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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum acupuncture | Experimental | Acupuncture of specific acupuncture points |
|
| Sham acupuncture | Sham Comparator | Acupuncture of non-specific acupuncture points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Behavioral | Body acupuncture of 1 specific point per trial session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Latencies of Auditory Evoked Potentials | before acupuncture stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain | 30 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taras I Usichenko, M.D. | Ernst Moritz Arndt University | Study Chair |
| Reinhard Schmidt, M.D. | Ernst Moritz Arndt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ernst Moritz Arndt University | Greifswald | 17475 | Germany |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham, Then Verum Acupuncture | Stimulation was applied to sham acupuncture point |
| FG001 | Verum, Then Sham Acupuncture | Stimulation was applied to verum acupuncture point |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy volunteers
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum, Then Sham Acupuncture | verum acupuncture means stimulation of specific acupuncture points |
| BG001 | Sham, Then Verum Acupuncture | Sham acupuncture means stimulation of non-specific points |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Latencies of Auditory Evoked Potentials | Posted | Mean | Standard Deviation | ms | before acupuncture stimulation |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum Acupuncture | verum acupuncture means stimulation of specific acupuncture points |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taras Usichenko, director of the trial | Ernst Moritz Arndt University of Greifswald | +493834865828 | taras@uni-greifswald.de |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pain Intensity | Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain | Posted | Median | Inter-Quartile Range | mm | 30 min |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Sham Acupuncture | Sham acupuncture means stimulation of non-specific points | 0 | 60 | 0 | 60 | 0 | 60 |
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