Bell's PalsyNCT01201642
Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China
A study testing Prednisolone, acupuncture and other treatment in people with Bell's Palsy, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Prednisolone, acupuncture and other treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- involvement of unilateralfacial nerve paralysis only
- aged between 18 and 75 years old
- period of onset of facial paralysis within 72h
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Zhao, MD, 02984775361, zhaogang@fmmu.edu.cn
Feng Xia, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Bell's Palsy
- Being tested
- Prednisolone, acupuncture, other treatment
- Keywords
- Bell's palsy, Prednisolone, acupuncture
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
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.
acupunctureDevice
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 treatmentOther
common medicine or other physical treatment which are different from those 5 Arms Previously.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | 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. Receives: Drug: Prednisolone |
| Acute stage acupuncture | Experimental | 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. Receives: Device: acupuncture |
| Prednisolone + acute stage acupuncture | Experimental | 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. Receives: Drug: Prednisolone; Device: acupuncture |
| Resting stage acupuncture | Experimental | 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. Receives: Device: acupuncture |
| Prednisolone + resting stage acupuncture | Experimental | 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. Receives: Drug: Prednisolone; Device: acupuncture |
| Other treatment | Other | Do not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously. Receives: Other: other treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10days, 1 month, 2 months, 3months, 4months, 6months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 10days, 1 month, 2 months, 3months, 4months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, MD, Study director, the Department of Neurology , Xijing HospitalFeng Xia, MD, Study chair, the Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201642
- Sponsor's protocol ID
- XijingNeuro-2010
- Status last verified
- Aug 2014
- First submitted
- 30 Aug 2010
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21693007
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Acetate and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, Comparative Effectiveness Research in China
- ClinicalTrials.gov ID
- NCT01201642
- Acronym / sponsor ID
- XijingNeuro-2010
- Conditions
- Bell's Palsy
- Keywords
- Bell's palsy, Prednisolone, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: PrednisolonePrednisolone 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 | Experimental | Device: acupunctureAccept 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 | Experimental | Drug: Prednisolone, Device: acupunctureAccept 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 | Experimental | Device: acupunctureAccepted 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 | Experimental | Drug: Prednisolone, Device: acupunctureAccept 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 | Other | Other: other treatmentDo not accept neither prednisolone nor acupuncture therapy. The therapy accepted is different from the five Arms Previously. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- involvement of unilateralfacial nerve paralysis only
- aged between 18 and 75 years old
- period of onset of facial paralysis within 72h
Key exclusion criteria (13 listed)
- pregnancy
- breastfeeding
- being a woman of child bearing age who is unwilling to use contraceptives during the medication period
- other neurological diseases
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisolonePrednisolone 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 + acute stage acupuncture, Prednisolone + resting stage acupuncture |
| acupunctureThe 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. | Device | Acute stage acupuncture, Prednisolone + acute stage acupuncture, Prednisolone + resting stage acupuncture, Resting stage acupuncture |
| other treatmentcommon medicine or other physical treatment which are different from those 5 Arms Previously. | Other | Other treatment |
Primary outcome
Assessment of Facial function
Time frame: 10days, 1 month, 2 months, 3months, 4months, 6months
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.
2 secondary outcomes
Neurology examination
Time frame: 10days, 1 month, 2 months, 3months, 4months, 6months
registration of ipsilateral pain
Time frame: 10days, 1 month, 2 months, 3months, 4months, 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 21693007Xia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zhao, MD study director
the Department of Neurology , Xijing Hospital
Feng Xia, MD study chair
the Department of Neurology , Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisolone, acupuncture and other treatment in people with Bell's Palsy, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Zhao, MD (02984775361, zhaogang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Facial function (time frame: 10days, 1 month, 2 months, 3months, 4months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.