Acupuncture With Deqi And Psychological Effects in Treatment of Bell's Palsy (ADAPT)
The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy|
- House-Brackmann scale (HBS) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]
- facial disability index (FDI) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]
- World Health Organization Quality of Life-BREF(WHOQOL-BREF) [ Time Frame: 6 months after onset of symptoms ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
Device: acupuncture, deqi
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
Other Name: Manipulation
Active Comparator: Acupuncture without Deqi
Needles were simply inserted and retained for 30 min, without any other stimulation.
Device: acupuncture Non-manipulation
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
Other Name: Non-Manipulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685789
|Institute of Integrated Traditional Chinese and Western Medicine|
|Wuhan, Hubei, China, 430030|
|Principal Investigator:||Wei Wang, doctor||Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology|