NCT00333606

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

June 3, 2006

Results QC Date

February 25, 2011

Last Update Submit

October 18, 2019

Conditions

Evoked PotentialsHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Latencies of Auditory Evoked Potentials

    before acupuncture stimulation

Secondary Outcomes (1)

  • Pain Intensity

    30 min

Study Arms (2)

Verum acupuncture

EXPERIMENTAL

Acupuncture of specific acupuncture points

Behavioral: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Acupuncture of non-specific acupuncture points

Behavioral: Acupuncture

Interventions

AcupunctureBEHAVIORAL

Body acupuncture of 1 specific point per trial session

Sham acupunctureVerum acupuncture

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ernst Moritz Arndt University

Greifswald, 17475, Germany

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Taras Usichenko, director of the trial
Organization
Ernst Moritz Arndt University of Greifswald
taras@uni-greifswald.de
+493834865828

Study Officials

  • Taras I Usichenko, M.D.

    Ernst Moritz Arndt University

    STUDY CHAIR

  • Reinhard Schmidt, M.D.

    Ernst Moritz Arndt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Taras Usichenko

Study Record Dates

First Submitted

June 3, 2006

First Posted

June 6, 2006

Study Start

January 1, 2005

Primary Completion

February 1, 2007

Study Completion

March 1, 2009

Last Updated

October 22, 2019

Results First Posted

October 22, 2019

Record last verified: 2017-04

Locations

DE(1)