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| ID | Type | Description | Link |
|---|---|---|---|
| LSD2022020 | Other Grant/Funding Number | Jiangsu Provincial Health Commission | |
| ZJGQNKJ202231 | Other Grant/Funding Number | Zhangjiagang City Health Commission |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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. |
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| "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. |
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| "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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yang Jiang, master | Contact | 17768069362 | 17768069362@163.com | |
| Dan Zhang, bachelor | Contact | 18662237567 | 18662237567@163.com |
| Name | Affiliation | Role |
|---|---|---|
| yang Jiang, master | Zhangjiagang First People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhangjiagang First People's Hospital | Recruiting | Suzhou | Jiangsu | 215600 | China |
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Two by two factorial design
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| "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. |
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| 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. |
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| 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. |
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| 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 |
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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 |
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 |
| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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