Acupuncture and Auditory Evoked Potentials

• Sponsor: Taras Usichenko (Other)
• Overall Status: Completed
• CT.gov ID: NCT00333606
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 49.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2005
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Latencies of Auditory Evoked Potentials [before acupuncture stimulation]

Secondary Outcome Measures

1. Pain Intensity [30 min]

   Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ernst Moritz Arndt University	Greifswald		Germany	17475

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taras Usichenko, Dr. Taras Usichenko, University Medicine Greifswald
• ClinicalTrials.gov Identifier: NCT00333606
• Other Study ID Numbers: III UV 12/06
• First Posted: Jun 6, 2006
• Last Update Posted: Oct 22, 2019
• Last Verified: Apr 1, 2017

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

Study Results

Participant Flow

Pre-assignment Detail	This was the crossover study with 60 participants. Each participant underwent 2 conditions: verum and sham acupuncture within an interval of at least one week.

Arm/Group Title	Sham, Then Verum Acupuncture	Verum, Then Sham Acupuncture
Arm/Group Description	Stimulation was applied to sham acupuncture point	Stimulation was applied to verum acupuncture point
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Verum, Then Sham Acupuncture	Sham, Then Verum Acupuncture	Total
Arm/Group Description	verum acupuncture means stimulation of specific acupuncture points	Sham acupuncture means stimulation of non-specific points	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	20 66.7%	20 66.7%	40 66.7%
Male	10 33.3%	10 33.3%	20 33.3%
Region of Enrollment (participants) [Number]
Germany	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Latencies of Auditory Evoked Potentials
Time Frame	before acupuncture stimulation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Verum Acupuncture	Sham Acupuncture
Arm/Group Description	Acupuncture of specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session	Acupuncture of non-specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session
Measure Participants	60	60
Mean (Standard Deviation) [ms]	255 (55)	255 (55)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sham Acupuncture	Verum Acupuncture
Arm/Group Description	Sham acupuncture means stimulation of non-specific points	Acupuncture needles applied to specific acupuncture points
Measure Participants	60	60
Median (Inter-Quartile Range) [mm]	40	20

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Verum Acupuncture		Sham Acupuncture
Arm/Group Description	verum acupuncture means stimulation of specific acupuncture points		Sham acupuncture means stimulation of non-specific points
All Cause Mortality
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Serious Adverse Events
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Verum Acupuncture		Sham Acupuncture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.