People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 27, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Bell Palsy; Self-rehabilitation; Intradermal acupuncture
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cranial Nerve Diseases; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis
• Other Study ID Numbers: ZJGYYLL202407030; LSD2022020 (Other Grant/Funding Number: Jiangsu Provincial Health Commission); ZJGQNKJ202231 (Other Grant/Funding Number: Zhangjiagang City Health Commission)

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