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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Xijing Hospital

Current Primary Outcome: Assessment of Facial function [ Time Frame: 10days, 1 month, 2 months, 3months, 4months, 6months ]

Original Primary Outcome: Assessment of Facial function [ Time Frame: 7 days,17days,1 month, 2 months, 3 months,6months ]

Current Secondary Outcome:

• Neurology examination [ Time Frame: 10days, 1 month, 2 months, 3months, 4months, 6months ]
  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.
• registration of ipsilateral pain [ Time Frame: 10days, 1 month, 2 months, 3months, 4months, 6months ]
  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.

Original Secondary Outcome:

• Neurology examination [ Time Frame: 7days,17days, 1 month, 2 months ]
• registration of ipsilateral pain [ Time Frame: 7days,17days, 1 month, 2 months ]
  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.

Information By: Xijing Hospital

Dates:
Date Received: August 30, 2010
Date Started: September 2010
Date Completion: April 2015
Last Updated: August 18, 2014
Last Verified: August 2014