Acupuncture and Auditory Evoked Potentials

NCT ID: NCT00333606

Last Updated: 2019-10-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Evoked Potentials Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verum acupuncture

Acupuncture of specific acupuncture points

Group Type EXPERIMENTAL

Acupuncture

Intervention Type BEHAVIORAL

Body acupuncture of 1 specific point per trial session

Sham acupuncture

Acupuncture of non-specific acupuncture points

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type BEHAVIORAL

Body acupuncture of 1 specific point per trial session

Interventions

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Acupuncture

Body acupuncture of 1 specific point per trial session

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taras Usichenko

OTHER

Sponsor Role lead

Responsible Party

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Taras Usichenko

Dr. Taras Usichenko

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Taras I Usichenko, M.D.

Role: STUDY_CHAIR

Ernst Moritz Arndt University

Reinhard Schmidt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ernst Moritz Arndt University

Locations

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Ernst Moritz Arndt University

Greifswald, , Germany

Site Status

Countries

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Germany

Other Identifiers

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III UV 12/06

Identifier Type: -

Identifier Source: org_study_id

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