Bell's PalsyNCT00608660
Randomized Controlled Trial of Acupuncture to Treat Bell's Palsy According to Different Stages
A study testing acupuncture, acupuncture and moxibustion and electroacupuncture in people with Bell's Palsy, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- acupuncture, acupuncture and moxibustion and electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- Oct 2006to Sep 2009
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients who meet the diagnosis, stages, location criteria
- the first time to onset the disease
- between 1 and 70 days with the onset time of facial palsy
- on one side of the face paralysis
- between 15 and 70 years old with the onset age of facial palsy
- willing to finish the whole observation period
- with written consent form signed by themselves.
Who cannot join
- facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
- facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
- patient with Hunt's syndrome
- patient with facial spasm
- pregnant women or women in lactation
- patients are participating other clinical research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying of Acupuncture for Bell's Palsy According to Different Stages
The purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy
Read the detailed description
The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy
- Conditions
- Bell's Palsy
- Being tested
- acupuncture, acupuncture and moxibustion, electroacupuncture, acupuncture along yangming tendons
- Keywords
- Peripheral Facial Paralysis, Acupuncture, RCT
- Medical subject headings
- Bell Palsy, Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
staging acupuncture
acupuncture and moxibustionOther
staging acupuncture and moxibustion
electroacupunctureOther
staging electroacupuncture
acupuncture along yangming tendonsOther
staging acupuncture along Yangming musculature
acupunctureOther
non-staging acupuncture
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | staging acupuncture for treating Bell's Palsy Receives: Other: acupuncture |
| B | Experimental | staging acupuncture and moxibustion for treating Bell's Palsy Receives: Other: acupuncture and moxibustion |
| C | Experimental | staging electroacupuncture for treating Bell's Palsy Receives: Other: electroacupuncture |
| D | Experimental | staging acupuncture along Yangming musculature for treating Bell's Palsy Receives: Other: acupuncture along yangming tendons |
| E | Experimental | non-staging acupuncture for treating Bell's Palsy Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann scale （Global Score）
Measured: a week
Secondary outcomes (4)
Classification Score Of Facial Paralysis Degree
Measured: a week
Facial Disability Index
Measured: a week
WHOQOL-BREF scale
Measured: two week
House-Brackmann scale （Regional Score）
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startOct 2006
- Primary completionSep 2009
- Study completionSep 2009
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Ying Li, Dr., Principal investigator, Acupuncture&Moxibustion college of chengdu TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608660
- Sponsor's protocol ID
- 2006BAI12B03
- Status last verified
- Sep 2009
- First submitted
- 4 Jan 2008
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
PubMed 21435214
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying of Acupuncture for Bell's Palsy According to Different Stages
- ClinicalTrials.gov ID
- NCT00608660
- Acronym / sponsor ID
- 2006BAI12B03
- Conditions
- Bell's Palsy
- Keywords
- Peripheral Facial Paralysis, Acupuncture, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Feb 2008 (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 purpose of this trial will certify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy
Detailed description
The result of this trial (available in 2009) aims to testify the efficacy of using staging acupuncture and moxibustion to treat Bell's Palsy, and to approach a best acupuncture treatment among these five different methods for treating Bell's Palsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: acupuncturestaging acupuncture for treating Bell's Palsy |
| B | Experimental | Other: acupuncture and moxibustionstaging acupuncture and moxibustion for treating Bell's Palsy |
| C | Experimental | Other: electroacupuncturestaging electroacupuncture for treating Bell's Palsy |
| D | Experimental | Other: acupuncture along yangming tendonsstaging acupuncture along Yangming musculature for treating Bell's Palsy |
| E | Experimental | Other: acupuncturenon-staging acupuncture for treating Bell's Palsy |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patients who meet the diagnosis, stages, location criteria
- the first time to onset the disease
- between 1 and 70 days with the onset time of facial palsy
- on one side of the face paralysis
- between 15 and 70 years old with the onset age of facial palsy
Key exclusion criteria (6 listed)
- facial palsy caused by other disease, such as infectivity multiple radiculitis, tumor which offend temporal bone, cerebral trauma
- facial palsy combine diabetes, the severe disease of heart vessel, cerebral vessel, liver, kidney, lung, and psychosis
- patient with Hunt's syndrome
- patient with facial spasm
- pregnant women or women in lactation
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 |
|---|---|---|
| acupuncturestaging acupuncture | Other | A |
| acupuncture and moxibustionstaging acupuncture and moxibustion | Other | B |
| electroacupuncturestaging electroacupuncture | Other | C |
| acupuncture along yangming tendonsstaging acupuncture along Yangming musculature | Other | D |
| acupuncturenon-staging acupuncture | Other | E |
Primary outcome
House-Brackmann scale （Global Score）
Time frame: a week
4 secondary outcomes
Classification Score Of Facial Paralysis Degree
Time frame: a week
Facial Disability Index
Time frame: a week
WHOQOL-BREF scale
Time frame: two week
House-Brackmann scale （Regional Score）
Time frame: a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
- Derived from this study: PubMed 21435214Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
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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.
Ying Li, Dr. principal investigator
Acupuncture&Moxibustion college of chengdu TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture, acupuncture and moxibustion and electroacupuncture in people with Bell's Palsy, run by Chengdu University of Traditional Chinese Medicine 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 17 Sep 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann scale （Global Score） (time frame: a week). 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 NCT00608660, 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 17 Sep 2009.