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

Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886612
• Other study ID #: EE-NMES-DVT-333
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: August 1, 2013
• Start date: June 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Duo-STIM 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 must be taken for each of the interventions. The measurement site of interest is the popliteal vein, located at the lateral aspect of the knee, below the sapheno-popliteal junction. Peak venous velocity, time averaged mean velocity, vein cross-sectional area and volume flow are required. A minimum of 3 measurements per intervention is required for rigor. Do not take any measurement within the first minute of the intervention	An hour and a half (plus or minus half an hour)	Yes
Secondary	Blood Pressure		An hour and a half (plus or minus half an hour)	Yes
Secondary	Heart Rate		An hour and a half (plus or minus half an hour)	Yes