A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb

National University of Ireland, Galway, Ireland

Status: Completed

Conditions: Venous Thrombosis

Treatments: Device: AV Impulse System Model 6000; Device: Neuromuscular electrical stimulator

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01894997

EE-NMES-DVT-334

Details and patient eligibility

About

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 dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow, in both a young and an older population.

Full description

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) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Free from any known illness
• Between 18 and 40 years of age
• Between 55 and 65 years of age

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

DVT Prophylaxis

Experimental group

Description:

Neuromuscular electrical stimulation is to be applied using a custom-built, two-channel 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 is to be applied every 20 seconds over a period of 5 minutes. Intermittent pneumatic compression is to be applied 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 3 second duration over a period of 5 minutes.

Treatment:

Device: Neuromuscular electrical stimulator

Device: AV Impulse System Model 6000