Neuromuscular Electrical Stimulation Versus Intermittent Pneumatic Compression for Blood Flow

Venous Thrombosis Clinical Trial

Official title:

Improved Lower Limb Haemodynamics Using Neuromuscular Electrical Stimulation (NMES); Potential Novel DVT Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862471
• Other study ID #: EE-NMES-DVT-012
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: June 19, 2013
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: June 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 However, few studies have directly compared the two methods and those that have, have used outdated NMES devices.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.

Recruitment information / eligibility

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

Eligibility

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

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

Related Conditions & MeSH terms

• Thrombosis
• Venous Thrombosis

Intervention

Device:
• Neuromuscular Electrical Stimulation
Frequency of 36Hz, 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.
• Intermittent Pneumatic Compression
Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	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		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