Trial Outcomes & Findings for Local Effects of Acupuncture and Nerve Conduction Studies (NCT NCT03036657)
NCT ID: NCT03036657
Last Updated: 2023-10-10
Results Overview
The median change plus standard deviation when the median nerve was treated and CDT was measured in the sensory distribution of the median nerve. The CDT is measured in CASE IV - specific units named Just Noticeable Difference (JND). The CASE IV System uses a set of 25 standardized vibratory and thermal stimulation levels for patient testing and analysis. These 25 levels are termed "Just Noticeable Differences" or "JNDs," and are similar to decibels. The concept of a JND is based on the fact that a sensitive person can detect fine differences between two levels of stimulation, whereas an insensitive person cannot. Because differences of less than one JND are difficult to distinguish, one JND is the smallest difference presented to patients. Stimuli based on the JND scale can be used to test patients very efficiently and quickly, without compromising the significance of the clinical result.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Week 1, Week 2
Results posted on
2023-10-10
Participant Flow
Participant milestones
| Measure |
Manual Acupuncture
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND
|
High-Frequency Electroacupuncture
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Local Effects of Acupuncture and Nerve Conduction Studies
Baseline characteristics by cohort
| Measure |
Manual Acupuncture
n=20 Participants
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min AND High-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
High-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min AND High-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Continuous
|
52.05 Years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
48.90 Years
STANDARD_DEVIATION 17.22 • n=7 Participants
|
55.50 Years
STANDARD_DEVIATION 13.92 • n=5 Participants
|
52.15 Years
STANDARD_DEVIATION 14.92 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Median Cold Detection Threshold
|
8.0 JND (just noticeable difference)
STANDARD_DEVIATION 2.3 • n=5 Participants
|
8.6 JND (just noticeable difference)
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.8 JND (just noticeable difference)
STANDARD_DEVIATION 1.6 • n=5 Participants
|
8.2 JND (just noticeable difference)
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Ulnar Cold Detection Threshold
|
10.1 JND (Just Noticeable Difference)
STANDARD_DEVIATION 2.2 • n=5 Participants
|
10.8 JND (Just Noticeable Difference)
STANDARD_DEVIATION 2.3 • n=7 Participants
|
10.2 JND (Just Noticeable Difference)
STANDARD_DEVIATION 2.0 • n=5 Participants
|
10.4 JND (Just Noticeable Difference)
STANDARD_DEVIATION 2.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 2The median change plus standard deviation when the median nerve was treated and CDT was measured in the sensory distribution of the median nerve. The CDT is measured in CASE IV - specific units named Just Noticeable Difference (JND). The CASE IV System uses a set of 25 standardized vibratory and thermal stimulation levels for patient testing and analysis. These 25 levels are termed "Just Noticeable Differences" or "JNDs," and are similar to decibels. The concept of a JND is based on the fact that a sensitive person can detect fine differences between two levels of stimulation, whereas an insensitive person cannot. Because differences of less than one JND are difficult to distinguish, one JND is the smallest difference presented to patients. Stimuli based on the JND scale can be used to test patients very efficiently and quickly, without compromising the significance of the clinical result.
Outcome measures
| Measure |
Manual Acupuncture
n=20 Participants
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND
|
High-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min
|
|---|---|---|---|
|
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated
|
0.73 JND (just noticeable difference)
Standard Deviation 1.527
|
-0.195 JND (just noticeable difference)
Standard Deviation 1.698
|
0.865 JND (just noticeable difference)
Standard Deviation 2.021
|
PRIMARY outcome
Timeframe: Week 1, Week 2This is the mean change plus standard deviation in CDT in the sensory distribution of the ulnar never when the median nerve is treated. The CDT is measured in CASE IV - specific units named Just Noticeable Difference (JND). The CASE IV System uses a set of 25 standardized vibratory and thermal stimulation levels for patient testing and analysis. These 25 levels are termed "Just Noticeable Differences" or "JNDs," and are similar to decibels. The concept of a JND is based on the fact that a sensitive person can detect fine differences between two levels of stimulation, whereas an insensitive person cannot. Because differences of less than one JND are difficult to distinguish, one JND is the smallest difference presented to patients. Stimuli based on the JND scale can be used to test patients very efficiently and quickly, without compromising the significance of the clinical result.
Outcome measures
| Measure |
Manual Acupuncture
n=20 Participants
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND
|
High-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min
|
|---|---|---|---|
|
Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Median Nerve is Treated
|
0.215 JND
Standard Deviation 1.732
|
0.07 JND
Standard Deviation 1.264
|
0.375 JND
Standard Deviation 1.064
|
PRIMARY outcome
Timeframe: Week 1, Week 2This is the mean change plus standard deviation in the sensory territory of the Median nerve when the Ulnar nerve was treated.
Outcome measures
| Measure |
Manual Acupuncture
n=20 Participants
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND
|
High-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min
|
|---|---|---|---|
|
Change in Median Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated
|
-0.37 JND
Standard Deviation 1.309
|
0.23 JND
Standard Deviation 1.358
|
0.23 JND
Standard Deviation 1.627
|
PRIMARY outcome
Timeframe: Week 1, Week 2This is the mean plus standard deviation change in CDT in the sensory territory of the ulnar nerve when the ulnar nerve is treated.
Outcome measures
| Measure |
Manual Acupuncture
n=20 Participants
Device:
Sterile single-use MAC acupuncture needles - 0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea
Used for Intervention:
Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
MAC acupuncture needles: Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min
|
Low-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
Low-frequency Continuous Electroacupuncture (2Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
Low-frequency Continuous Electroacupuncture - 4 Hz to PC3, PC5 or HT3, HT4 for 20 min AND
|
High-Frequency Electroacupuncture
n=20 Participants
Device:
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA
Used for Intervention:
High-frequency Continuous Electroacupuncture (100 Hz) to PC3, PC5 or HT3, HT4 for 20 min
Electrostimulator 6c.Pro, Pantheon Research, Venice, CA: Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
Used for Interventions:
High-frequency Continuous Electroacupuncture - 100 Hz to PC3, PC5 or HT3, HT4 for 20 min
|
|---|---|---|---|
|
Change in Ulnar Cold Detection Threshold (CDT) Post-acupuncture Compared to Pre-acupuncture When the Ulnar Nerve is Treated
|
-0.68 JND
Standard Deviation 1.626
|
0.30 JND
Standard Deviation 1.182
|
0.405 JND
Standard Deviation 0.990
|
Adverse Events
Manual Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-Frequency Electroacupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Frequency Electroacupuncture
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
Alexandra Dimitrova, PI
Oregon Health & Science University
Phone: 503-494-0766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place