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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

Tracking Information
First Submitted Date  ICMJE September 23, 2013
First Posted Date  ICMJE September 25, 2013
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE September 25, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Sensory Discomfort [ Time Frame: 15 and 30 minutes after the beginning of electrical stimulation. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Currents on Hypoalgesia
Official Title  ICMJE Hypoalgesic Effect of Low Frequency and Burst Modulated Alternating Currents on Healthy Individuals.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Interferential current
  • 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.
    Intervention: Device: TENS
  • 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.
    Intervention: Device: Aussie Current
Publications * Rampazo da Silva ÉP, da Silva VR, Bernardes AS, Matuzawa FM, Liebano RE. Study protocol of hypoalgesic effects of low frequency and burst-modulated alternating currents on healthy individuals. Pain Manag. 2018 Mar;8(2):71-77. doi: 10.2217/pmt-2017-0058. Epub 2018 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
80
Actual Study Completion Date  ICMJE January 23, 2018
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950728
Other Study ID Numbers  ICMJE 14571013.1.0000.5512
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabio Massao Matuzawa, Paulista University
Study Sponsor  ICMJE Fabio Massao Matuzawa
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Paulista University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP