Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China

Bell's Palsy Clinical Trial

Official title:

Prednisone Acetate and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, Comparative Effectiveness Research in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01201642
• Other study ID #: XijingNeuro-2010
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2010
• Last updated: August 18, 2014
• Start date: September 2010
• Est. completion date: April 2015

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: Gang Zhao, MD
• Phone: 02984775361
• Email: zhaogang[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify that whether in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients.

Description:

Patients will be recruited between Sep, 2010, and Dec, 2014. Baseline assessments before the start of treatment include neurological examination, grading of facial function, measurement of ipsilateral pain, documentation of concurrent medication.

These patients are assigned to receive one of the following treatment groups, i.e. 1)the hormone group: oral hormone drugs, do not accept acupuncture treatment; 2)acupuncture group: using acupuncture therapy, do not accept oral hormone therapy; 3)hormone-acupuncture combined treatment group: receive oral hormone and acupuncture therapy at the same time; 4)other treatment group: other treatment in addition to the above 3 groups of treatment abroad. The secondary factor grouping (subgroup): According to the different time of treatment after the onset of disease, the acupuncture group and the hormone- acupuncture combined treatment group can be divided into Type Ⅰ subgroup (patients receive acupuncture within 10 days of the onset of disease) and Type II subgroups (patients receive acupuncture after 10 days of the onset of disease). The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain), the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• involvement of unilateralfacial nerve paralysis only

• aged between 18 and 75 years old

• period of onset of facial paralysis within 72h

Exclusion Criteria:

• pregnancy

• breastfeeding

• being a woman of child bearing age who is unwilling to use contraceptives during the medication period

• other neurological diseases

• diabetes

• badly controlled hypertension

• current or a history of serious heart disease

• history of renal or hepatic disease

• gastric or duodenal ulcer

• history of glaucoma

• acute otitis or history of ipsilateral chronic otitis

• history of tuberculosis, history of immunodeficiency syndromes

• recent head injury, psychiatric disease, or any other condition that is at risk of being in?uenced by the study medication or that might have affected completion of the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bell Palsy
• Bell's Palsy
• Facial Paralysis

Intervention

Drug:
• Prednisolone
Prednisolone as 5 mg tablets will be given as a single dose of 40 mg daily for 10 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.

Device:
• acupuncture
The acupuncture points used were Dicang (ST4), Jiache (ST6), Yangbai (GB14), Xiaguan (ST7), Taiyang (EX-HN5), Quanliao (SI18) and Yifeng (TE17) on the affected side, and Hegu (LI4) bilaterally. For acute stages acupuncture, shallow puncturing is used at facial acupoints and routine puncturing is used at other acupoints. For resting stage acupuncture, penetrative needling is used from Dicang (ST4) to Jiache (ST6) and from Taiyang (EX-HN5) to Quanliao (SI18) 2-3 cun, and routine puncturing is used at other acupoints. Filiform needles (33 - 49.5 mm, 0.32 mm) will be used with moderate stimulation to get an acupuncture sensation, and the needles were retained for 30 minutes, once a day, five times a week, for a total period of four weeks.

Other:
• other treatment
common medicine or other physical treatment which are different from those 5 Arms Previously.

Locations

Country	Name	City	State
China	the Department of Neurology , Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Facial function	Facial function will be assessed at all visits with two grading systems( The Sunnybrook system and The House-Brackmann scale ).If recovery is complete (Sunnybrook scale score of 100 points), the next follow-up will be at 6 months.	10days, 1 month, 2 months, 3months, 4months, 6months	Yes
Secondary	Neurology examination	Pain around the ear, in the face, or in the neck will be registered on a visual analogue scale that ranges from 0 to 10 points, where 0 is no pain and 10 very severe pain. Occurrence of facial spasm or contracture and synkinesia in the different treatment arms at any time will be observed and recorded.	10days, 1 month, 2 months, 3months, 4months, 6months	Yes
Secondary	registration of ipsilateral pain	Pain around the ear, in the face, or in the neck will be registered on a visual analogue scale that rangs from 0 to 10 points, where 0 is no pain and 10 very severe pain.	10days, 1 month, 2 months, 3months, 4months, 6months	Yes