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

Venous Thrombosis Clinical Trial

Official title:

A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894997
• Other study ID #: EE-NMES-DVT-334
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: September 2, 2014
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Neuromuscular electrical stimulator

• AV Impulse System Model 6000

Locations

Country	Name	City	State
Ireland	National University of Ireland, Galway	Galway

Sponsors (3)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Galway Clinic, Irish Research Council

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow measurements from the lower limb	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.	Two hours (plus or minus half an hour)	Yes
Secondary	Blood pressure	Blood pressure will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.	Two hours (plus or minus half an hour)	Yes
Secondary	Heart rate	Heart rate will be measured throughout the study using an OMRON RX3 Plus digital automatic blood pressure monitor.	Two hours (plus or minus half an hour)	Yes