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

Last updated: May 13, 2024
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cataplexy

Treatment

acupuncture

Clinical Study ID

NCT06393231
KY20240123-04-KS-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged 18-75 years.

  2. Patients diagnosed with peripheral facial paralysis≤7 days before screening and wasthe first time.

  3. All cases have symptoms and signs or have been examined by CT, MRI, etc., excludingperipheral facial paralysis caused by central nervous system diseases, ear diseases,and trauma.

  4. Those who voluntarily sign the Research Informed Consent Form

Exclusion

Exclusion Criteria:

  1. Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (morethan two occurrences).

  2. Pregnant or nursing patients.

  3. Patients with critically ill which is difficult to make a definite evaluation of theefficacy and safety of treatment

  4. Those who accept other treatment methods or cannot adhere to this plan, whichaffects the efficacy observation

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: acupuncture
Phase:
Study Start date:
May 02, 2024
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Nanjing First Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

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