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

Not Applicable

Completed

• Conditions: Venous Thrombosis
• Interventions: Device: Neuromuscular electrical stimulator; Device: AV Impulse System Model 6000

• Registration Number: NCT01894997
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2014-01
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-02
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DVT Prophylaxis	Neuromuscular electrical stimulator	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.
DVT Prophylaxis	AV Impulse System Model 6000	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.

Primary Outcome Measures

Name	Time	Method
Blood flow measurements from the lower limb	Two hours (plus or minus half an hour)	Doppler measurements will be taken for each of the interventions.The measurement site of interest is the popliteal vein, located at the back of the knee. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow will be recorded. 3 measurements of each will be taken per intervention. No measurements will be taken within the first minute of the intervention.

Secondary Outcome Measures

Name	Time	Method
Heart rate	Two hours (plus or minus half an hour)	Heart rate will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.
Blood pressure	Two hours (plus or minus half an hour)	Blood pressure will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.

Trial Locations

Locations (1)

National University of Ireland, Galway; 🇮🇪 Galway, Ireland