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

Primary Purpose

Bell's Palsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisolone
acupuncture
other treatment
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell's Palsy focused on measuring Bell's palsy, Prednisolone, acupuncture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Department of Neurology , Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Prednisolone

Acute stage acupuncture

Prednisolone + acute stage acupuncture

Resting stage acupuncture

Prednisolone + resting stage acupuncture

Other treatment

Arm Description

Prednisolone 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.

Accept 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.

Accept 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.

Accepted 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.

Accept 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.

Do not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 30, 2010
Last Updated
August 18, 2014
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01201642
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell's Palsy
Keywords
Bell's palsy, Prednisolone, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
Prednisolone 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.
Arm Title
Acute stage acupuncture
Arm Type
Experimental
Arm Description
Accept 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.
Arm Title
Prednisolone + acute stage acupuncture
Arm Type
Experimental
Arm Description
Accept 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.
Arm Title
Resting stage acupuncture
Arm Type
Experimental
Arm Description
Accepted 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.
Arm Title
Prednisolone + resting stage acupuncture
Arm Type
Experimental
Arm Description
Accept 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.
Arm Title
Other treatment
Arm Type
Other
Arm Description
Do not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
other treatment
Intervention Description
common medicine or other physical treatment which are different from those 5 Arms Previously.
Primary Outcome Measure Information:
Title
Assessment of Facial function
Description
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.
Time Frame
10days, 1 month, 2 months, 3months, 4months, 6months
Secondary Outcome Measure Information:
Title
Neurology examination
Description
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.
Time Frame
10days, 1 month, 2 months, 3months, 4months, 6months
Title
registration of ipsilateral pain
Description
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.
Time Frame
10days, 1 month, 2 months, 3months, 4months, 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Zhao, MD
Phone
02984775361
Email
zhaogang@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Organizational Affiliation
the Department of Neurology , Xijing Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Feng Xia, MD
Organizational Affiliation
the Department of Neurology , Xijing Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
the Department of Neurology , Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Phone
02984775361
Email
zhaogang@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Feng Xia, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21693007
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.
Results Reference
derived

Learn more about this trial

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

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