Evoked Potentials, Healthy Volunteers
Conditions
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
Interventions
BEHAVIORALAcupuncture
Body acupuncture of 1 specific point per trial session
Sponsors
Taras Usichenko
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Latencies of Auditory Evoked Potentials | before acupuncture stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 30 min | Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain |
Countries
Germany
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Verum, Then Sham Acupuncture verum acupuncture means stimulation of specific acupuncture points | 30 |
| Sham, Then Verum Acupuncture Sham acupuncture means stimulation of non-specific points | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Verum, Then Sham Acupuncture | Sham, Then Verum Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Germany | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Latencies of Auditory Evoked Potentials
Time frame: before acupuncture stimulation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Verum Acupuncture | Latencies of Auditory Evoked Potentials | 255 ms | Standard Deviation 55 |
| Sham Acupuncture | Latencies of Auditory Evoked Potentials | 255 ms | Standard Deviation 55 |
Secondary
Pain Intensity
Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain
Time frame: 30 min
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Verum Acupuncture | Pain Intensity | 40 mm |
| Sham Acupuncture | Pain Intensity | 20 mm |