An interventional study of Active Intradermal Acupuncture and Sham Intradermal Acupuncture in Bell Palsy, sponsored by Zhangjiagang First People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Zhangjiagang First People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's planned enrollment of 552 is above the median of 42 across 70 interventional studies indexed under Bell Palsy.
Browse Bell Palsy studies →Zhangjiagang First People's Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: 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 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 · Other: 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 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.
Device: Sham Intradermal Acupuncture · Other: 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 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: Sham Intradermal Acupuncture · Other: Health Education
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 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.
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 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
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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
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
Evaluation of intradermal acupuncture expectation
A brief 4-item Acupuncture Expectancy Scale score ranged from 4 to 20, with higher scores indicating greater expectancy.
Time frame: 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?"
Time frame: Baseline
Evaluation of intradermal acupuncture compliance
Compliance Rate=(actual treatment times/total treatment times) \*100%.
Time frame: 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.
Time frame: 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?
Time frame: 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?
Time frame: 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.
Time frame: The 10th day after the onset of palsy to week 24
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Sep 2029, 54 months after the start.
Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 54 months is above that.
Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
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Zhangjiagang First People's Hospital