Clinical trial NCT01201642: Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China
Official title: Prednisone Acetate and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, Comparative Effectiveness Research in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bell's Palsy
Keywords: Bell's palsy
Prednisolone
acupuncture
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 inﬂuenced by the study medication or that might have affected completion of the study.

Primary outcomes:
measure: Assessment of Facial function
timeFrame: 10days, 1 month, 2 months, 3months, 4months, 6months
Secondary outcomes:
measure: Neurology examination
timeFrame: 10days, 1 month, 2 months, 3months, 4months, 6months
measure: registration of ipsilateral pain
timeFrame: 10days, 1 month, 2 months, 3months, 4months, 6months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the Department of Neurology , Xijing Hospital
state: Shaanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
affiliation: the Department of Neurology , Xijing Hospital
name: Feng Xia, MD
role: STUDY_CHAIR
References:
citation: Xia F, Han J, Liu X, Wang J, Jiang Z, Wang K, Wu S, Zhao G. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial. Trials. 2011 Jun 21;12:158. doi: 10.1186/1745-6215-12-158.