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Acupuncture and Auditory Evoked Potentials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00333606
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Taras Usichenko, University Medicine Greifswald

Brief Summary:
To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points

Condition or disease Intervention/treatment Phase
Evoked Potentials Healthy Volunteers Behavioral: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study
Study Start Date : January 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Verum acupuncture
Acupuncture of specific acupuncture points
Behavioral: Acupuncture
Body acupuncture of 1 specific point per trial session

Sham Comparator: Sham acupuncture
Acupuncture of non-specific acupuncture points
Behavioral: Acupuncture
Body acupuncture of 1 specific point per trial session




Primary Outcome Measures :
  1. Latencies of Auditory Evoked Potentials [ Time Frame: before acupuncture stimulation ]

Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: 30 min ]
    Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers aged 20-40 years
  2. Physical status I according to American Society of Anesthesiologists (ASA) classification
  3. No history of nervous or psychiatric disease
  4. Normal audiogram before the study
  5. No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol
  6. No local infection at the site of acupuncture
  7. Volunteers who have given informed consent

Exclusion Criteria:

  1. Pregnant or nursing females.
  2. History of peripheral neuropathy
  3. Abnormal skin conditions (infection, scars, psoriasis, eczema)
  4. Inflamed site of acupuncture within 1 week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333606


Locations
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Germany
Ernst Moritz Arndt University
Greifswald, Germany, 17475
Sponsors and Collaborators
Taras Usichenko
Investigators
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Study Chair: Taras I Usichenko, M.D. Ernst Moritz Arndt University
Principal Investigator: Reinhard Schmidt, M.D. Ernst Moritz Arndt University

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Responsible Party: Taras Usichenko, Dr. Taras Usichenko, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT00333606    
Other Study ID Numbers: III UV 12/06
First Posted: June 6, 2006    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided