Peripheral Facial ParalysisNCT06393231
Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis
A study testing acupuncture in people with Peripheral Facial Paralysis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Facial Paralysis
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-75 years.
- Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
- All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
- Those who voluntarily sign the Research Informed Consent Form
Who cannot join
- Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
- Pregnant or nursing patients.
- Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
- Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu
Bingguo Xu, Director, 13813846072, xubg2008@qq.com
About this study
Official title: Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial
Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.
Read the detailed description
This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.
- Conditions
- Peripheral Facial Paralysis
- Being tested
- acupuncture
- Keywords
- peripheral facial paralysis, acupuncture, sequelae
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called infrared irradiation therapy, moxibustion
Acupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time
| Study group | Role | What they receive |
|---|---|---|
| observation group | Experimental | Sunnybrook score ≥83 points Receives: Other: acupuncture |
| control group | Active comparator | Sunnybrook score ≥95 points Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunnybrook(SB) score
This scoring was used to detect the severity of peripheral facial paralysis(PFP).Which include three parts: resting symmetry, symmetry of voluntary movement, and synkinesis. In the resting symmetry scoring of the facial nerve, "normal" in each area refers to being "symmetrical/equivalent" compared to the healthy side. The total score for facial nerve function assessment is calculated as voluntary movement score minus resting symmetry score minus synkinesis score, with a maximum score of 100.The sunnybrook scores were used to define five categories of PFP severity:Normal person(90~100 points);mild PFP levels(76~89 points);moderate PFP levels(61~75 points);moderate to severe PFP levels(31~60points);and presence of severe PFP(0~30 points)。
Measured: Change from Baseline scores of SB score at at 6-months after onset.
Secondary outcomes (6)
Sunnybrook(SB) score
This scoring was used to detect the severity of peripheral facial paralysis(PFP).Which include three parts: resting symmetry, symmetry of voluntary movement, and synkinesis. In the resting symmetry scoring of the facial nerve, "normal" in each area refers to being "symmetrical/equivalent" compared to the healthy side. The total score for facial nerve function assessment is calculated as voluntary movement score minus resting symmetry score minus synkinesis score, with a maximum score of 100.The sunnybrook scores were used to define five categories of PFP severity:Normal person(90~100 points);mild PFP levels(76~89 points);moderate PFP levels(61~75 points);moderate to severe PFP levels(31~60points);and presence of severe PFP(0~30 points)。
Measured: Change from Baseline scores of SB score at at 3、12months after onset.
Electroneuronography (ENoG)
The goal of the Electroneurography (ENoG) testing is to measure the amount of neural degradation that has occurred distal to the site of facial nerve injury by measuring the muscle response to an electrical stimulus. The testing of ENoG involves recording the compound muscle action potential (CAMP) of the mimetic muscles, including Orbicularis oculi, Frontalis muscle, Orbicularis oris and Zygomaticus muscle. ENoG is performed first on the healthy side of the face and then on the affected side. Nerve damage or nerve fiber degeneration leads to a decrease or loss of the CAMP. The amplitude of the CAMP on the affected side is compared to the CAMP of the healthy side and expressed as percent (amplitude of the paralyzed side divided by the amplitude of the normal side). A side difference of 30% or bigger is considered pathologic.
Measured: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6、12months after onset.
Blink Reflex
The blink reflex test is to measures the facial nerve since the blink reflex delivers information on facial nerve function with normal trigeminal function. Blink reflex testing involves electrical stimulation of the supraorbital nerve on the affected side combined with a 2-channel simultaneous surface electromyogram recording from both orbicularis oculi muscles. The exit of the supraorbital nerve in the supraorbital foramen is palpated on the rim of the orbit. Stimulation with 10-20 mA and 0.2 ms duration is used to produce a constant reflex. In blink reflex testing, two responses, R1 and R2, are analyzed. R1 is the fast ipsilateral response of the orbicularis oculi muscle with a latency of about 10-12 ms. The second bilateral response R2 has a latency of about 30-41 ms. The R2 latency differences between both sides higher than 5-8 ms is considered pathologic.
