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

Healthy Individuals Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876160
• Other study ID #: U1111-1143-6220
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: June 8, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Other:
• Transcutaneous electrical nerve stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No