Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
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|ClinicalTrials.gov Identifier: NCT01939288|
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
What is known?
- Disorders of peripheral circulation result in vascular morbidity and mortality
- Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
- The benefit of intermittent pneumatic compression is clinically well evidenced.
- The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.
What new information will this trial contribute?
- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
|Condition or disease||Intervention/treatment||Phase|
|At Rest Intervention (Intermittent Pneumatic Compression or Neuromuscular Stimulation)||Device: Neuromuscular stimulation, followed by intermittent pneumatic compression Device: Intermittent pneumatic compression, followed by neuromuscular stimulation||Not Applicable|
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.
OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.
METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Group 1
Half of recruited subjects (n=5)
Device: Neuromuscular stimulation, followed by intermittent pneumatic compression
Other Name: Device 1 followed by a break, followed by device 2
Experimental: Group 2
Other half of recruited subjects (n=5)
Device: Intermittent pneumatic compression, followed by neuromuscular stimulation
Other Name: Device 2, followed by a short break then device 2
- IPC(on) Peak Velocity Change From Baseline [ Time Frame: One day ]Composite ultrasound measurements of venous and arterial peak velocity, time averaged maximum velocity, and flow rate. This is taken from the left leg superficial femoral vein and artery
- NMES(on) Peak Velocity Change From Baseline [ Time Frame: One day ]
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): NCT01939288
|Academic Vascular Surgery, Charing Cross Hospital|
|London, United Kingdom, W6 8RF|