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

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ClinicalTrials.gov Identifier: NCT01886612
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : August 2, 2013
Sponsor:
Collaborators:
Irish Research Council
Galway Clinic
Information provided by (Responsible Party):
Gearoid O Laighin, National University of Ireland, Galway, Ireland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Venous Thrombosis Device: Duo-STIM neuromuscular electrical stimulator Device: AV Impulse System Model 6000 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression in Terms of Lower Limb Haemodynamics
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Device: Duo-STIM neuromuscular electrical stimulator
Device: AV Impulse System Model 6000
Other Name: Intermittent Pneumatic Compression Device


Outcome Measures
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Primary Outcome Measures :
  1. Blood Flow Measurements from the Lower Limb [ Time Frame: An hour and a half (plus or minus half an hour) ]
    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


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: An hour and a half (plus or minus half an hour) ]
  2. Heart Rate [ Time Frame: An hour and a half (plus or minus half an hour) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886612


Locations
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Ireland
National University of Ireland, Galway
Galway, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Irish Research Council
Galway Clinic
Investigators
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Principal Investigator: Gearoid OLaighin, PhD National University of Ireland Galway
More Information
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Responsible Party: Gearoid O Laighin, Professor, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT01886612    
Other Study ID Numbers: EE-NMES-DVT-333
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Keywords provided by Gearoid O Laighin, National University of Ireland, Galway, Ireland:
Deep Vein Thrombosis
Neuromuscular Electrical Stimulation
Intermittent Pneumatic Compression
Doppler Ultrasound
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases