Bell PalsyNCT06778473
Intradermal Acupuncture and Self-rehabilitation Program in Patients With Severe Bell's Palsy
A study testing Active Intradermal Acupuncture, Guided self-rehabilitation management program and Health Education in people with Bell Palsy, run by Zhangjiagang First People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Active Intradermal Acupuncture, Guided self-rehabilitation management program and Health Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Yang Jiang, Master, +8617768069362, 17768069362@163.com
Dan Zhang, bachelor, 18662237567, 18662237567@163.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Bell Palsy
- Being tested
- Active Intradermal Acupuncture, Sham Intradermal Acupuncture, Guided self-rehabilitation management program, Health Education
- Keywords
- Bell Palsy, Intradermal acupuncture, Self-rehabilitation
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intradermal AcupunctureDevice
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 AcupunctureDevice
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 programOther
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 EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| "Active intradermal acupuncture" plus "Guided self-rehabilitation management program" | Experimental | 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. Receives: Device: Active Intradermal Acupuncture; Other: Guided self-rehabilitation management program |
| "Active intradermal acupuncture" plus "Health education" | Experimental | 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. Receives: Device: Active Intradermal Acupuncture; Other: Health Education |
| "Sham intradermal acupuncture" plus "Guided self-rehabilitation management program" | Experimental | 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. Receives: Device: Sham Intradermal Acupuncture; Other: Guided self-rehabilitation management program |
| "Sham intradermal acupuncture" plus "Health education" | Sham comparator | 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. Receives: Device: Sham Intradermal Acupuncture; Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Week4, Week8
The proportion of participants with synkinesis.
Measured: Week 24
The proportion of participants with facial spasm or contracture
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start24 Mar 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two by two factorial design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangjiagang First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jiang, Zhangjiagang First People's Hospital
- Investigators
- yang Jiang, master, Principal investigator, Zhangjiagang First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778473
- Sponsor's protocol ID
- ZJGYYLL202407030
- Other IDs
- LSD2022020, ZJGQNKJ202231
- Status last verified
- Apr 2025
- First submitted
- 12 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06778473
- Acronym / sponsor ID
- ZJGYYLL202407030
- Conditions
- Bell Palsy
- Keywords
- Bell Palsy, Intradermal acupuncture, Self-rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Zhangjiagang First People's HospitalUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Two by two factorial design
| Arm | Type | Receives |
|---|---|---|
| "Active intradermal acupuncture" plus "Guided self-rehabilitation management program" | Experimental | Device: Active Intradermal Acupuncture, Other: Guided self-rehabilitation management programActive 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. |
| "Active intradermal acupuncture" plus "Health education" | Experimental | Device: Active Intradermal Acupuncture, Other: Health EducationActive 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. |
| "Sham intradermal acupuncture" plus "Guided self-rehabilitation management program" | Experimental | Device: Sham Intradermal Acupuncture, Other: Guided self-rehabilitation management programSham 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. |
| "Sham intradermal acupuncture" plus "Health education" | Sham comparator | Device: Sham Intradermal Acupuncture, Other: Health EducationSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Intradermal AcupunctureDepending 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. | Device | "Active intradermal acupuncture" plus "Guided self-rehabilitation management program", "Active intradermal acupuncture" plus "Health education" |
| Sham Intradermal AcupunctureSham 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. | Device | "Sham intradermal acupuncture" plus "Guided self-rehabilitation management program", "Sham intradermal acupuncture" plus "Health education" |
| Guided self-rehabilitation management programSelf-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. | Other | "Active intradermal acupuncture" plus "Guided self-rehabilitation management program", "Sham intradermal acupuncture" plus "Guided self-rehabilitation management program" |
| Health EducationHealth 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 | Other | "Active intradermal acupuncture" plus "Health education", "Sham intradermal acupuncture" plus "Health education" |
Primary outcome
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.
12 secondary outcomes
The proportion of participants with complete recovery of facial function.
Time frame: Week4, Week8, Week12, Week16, Week20
The time to complete recovery of facial function.
Time frame: Within 24 weeks
The proportion of participants to reach a House-brackmann facial nerve grading system grade of I.
Time frame: Week4, Week8, Week12, Week16, Week20, Week24
The changes in Sunnybrook Facial Grading System score from baseline.
Time frame: Week4, Week8, Week12, Week16, Week20, Week24
The changes in Surface Electromyography from baseline.
Time frame: Week4, Week12, Week24
The changes in Facial Disability Index physical function subscale from baseline.
Time frame: Week4, Week12, Week24
The changes in Social Appearance Anxiety Scale from baseline.
Time frame: Week4, Week12, Week24
The changes in Facial Disability Index social/wellbeing function subscale from baseline
Time frame: Week4, Week12, Week24
The changes in Facial Clinimetric Evaluation Scale from baseline.
Time frame: Week4, Week12, Week24
The changes in visual analogue scale from baseline.
Time frame: Week4, Week8
The proportion of participants with synkinesis.
Time frame: Week 24
The proportion of participants with facial spasm or contracture
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yang Jiang, master principal investigator
Zhangjiagang First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intradermal Acupuncture, Guided self-rehabilitation management program and Health Education in people with Bell Palsy, run by Zhangjiagang First People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yang Jiang, master (17768069362, 17768069362@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with complete recovery of facial function at the 24-week. (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.