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
Recruitment status was Recruiting
Sponsor:
Xijing Hospital
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01201642
First received: August 30, 2010
Last updated: June 13, 2011
Last verified: March 2010
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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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
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
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 May 23, 2013