A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Blood Flow

N

National University of Ireland, Galway, Ireland

Status

Completed

Conditions

Venous Thrombosis

Treatments

Device: Duo-STIM neuromuscular electrical stimulator
Device: AV Impulse System Model 6000

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT01886612
EE-NMES-DVT-333

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.

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. Both IPC and 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 lower limb haemodynamics.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • History of heart/respiratory problems
  • Pregnancy
  • Presence of implants, including cardiac pacemakers or orthopaedic implants
  • History of a 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)

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 (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 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 1 second duration over a period of 5 minutes.
Treatment:
Device: AV Impulse System Model 6000
Device: Duo-STIM neuromuscular electrical stimulator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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