Clinical trial NCT06393231: Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis
Official title: Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Facial Paralysis
Keywords: peripheral facial paralysis
acupuncture
sequelae
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18-75 years.
2. Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
3. 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.
4. Those who voluntarily sign the Research Informed Consent Form

Exclusion Criteria:

1. Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
2. Pregnant or nursing patients.
3. Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
4. Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation

Primary outcomes:
measure: Sunnybrook(SB) score
timeFrame: Change from Baseline scores of SB score at at 6-months after onset.
Secondary outcomes:
measure: Sunnybrook(SB) score
timeFrame: Change from Baseline scores of SB score at at 3、12months after onset.
measure: Electroneuronography (ENoG)
timeFrame: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6、12months after onset.
measure: Blink Reflex
timeFrame: Change from Baseline number of pathological Blink Reflex at 6、12months after onset.
measure: Facial disability index (FDI)
timeFrame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
measure: Self-Rating Anxiety Scale(SAS)
timeFrame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
measure: Self-Rating Depression Scale(SDS)
timeFrame: Change from Baseline scores of FDI score at at 3、6、12months after onset.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Bingguo Xu
role: STUDY_DIRECTOR
References: