Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-06-30

Brief Summary

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Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.

The objective of this study is to compare the effectiveness of a modern NMES device to intermittent pneumatic compression in terms of blood flow.

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Detailed Description

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Conditions

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Venous Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DVT prophylaxis

Neuromuscular electrical stimulation using a custom-built, two-channel stimulator (Duo-STIM (stimulator), Bioelectronics Research Cluster, National University of Ireland, Galway) with a frequency of 36 Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms. Stimulation was applied every 20 seconds over a period of 5 minutes.

Intermittent pneumatic compression using the Novamedix A-V Impulse System Model 6000 (Novamedix distribution Limited, England), programmed to deliver compression every 20 seconds at a pressure of 130 mmHg for a 1 second duration over a period of 5 minutes.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Frequency of 36Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms.

Intermittent Pneumatic Compression

Intervention Type DEVICE

Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.

Interventions

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Neuromuscular Electrical Stimulation

Frequency of 36Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms.

Intervention Type DEVICE

Intermittent Pneumatic Compression

Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.

Intervention Type DEVICE

Other Intervention Names

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Custom-built, two-channel stimulator (Duo-STIM, Bioelectronics Research Cluster, NUI Galway) Novamedix AV Impulse System Model 6000 (Novamedix distribution Limited, England)

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* History of heart/respiratory problems
* Pregnancy
* Presence of implants, including cardiac pacemakers and orthopaedic implants
* History of neurological disorder
* History of severe arterial disease or known dermatological problems
* Under 18 years of age or over 40 years of age

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes