Trial Outcomes & Findings for Direct Current Cathode and Anode Effects and Changes in Handgrip Strength. Evaluation Through a Dynamometer Test (NCT NCT02884427)
NCT ID: NCT02884427
Last Updated: 2018-10-09
Results Overview
The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Control
Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
|
Cathode Stimulation
Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
|
Anode Stimulation
Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
52
|
|
Overall Study
COMPLETED
|
50
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Direct Current Cathode and Anode Effects and Changes in Handgrip Strength. Evaluation Through a Dynamometer Test
Baseline characteristics by cohort
| Measure |
Cathode Stimulation
n=48 Participants
Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
|
Anode Stimulation
n=52 Participants
Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
|
Control
n=50 Participants
Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
126 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 3 • n=93 Participants
|
23 years
STANDARD_DEVIATION 2 • n=4 Participants
|
22 years
STANDARD_DEVIATION 3 • n=27 Participants
|
23 years
STANDARD_DEVIATION 3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
63 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
87 Participants
n=483 Participants
|
|
Region of Enrollment
Chile
|
48 participants
n=93 Participants
|
52 participants
n=4 Participants
|
50 participants
n=27 Participants
|
150 participants
n=483 Participants
|
|
Body Mass Index (BMI)
|
24 kg/m^2
STANDARD_DEVIATION 3 • n=93 Participants
|
24 kg/m^2
STANDARD_DEVIATION 3 • n=4 Participants
|
25 kg/m^2
STANDARD_DEVIATION 5 • n=27 Participants
|
24 kg/m^2
STANDARD_DEVIATION 3 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Outcome measures
| Measure |
Cathode Stimulation
n=48 Participants
Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
|
Anode Stimulation
n=52 Participants
Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
|
Control
n=50 Participants
Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
|
|---|---|---|---|
|
Difference of Maximum Grip Strength
|
03 Kilograms (Kg)
Standard Deviation 5
|
0 Kilograms (Kg)
Standard Deviation 4
|
-02 Kilograms (Kg)
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.The difference in maximum grip strength for males is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the men of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Outcome measures
| Measure |
Cathode Stimulation
n=30 Participants
Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
|
Anode Stimulation
n=31 Participants
Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
|
Control
n=26 Participants
Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
|
|---|---|---|---|
|
Difference of Maximum Grip Strength for Males
|
1 Kilograms (Kg)
Interval -3.0 to 4.0
|
0 Kilograms (Kg)
Interval 0.0 to 2.0
|
0.5 Kilograms (Kg)
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.The difference in maximum grip strength for females is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the women of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.
Outcome measures
| Measure |
Cathode Stimulation
n=18 Participants
Group that is involved with the (black) negative electrode seeking the polar effect of nervous increased excitability and conductivity with the current application.
Cathode stimulation: Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
|
Anode Stimulation
n=21 Participants
Group that is involved with the (red) positive electrode seeking the polar effect of nervous excitability and conductivity decreased with the current application.
Anode stimulation: Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
|
Control
n=24 Participants
Group that will be placed electrotherapy without operation, but only installation. Patients in this group will see the team work but it will not be delivering current.
Placebo: Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
|
|---|---|---|---|
|
Difference of Maximum Grip Strength for Females
|
-0.3 Kilograms (Kg)
Standard Deviation 5
|
-0.8 Kilograms (Kg)
Standard Deviation 4
|
-0.8 Kilograms (Kg)
Standard Deviation 4
|
Adverse Events
Cathode Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anode Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Professor Hernán Andrés de la Barra O., DC,PT,Mg
Universidad Andrés Bello
Phone: 56226618402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place