Analysis of Sensory and Motor Thresholds During Transcutaneous Electrical Stimulation in Different Sexes and Ages

June 8, 2013 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
The sensory and motor perception thresholds can influence the therapeutic effects of Transcutaneous Electrical Nerve Stimulation. This study aimed to determine the threshold of sensory perception and the threshold of motor response in young and elderly subjects of both sexes. Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects. Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was identified as the first sensation of increased current intensity and the threshold of motor response as the minimum muscle contraction detected. The results were submitted to ANOVA test, followed by the Tukey test, with a significance level of 5%.

Study Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy individuals

Exclusion Criteria:

  • not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in areas to be studied.
  • are not in menstrual period or a week before it
  • not be making use of drugs that affect the nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: threshold of sensory perception
Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects. Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers. The threshold of sensory perception was identified as the first sensation of increased current intensity and the threshold of motor response as the minimum muscle contraction detected.
Other: Transcutaneous electrical nerve stimulation
Experimental: threshold of motor response
Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects. Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers. The threshold of motor response as the minimum muscle contraction detected.
Other: Transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analysis of sensory thresholds
Time Frame: 1 years
A pulse generator was used for data collection, with constant current intensity, and the following parameters were used for current stimulation: square biphasic wave, and pulse-width varying in 20, 50, 100, 200,300, 500, 1000 and 3000µs, at a frequency of 5 or 50Hz. During the procedure, the volunteers remained seated, with the forearm in supination, resting on a table. The tests always initiated with 20µs pulse-width, with high intensity until the threshold of sensory perception were reached. At this point, the intensity was reset and the procedure began again, followed by the next pulse duration, progressively evolving up to 3000µs and repeated three times with a 10-minute interval between the tests. The procedures were carried out with a 72 hour minimum interval for different frequencies.
1 years
Analysis of Motor thresholds
Time Frame: 1 years
A pulse generator was used for data collection, with constant current intensity, and the following parameters were used for current stimulation: square biphasic wave, and pulse-width varying in 20, 50, 100, 200,300, 500, 1000 and 3000µs, at a frequency of 5 or 50Hz. During the procedure, the volunteers remained seated, with the forearm in supination, resting on a table. The tests always initiated with 20µs pulse-width, with high intensity until the threshold of motor response were reached. At this point, the intensity was reset and the procedure began again, followed by the next pulse duration, progressively evolving up to 3000µs and repeated three times with a 10-minute interval between the tests. The procedures were carried out with a 72 hour minimum interval for different frequencies.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1143-6220

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