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Electrical Currents on Hypoalgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950728
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Fabio Massao Matuzawa, Paulista University

Brief Summary:
The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Device: Interferential current Device: Aussie Current Device: TENS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypoalgesic Effect of Low Frequency and Burst Modulated Alternating Currents on Healthy Individuals.
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : January 23, 2018

Arm Intervention/treatment
No Intervention: Control group
This group will not receive electrical stimulation. Volunteers will rest during 30 minutes.
Active Comparator: Interferential current group
Interferential current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: Interferential current
Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.

Active Comparator: TENS Group
TENS will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: TENS
TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.

Active Comparator: Aussie current group
Aussie current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: Aussie Current
Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.




Primary Outcome Measures :
  1. Pressure Pain Threshold [ Time Frame: Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation. ]
    Pressure Pain Threshold will be measured using a digital pressure algometer SOMEDIC type II. The applied force will be measured in Newton (N).


Secondary Outcome Measures :
  1. Sensory Discomfort [ Time Frame: 15 and 30 minutes after the beginning of electrical stimulation. ]
    Sensory Discomfort will be measured using a 10 cm visual analogue scale (VAS). The degree of discomfort will be measured in centimeters (cm).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • health adults

Exclusion Criteria:

  • injury to nerves of the upper limbs, pain, pregnancy, chronic diseases, cardiac pacemaker, epilepsy, allergy to the electrode used, use of pain medication, skin lesions or lack of sensitivity in the areas of electrode placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950728


Locations
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Brazil
CPA Pompéia UNIP
São Paulo, Brazil, 17580-970
Sponsors and Collaborators
Fabio Massao Matuzawa

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabio Massao Matuzawa, Physical Therapy Student, Paulista University
ClinicalTrials.gov Identifier: NCT01950728    
Other Study ID Numbers: 14571013.1.0000.5512
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fabio Massao Matuzawa, Paulista University:
volunteers
18 to 65 years
Males and Females