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

Overview

The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.

Full Title of Study: “Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell’s Palsy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 2010

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.

Interventions

  • Device: acupuncture, deqi
    • Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the deqi sensation.
  • Device: acupuncture Non-manipulation
    • After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Acupuncture without Deqi
    • Needles were simply inserted and retained for 30 min, without any other stimulation.

Clinical Trial Outcome Measures

Primary Measures

  • House-Brackmann scale (HBS)
    • Time Frame: 6 months after onset of symptoms

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Huazhong University of Science and Technology
  • Collaborator
    • Hubei Hospital of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wei Wang, Department of Neurology of Tongji Hospital – Huazhong University of Science and Technology
  • Overall Official(s)
    • Wei Wang, doctor, Principal Investigator, Tongji Hospital

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