Transcutaneous Electrical Nerve Stimulation on Nervous System in Patients With Hypertension.
NCT ID: NCT02292199
Last Updated: 2014-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-08-31
2015-08-31
Brief Summary
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Cardiovascular disease is the leading cause of death and disability in the world and autonomic imbalance is associated with several pathological conditions, and may be a final common pathway for the increased morbidity and mortality of cardiovascular diseases. In this sense, the heart rate variability (HRV) is a quantitative marker of sympathetic and parasympathetic activity, which can be used to assess disease and mortality as a noninvasive technique.
TENS is a noninvasive therapeutic modality, easy to handle, it has no side effects or interactions with medications being used for the relief of pain by sensory stimulation through peripheral nerves and mainly for control and treatment of acute and chronic pain . Research on the effect of TENS on the sympathetic and parasympathetic nervous system activity remain controversial, especially regarding the parameters to use.
The aim of this study is to investigate the effects of TENS on the sympathetic and parasympathetic nervous system in patients with hypertension by heart rate variability and blood pressure variability.
This is a randomized clinical trial, double blind, where hypertensive patients were randomized to three groups: high-frequency TENS (100 Hz) n = 20, low frequency TENS (4 Hz) n = 20 and n = 20 placebo. Evaluations will be made in a single session. The results will be assessed by a blinded investigator and randomization will be done electronically.
It is expected to evaluate how often TENS exerts more influence in the modulation of sympathetic and parasympathetic system.
Detailed Description
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Patients were randomized to group of high frequency (100 Hz / 200μs), low frequency (4 Hz / 200μs) or placebo. The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010). Eligible subjects were randomly assigned in blocks, by electronic randomization (www.randomization.com).
The adhesive electrodes were used, size 9x5 cm, placed in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. Before the application of TENS (IBRAMED®), the skin was cleaned in place of the current application with alcohol to avoid any barrier conduction of electrical current.
The sessions took place at the same time of the day, throughout the protocol, the participants were comfortably accommodated in an acclimatized room (23ºC) in a supine position, head elevation of 30º with knees resting on a wedge. All the participants were forbidden to perform exhaustive exercises and intake caffeine at least two hours before the intervention and instructed to have a meal before the assessment.
TENS was applied for thirty minutes, with the frequency defined according to randomization. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
The analysis of autonomic control was performed by means of a sensor placed on the middle finger, and connected to the Finapres (Ohmeda 2300, Colorado, USA) by recording beat to beat. Then, the conversion signal was performed using the powerlab (LAB chart). The analysis will be performed using the software Kubios.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TENS High Frequency 100 Hz
TENS was applied for thirty minutes, with the frequency defined according to randomization. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS High Frequency
TENS high frequency (100 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS Low Frequency 4 Hz
TENS was applied for thirty minutes, with the frequency defined according to randomization. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS Low Frequency
TENS low frequency (4 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS Placebo
The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010).
TENS Placebo
TENS was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010).
Interventions
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TENS High Frequency
TENS high frequency (100 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS Low Frequency
TENS low frequency (4 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
TENS Placebo
TENS was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Instituto de Cardiologia do Rio Grande do Sul
OTHER
Federal University of Health Science of Porto Alegre
OTHER
Responsible Party
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Rodrigo Della Méa Plentz
Effects of transcutaneous electrical nerve stimulation on sympathetic and parasympathetic nervous system in patients with hypertension: a randomized clinical trial
Principal Investigators
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Rodrigo DM Plentz, Phd
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Locations
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Rodrigo Della Méa Plentz
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYPERTENSIONTENS
Identifier Type: -
Identifier Source: org_study_id