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Trial record 11 of 10334 for:    strength

Direct Current Cathode and Anode Effects and Changes in Handgrip Strength. Evaluation Through a Dynamometer Test

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ClinicalTrials.gov Identifier: NCT02884427
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : July 14, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Quiropraxia y Equilibrio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Handgrip Strength
Interventions Device: Cathode stimulation
Device: Anode stimulation
Device: Placebo
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cathode Stimulation Anode Stimulation Control
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 48 52 50
Completed 48 52 50
Not Completed 0 0 0
Arm/Group Title Cathode Stimulation Anode Stimulation Control Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 48 52 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 52 participants 50 participants 150 participants
<=18 years
7
  14.6%
6
  11.5%
11
  22.0%
24
  16.0%
Between 18 and 65 years
41
  85.4%
46
  88.5%
39
  78.0%
126
  84.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 52 participants 50 participants 150 participants
23  (3) 23  (2) 22  (3) 23  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 52 participants 50 participants 150 participants
Female
18
  37.5%
21
  40.4%
24
  48.0%
63
  42.0%
Male
30
  62.5%
31
  59.6%
26
  52.0%
87
  58.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 48 participants 52 participants 50 participants 150 participants
48 52 50 150
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 48 participants 52 participants 50 participants 150 participants
24  (3) 24  (3) 25  (5) 24  (3)
1.Primary Outcome
Title Difference of Maximum Grip Strength
Hide Description 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.
Time Frame Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cathode Stimulation Anode Stimulation Control
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 48 52 50
Mean (Standard Deviation)
Unit of Measure: Kilograms (Kg)
03  (5) 0  (4) -02  (5)
2.Secondary Outcome
Title Difference of Maximum Grip Strength for Males
Hide Description 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.
Time Frame Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cathode Stimulation Anode Stimulation Control
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 30 31 26
Median (Inter-Quartile Range)
Unit of Measure: Kilograms (Kg)
1
(-3 to 4)
0
(0 to 2)
0.5
(-2 to 2)
3.Secondary Outcome
Title Difference of Maximum Grip Strength for Females
Hide Description 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.
Time Frame Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cathode Stimulation Anode Stimulation Control
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 18 21 24
Mean (Standard Deviation)
Unit of Measure: Kilograms (Kg)
-0.3  (5) -0.8  (4) -0.8  (4)
Time Frame Serious and/or Other (Not Including Serious) adverse events were not collected/assessed.
Adverse Event Reporting Description Serious and/or Other (Not Including Serious) adverse events were not collected/assessed.
 
Arm/Group Title Cathode Stimulation Anode Stimulation Control
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Cathode Stimulation Anode Stimulation Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cathode Stimulation Anode Stimulation Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cathode Stimulation Anode Stimulation Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Hernán Andrés de la Barra O., DC,PT,Mg
Organization: Universidad Andrés Bello
Phone: 56226618402
EMail: quiropraxiayequilibrio@gmail.com
Publications:
Michelle H. Cameron, Physical Agents in Rehabilitations 2003, Elsevier. Cap. VIII, P, 220.
Schuster G, Marsden B: Treatment of pain by transcutaneous electric nerves stimulation in general practice, J Neurol Orthop Surg 1:137-1141, 1980.
Rodríguez Martin JM, Corrientes más utilizadas en la Electroterapia en Fisioterapia. Editorial Medica Panamericana, Cap II, P. 61- 86, 2000.
Petelenz TJ, Buttke C, Bonds LB, Lloyd JE, Beck RL, Stephens SC. Iontophoresis of dexamethasone: laboratory studies. J Controll Rel 1992;20:55-66.
Meijinde Faide R. Rodriguez .Villamil Fernandez JLy Teiro Vidal J. Corrientes Galvanicas En. Martinez Morillo M, Pastor Vega, y Sandra Portero F. Manual de Medicina Fisica Harcourt Brace España 1998 P150-68.
Calvo Arenilla JI, Rubio López I. Iontoforesis. Aplicaciones de la Iontoforesis. Electroestimulaciónaplicada. En: Meaños Melón E, Alonso Martínez M, Murga Rodríguez F, Pinsach Ametller J, et al. Vigo: Obradoiro Gráfico; 2003. p. 157-172.
Oh SY, Guy RH. Effects of iontophoresis on electrical properties of human skin in vivo. Int J Pharmacol 1995;124:137-42.
Layout table for additonal information
Responsible Party: Quiropraxia y Equilibrio
ClinicalTrials.gov Identifier: NCT02884427     History of Changes
Other Study ID Numbers: 60312061
First Submitted: August 15, 2016
First Posted: August 31, 2016
Results First Submitted: December 25, 2016
Results First Posted: July 14, 2017
Last Update Posted: October 9, 2018