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

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.

Study Overview

• Status: Unknown
• Conditions: Bell's Palsy
• Intervention / Treatment: Drug: Prednisolone; Device: acupuncture; Other: other treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gang Zhao, MD; Phone Number: 02984775361; Email: zhaogang@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • The Department of Neurology , Xijing Hospital
      • Contact: Gang Zhao, MD; Phone Number: 02984775361; Email: zhaogang@fmmu.edu.cn
      • Principal Investigator: Feng Xia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prednisolone; 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.	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.
Experimental: Acute stage acupuncture; 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.	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.
Experimental: Prednisolone + acute stage acupuncture; 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.	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.
Experimental: Resting 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.	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.
Experimental: Prednisolone + resting stage acupuncture; 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.	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; Do not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously.	Other: other treatment; common medicine or other physical treatment which are different from those 5 Arms Previously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Feng Xia, MD, The Department of Neurology , Xijing Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: acupuncture; Prednisolone; Bell's palsy
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Neuritis; Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: XijingNeuro-2010