Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy

NCT ID: NCT00685789

Last Updated: 2011-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bell's Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture with Deqi

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.

Group Type EXPERIMENTAL

acupuncture, deqi

Intervention Type DEVICE

Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.

Acupuncture without Deqi

Needles were simply inserted and retained for 30 min, without any other stimulation.

Group Type ACTIVE_COMPARATOR

acupuncture Non-manipulation

Intervention Type DEVICE

After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture, deqi

Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.

Intervention Type DEVICE

acupuncture Non-manipulation

After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Manipulation Non-Manipulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
2. aged 18 to 65 years.

Exclusion Criteria

1. illiterate;
2. the facial paralysis is caused by herpes zoster;
3. recurrent facial paralysis;
4. noticeable asymmetry of the face before the illness which may affect the evaluation;
5. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Xiangyang No.1 People's Hospital

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Yichang Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Wuhan General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wei Wang

Department of Neurology of Tongji Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wei Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23439629 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006CB504502

Identifier Type: -

Identifier Source: org_study_id