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

NCT ID: NCT01886612

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-08-31

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.

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.

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.

Conditions

Venous Thrombosis

Keywords

Deep Vein Thrombosis; Neuromuscular Electrical Stimulation; Intermittent Pneumatic Compression; Doppler Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DVT Prophylaxis

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.

Group Type: EXPERIMENTAL

Duo-STIM neuromuscular electrical stimulator

Intervention Type: DEVICE

AV Impulse System Model 6000

Intervention Type: DEVICE

Interventions

Duo-STIM neuromuscular electrical stimulator

Intervention Type: DEVICE

AV Impulse System Model 6000

Intervention Type: DEVICE

Other Intervention Names

Intermittent Pneumatic Compression Device

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Irish Research Council

OTHER

Sponsor Role: collaborator

Galway Clinic

NETWORK

Sponsor Role: collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Gearoid O Laighin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gearoid OLaighin, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

National University of Ireland, Galway

Galway, , Ireland

Countries

Ireland

Other Identifiers

EE-NMES-DVT-333

Identifier Type: -

Identifier Source: org_study_id