Acupuncture and Auditory Evoked Potentials

Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Evoked Potentials
• Intervention / Treatment: Behavioral: Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Ernst Moritz Arndt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Latencies of Auditory Evoked Potentials	before acupuncture stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain	30 min

Collaborators and Investigators

• Sponsor: Taras Usichenko
• Investigators: Study Chair: Taras I Usichenko, M.D., Ernst Moritz Arndt University; Principal Investigator: Reinhard Schmidt, M.D., Ernst Moritz Arndt University

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: June 3, 2006
• First Submitted That Met QC Criteria: June 3, 2006
• First Posted (Estimate): June 6, 2006

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: III UV 12/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided