NCT01876160

Brief Summary

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%.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

May 27, 2013

Last Update Submit

June 8, 2013

Conditions

Outcome Measures

Primary Outcomes (2)

  • Analysis of sensory thresholds

    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

    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

Study Arms (2)

threshold of sensory perception

EXPERIMENTAL

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

threshold of motor response

EXPERIMENTAL

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

Interventions

threshold of motor responsethreshold of sensory perception

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 12, 2013

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 12, 2013

Record last verified: 2013-06