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NCT06393231 | Recruiting | Peripheral Facial Paralysis

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

Nanjing First Hospital, Nanjing Medical University

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.

Condition or disease

Peripheral Facial Paralysis

Intervention/treatment

acupuncture

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 120 participants
Masking : Double
Primary Purpose : Treatment
Official Title : Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial
Actual Study Start Date : May 2, 2024
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2026
Arm Intervention/treatment

Experimental: observation group

Sunnybrook score ≥83 points

Other: acupuncture

Active Comparator: control group

Sunnybrook score ≥95 points

Other: acupuncture
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis

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

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Locations

Recruiting

China, Jiangsu

Nanjing First Hospital

Nanjing, Jiangsu, China,