Bell's PalsyADAPTNCT00685789
Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy
A study testing acupuncture, deqi and acupuncture Non-manipulation in people with Bell's Palsy, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- acupuncture, deqi and acupuncture Non-manipulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Dec 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
- aged 18 to 65 years.
Who cannot join
- illiterate;
- the facial paralysis is caused by herpes zoster;
- recurrent facial paralysis;
- noticeable asymmetry of the face before the illness which may affect the evaluation;
- history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Integrated Traditional Chinese and Western Medicine
Wuhan, Hubei, 430030
About this study
Official title: Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.
Read the detailed description
Through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. However,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.This study will adopt a series of international practice scales ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for Bell's Palsy.
- Conditions
- Bell's Palsy
- Being tested
- acupuncture, deqi, acupuncture Non-manipulation
- Keywords
- Bell's palsy，deqi，acupuncture, neuropsychology
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture, deqiDevice
Also called Manipulation
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
acupuncture Non-manipulationDevice
Also called Non-Manipulation
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture with Deqi | Experimental | Needles were inserted and manipulated manually using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation of soreness, numbness, fullness, aching, cool, warmth, heaviness and radiating sensation (Deqi) occurred. The needles were retained for 30 min. Receives: Device: acupuncture, deqi |
| Acupuncture without Deqi | Active comparator | Needles were simply inserted and retained for 30 min, without any other stimulation. Receives: Device: acupuncture Non-manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann scale (HBS)
Measured: 6 months after onset of symptoms
Secondary outcomes (2)
facial disability index (FDI)
Measured: 6 months after onset of symptoms
World Health Organization Quality of Life-BREF(WHOQOL-BREF)
Measured: 6 months after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionDec 2010
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 Huazhong University of Science and TechnologyThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, Xiangyang No.1 People's Hospital, Renmin Hospital of Wuhan University, Fudan University, Second Affiliated Hospital of Zhengzhou University, Yichang Hospital of Traditional Chinese Medicine, The First Hospital of Hebei Medical University, Wuhan General Hospital of Guangzhou Military Command
- Responsible party
- Principal investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685789
- Sponsor's protocol ID
- 2006CB504502
- Acronym
- ADAPT
- Status last verified
- Jun 2008
- First submitted
- 23 May 2008
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013 Apr 2;185(6):473-9. doi: 10.1503/cmaj.121108. Epub 2013 Feb 25.
PubMed 23439629
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
- ClinicalTrials.gov ID
- NCT00685789
- Acronym / sponsor ID
- ADAPT / 2006CB504502
- Conditions
- Bell's Palsy
- Keywords
- Bell's palsy，deqi，acupuncture, neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, Xiangyang No.1 People's Hospital, Renmin Hospital of Wuhan University, Fudan University, Second Affiliated Hospital of Zhengzhou University, Yichang Hospital of Traditional Chinese Medicine, The First Hospital of Hebei Medical University, Wuhan General Hospital of Guangzhou Military Command
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 May 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 study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.
Detailed description
Through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. However,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.This study will adopt a series of international practice scales ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for Bell's Palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture with Deqi | Experimental | Device: acupuncture, deqiNeedles were inserted and manipulated manually using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation of soreness, numbness, fullness, aching, cool, warmth, heaviness and radiating sensation (Deqi) occurred. The needles were retained for 30 min. |
| Acupuncture without Deqi | Active comparator | Device: acupuncture Non-manipulationNeedles were simply inserted and retained for 30 min, without any other stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
- aged 18 to 65 years.
Key exclusion criteria (5 listed)
- illiterate;
- the facial paralysis is caused by herpes zoster;
- recurrent facial paralysis;
- noticeable asymmetry of the face before the illness which may affect the evaluation;
- history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.
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 |
|---|---|---|
| acupuncture, deqiAlso: ManipulationImmediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation. | Device | Acupuncture with Deqi |
| acupuncture Non-manipulationAlso: Non-ManipulationAfter insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes. | Device | Acupuncture without Deqi |
Primary outcome
House-Brackmann scale (HBS)
Time frame: 6 months after onset of symptoms
2 secondary outcomes
facial disability index (FDI)
Time frame: 6 months after onset of symptoms
World Health Organization Quality of Life-BREF(WHOQOL-BREF)
Time frame: 6 months after onset of symptoms
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 29 Sep 2011.
- Derived from this study: PubMed 23439629Xu SB, Huang B, Zhang CY, Du P, Yuan Q, Bi GJ, Zhang GB, Xie MJ, Luo X, Huang GY, Wang W. Effectiveness of strengthened stimulation during acupuncture for the treatment of Bell palsy: a randomized controlled trial. CMAJ. 2013 Apr 2;185(6):473-9. doi: 10.1503/cmaj.121108. Epub 2013 Feb 25.
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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.
Wei Wang, doctor principal investigator
Tongji 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 acupuncture, deqi and acupuncture Non-manipulation in people with Bell's Palsy, run by Huazhong University of Science and Technology 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 2 inclusion and 5 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 29 Sep 2011. 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 (HBS) (time frame: 6 months after onset of symptoms). 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 NCT00685789, 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 29 Sep 2011.