Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 20, 2018

Primary Completion Date

December 9, 2019

Study Completion Date

December 9, 2019

Conditions
Healthy VolunteersHypertension, Essential
Interventions
DEVICE

Transcutaneous nervous electric stimulation (TENS)

TENS (Frequency 10 Hz or 100Hz /duration 200μs, Endophasys nms 0501® model, KLD Biosystems, Amparo, SP, Brazil) will be applied with intensity between 1 to 60 mA and the current will be adjusted every 5 minutes at the sensory threshold level muscle contraction or according to the tolerance to the stimulus informed by the volunteers. TENS will be applied in bilateral paravertebral region of C7 to T4 or long the brachial plexus and sciatic plexus.

DEVICE

Interferential electrical stimulation (IES)

The IES (Endophasys nms 0501®, KLD Biosystems, Amparo, SP, Brazil) will be applied in continuous mode with biphasic pulses. Bipolar electrodes with slope of 1/5/1. The rest of the parameters will be set to 4000 Hz, AMF of 100 Hz and the AMF variation of 25 Hz. The effect of the current will be adjusted by the intensity, it should produce paresthesia stimuli, without pain and below the motor threshold. Adhesive electrodes (MultiStick®, Axelgaard Manufacturing CO, Ltd, Fallbrook, CA, USA) will be housed in the paravertebral region, between C7 (Channel 1) and T4 (Channel 2). (SANTOS et al., 2013)

DEVICE

TENS and IES Placebo

Same protocol without electrical output.

Trial Locations (1)

5596200190

Luis Ulisses Signori, Santa Maria

All Listed Sponsors
lead

Universidade Federal de Santa Maria

OTHER

NCT03258489 - Effects of TENS and IES on the Autonomous Balance of Normotens Volunteers and Hypertensive Patients | Biotech Hunter | Biotech Hunter