Prednisolone and Acupuncture in Bell's Palsy: a Randomised, Placebo-controlled, Multicentre Trial in China

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01201642
First received: August 30, 2010
Last updated: June 13, 2011
Last verified: March 2010
  Purpose

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.


Condition Intervention
Bell's Palsy
Drug: Prednisolone
Device: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prednisolone and Acupuncture in Bell's Palsy: a Randomised, Placebo-controlled, Multicentre Trial in China

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Assessment of Facial function [ Time Frame: 7 days,17days,1 month, 2 months, 3 months,6months ] [ Designated as safety issue: Yes ]
    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) at 2 or 3 months, the next follow-up will be at 6 months.


Secondary Outcome Measures:
  • Neurology examination [ Time Frame: 7days,17days, 1 month, 2 months ] [ Designated as safety issue: Yes ]
  • registration of ipsilateral pain [ Time Frame: 7days,17days, 1 month, 2 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1200
Study Start Date: September 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: placebo + placebo
Experimental: placebo + 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.
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.
Other Name: Prednisolone
Experimental: placebo + acute stage 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 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.
Other Name: acupuncture
Experimental: prednisolone + acute stage acupuncture
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 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.
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.
Other Name: Prednisolone
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 Name: acupuncture
Experimental: placebo + resting stage 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. 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.
Other Name: acupuncture
Experimental: prednisolone + resting stage acupuncture

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. 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.

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.
Other Name: Prednisolone
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 Name: acupuncture

Detailed Description:

Patients will be recruited between Sep, 2010, and Dec, 2011. Baseline assessments before the start of treatment include neurological examination, grading of facial function, measurement of ipsilateral pain, documentation of concurrent medication.

Patients will be randomly assigned to one of six treatment groups by use of a factorial method. A random number table will be applied for randomization, and serially numbered, opaque, sealed envelopes will be used to ensure adequate concealment of patient identity.

These patients are randomly assigned to receive one of the following six treatment groups, i.e. 1) placebo plus placebo group, 2) placebo plus prednisolone group, 3) placebo plus acute stages acupuncture group, 4) prednisolone plus acute stages acupuncture group, 5) placebo plus resting stage acupuncture group, 6) prednisolone plus resting stage acupuncture group. 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201642

Contacts
Contact: Gang Zhao, MD 02984775361 zhaogang@fmmu.edu.cn

Locations
China, Shaanxi
the Department of Neurology , Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Gang Zhao, MD    02984775361    zhaogang@fmmu.edu.cn   
Principal Investigator: Feng Xia, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Study Chair: Feng Xia, MD the Department of Neurology , Xijing Hospital
  More Information

No publications provided by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01201642     History of Changes
Other Study ID Numbers: XijingNeuro-2010
Study First Received: August 30, 2010
Last Updated: June 13, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Bell's palsy
Prednisolone
acupuncture

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Paralysis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics

ClinicalTrials.gov processed this record on August 18, 2014