Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow

Not Applicable

Completed

• Conditions: Venous Thrombosis
• Interventions: Device: Neuromuscular Electrical Stimulation; Device: Intermittent Pneumatic Compression

• Registration Number: NCT01862471
• 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 However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.

The objective of this study is to compare the effectiveness of a modern NMES device to intermittent pneumatic compression in terms of blood flow.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

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

Inclusion Criteria

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
• Under 18 years of age or over 40 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DVT prophylaxis	Neuromuscular Electrical Stimulation	Neuromuscular electrical stimulation 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 was applied every 20 seconds over a period of 5 minutes. Intermittent pneumatic compression 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.
DVT prophylaxis	Intermittent Pneumatic Compression	Neuromuscular electrical stimulation 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 was applied every 20 seconds over a period of 5 minutes. Intermittent pneumatic compression 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.

Primary Outcome Measures

Name	Time	Method
Blood Flow Measurements from the Lower Limb	An hour and a half (plus or minus half an hour)

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	An hour and a half (plus or minus half an hour)
Heart Rate	An hour and a half (plus or minus half an hour)

Trial Locations

Locations (1)

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