Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China
Prednisone Acetate and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, Comparative Effectiveness Research in China
1 other identifier
interventional
1,800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 20, 2014
August 1, 2014
4.3 years
August 30, 2010
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Neurology examination
10days, 1 month, 2 months, 3months, 4months, 6months
registration of ipsilateral pain
10days, 1 month, 2 months, 3months, 4months, 6months
Study Arms (6)
Prednisolone
EXPERIMENTALPrednisolone as 5 mg tablets will be given within 72 h after onset of Bell's palsy as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.
Acute stage acupuncture
EXPERIMENTALAccept acupuncture therapy within 10days after onset of Bell's palsy, do not accept prednisolone therapy. 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 within 72 h after onset of Bell's palsy. Yifeng (TE17), Hegu (LI4) are punctured 0.5-1.0 cun, the others are punctured 0.1-0.3 cun. and the needles were retained for 30 minutes, once a day, five times a week, for a total period of four weeks.
Prednisolone + acute stage acupuncture
EXPERIMENTALAccept prednisolone and acupuncture therapy within 10days after onset of Bwll's palsy. Prednisolone used as same as the Arm of Prednisolone. The acupuncture points used as same as the Arm of Acute stage acupuncture.
Resting stage acupuncture
EXPERIMENTALAccepted acupuncture therapy after 10 days of the onset of Bell's palsy. 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. 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 7 d after enrolment. 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.
Prednisolone + resting stage acupuncture
EXPERIMENTALAccept prednisolone and acupuncture therapy more than 10days after onset of Bwll's palsy. Prednisolone used as same as the Arm of Prednisolone. The acupuncture points used as same as the Arm of Resting stage acupuncture.
Other treatment
OTHERDo not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously.
Interventions
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.
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.
common medicine or other physical treatment which are different from those 5 Arms Previously.
Eligibility Criteria
You may qualify if:
- involvement of unilateralfacial nerve paralysis only
- aged between 18 and 75 years old
- period of onset of facial paralysis within 72h
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (1)
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.
PMID: 21693007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gang Zhao, MD
the Department of Neurology , Xijing Hospital
- STUDY CHAIR
Feng Xia, MD
the Department of Neurology , Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 14, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2014
Study Completion
April 1, 2015
Last Updated
August 20, 2014
Record last verified: 2014-08