Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis

Nanjing Medical University

Status: Enrolling

Conditions: Peripheral Facial Paralysis

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06393231

KY20240123-04-KS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

observation group

Experimental group

Description:

Sunnybrook score ≥83 points

Treatment:

Other: acupuncture

control group

Active Comparator group

Description:

Sunnybrook score ≥95 points

Treatment:

Other: acupuncture