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

NCT06393231 | Recruiting

• 1 other identifier: KY20240123-04-KS-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Facial Paralysis

Keywords

peripheral facial paralysis; acupuncture; sequelae

Outcome Measures

Primary Outcomes (1)

• 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）。

  Change from Baseline scores of SB score at at 6-months after onset.

Secondary Outcomes (6)

• Sunnybrook(SB) score

  Change from Baseline scores of SB score at at 3、12months after onset.

• Electroneuronography (ENoG)

  Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6、12months after onset.

• Blink Reflex

  Change from Baseline number of pathological Blink Reflex at 6、12months after onset.

• Facial disability index (FDI)

  Change from Baseline scores of FDI score at at 3、6、12months after onset.

• Self-Rating Anxiety Scale(SAS)

  Change from Baseline scores of FDI score at at 3、6、12months after onset.

Study Arms (2)

observation group

EXPERIMENTAL

Sunnybrook score ≥83 points

Other: acupuncture

control group

ACTIVE COMPARATOR

Sunnybrook score ≥95 points

Other: acupuncture

Interventions

acupuncture OTHER

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

Also known as: infrared irradiation therapy, moxibustion

control group; observation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Interventions

Acupuncture Therapy; Moxibustion

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Bingguo Xu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Bingguo Xu

CONTACT

13813846072; xubg2008@qq.com

xiaohan zhang

CONTACT

15955165670; zhangxiaohan3000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 2, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)