Measured: Change from Baseline number of pathological Blink Reflex at 6、12months after onset.
Facial disability index (FDI)
The facial disability index (FDI) included the FDI Physical Function Subscale (FDIP) and the FDI Social/Well-being Subscale (FDIS), with a total of 10 questions in each section.The disease severity decreases as the scores rise
Measured: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Self-Rating Anxiety Scale(SAS)
The full name of the scale called Zung Self-Rating Anxiety Scale.The SAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The SAS standard scores were used to define four categories of anxiety severity: within normal ranger no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme anxiety (70-100points).
Measured: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Self-Rating Depression Scale(SDS)
The full name of the scale called Zung Self-Rating Depression Scale.The SDS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Ten questions involve the assessment of increasing depression levels, and ten questions involve decreasing depression levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The SAS standard scores were used to define four categories of depression severity: within normal ranger no significant psychopathology (25-49points);presence of mild to moderate depression levels (53-62points); severe depression levels (63-72points); and presence of extreme depression (73-100points).
Measured: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start2 May 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Facial ParalysisStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingguo Xu, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393231
- Sponsor's protocol ID
- KY20240123-04-KS-01
- Status last verified
- May 2024
- First submitted
- 28 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06393231
- Acronym / sponsor ID
- KY20240123-04-KS-01
- Conditions
- Peripheral Facial Paralysis
- Keywords
- peripheral facial paralysis, acupuncture, sequelae
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 May 2024 (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.
Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.
Detailed description
This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | Experimental | Other: acupunctureSunnybrook score ≥83 points |
| control group | Active comparator | Other: acupunctureSunnybrook score ≥95 points |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients aged 18-75 years.
- Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
- All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
- Those who voluntarily sign the Research Informed Consent Form
Key exclusion criteria (4 listed)
- Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
- Pregnant or nursing patients.
- Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
- Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation
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 |
|---|---|---|
| acupunctureAlso: infrared irradiation therapy, moxibustionAcupuncture is applied to ST8, GB14, BL12, SJ23, ST2, SI18, ST4, ST7, RN24, Ex-HN16, SJ17 and LI4 on the affected side and needles are retained for half an hour.Add infrared irradiation therapy in the same time | Other | control group, observation group |
Primary outcome
Sunnybrook(SB) score
Time frame: Change from Baseline scores of SB score at at 6-months after onset.
This scoring was used to detect the severity of peripheral facial paralysis(PFP).Which include three parts: resting symmetry, symmetry of voluntary movement, and synkinesis. In the resting symmetry scoring of the facial nerve, "normal" in each area refers to being "symmetrical/equivalent" compared to the healthy side. The total score for facial nerve function assessment is calculated as voluntary movement score minus resting symmetry score minus synkinesis score, with a maximum score of 100.The sunnybrook scores were used to define five categories of PFP severity:Normal person(90~100 points);mild PFP levels(76~89 points);moderate PFP levels(61~75 points);moderate to severe PFP levels(31~60points);and presence of severe PFP(0~30 points)。
6 secondary outcomes
Sunnybrook(SB) score
Time frame: Change from Baseline scores of SB score at at 3、12months after onset.
Electroneuronography (ENoG)
Time frame: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6、12months after onset.
Blink Reflex
Time frame: Change from Baseline number of pathological Blink Reflex at 6、12months after onset.
Facial disability index (FDI)
Time frame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Self-Rating Anxiety Scale(SAS)
Time frame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Self-Rating Depression Scale(SDS)
Time frame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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. This study is not recruiting at the moment.
Bingguo Xu study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Peripheral Facial Paralysis, run by Nanjing First Hospital, Nanjing Medical University 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 May 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingguo Xu (13813846072, xubg2008@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunnybrook(SB) score (time frame: Change from Baseline scores of SB score at at 6-months after onset.). 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 16 May 2024.