Trial Outcomes & Findings for Acupuncture and Auditory Evoked Potentials (NCT NCT00333606)

NCT ID: NCT00333606

Last Updated: 2019-10-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: before acupuncture stimulation
• Results posted on: 2019-10-22

Participant Flow

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.

Participant milestones

Measure	Sham, Then Verum Acupuncture Stimulation was applied to sham acupuncture point	Verum, Then Sham Acupuncture Stimulation was applied to verum acupuncture point
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acupuncture and Auditory Evoked Potentials

Baseline characteristics by cohort

Measure	Verum, Then Sham Acupuncture n=30 Participants verum acupuncture means stimulation of specific acupuncture points	Sham, Then Verum Acupuncture n=30 Participants Sham acupuncture means stimulation of non-specific points	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Germany	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: before acupuncture stimulation

Outcome measures

Measure	Verum Acupuncture n=60 Participants Acupuncture of specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session	Sham Acupuncture n=60 Participants Acupuncture of non-specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session
Latencies of Auditory Evoked Potentials	255 ms Standard Deviation 55	255 ms Standard Deviation 55

SECONDARY outcome

Timeframe: 30 min

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

Outcome measures

Measure	Verum Acupuncture n=60 Participants Acupuncture of specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session	Sham Acupuncture n=60 Participants Acupuncture of non-specific acupuncture points Acupuncture: Body acupuncture of 1 specific point per trial session
Pain Intensity	40 mm Interval 10.0 to 60.0	20 mm Interval 10.0 to 30.0

Adverse Events

Verum Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Taras Usichenko, director of the trial

Ernst Moritz Arndt University of Greifswald

Phone: +493834865828

Email: taras@uni-greifswald.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place