Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

Imperial College London

Status: Completed

Conditions: Intermittent Pneumatic Compression

Treatments: Device: Neuromuscular stimulation, followed by intermittent pneumatic compression; Device: Intermittent pneumatic compression, followed by neuromuscular stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01939288

JROHH0324

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2

Exclusion Criteria

History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group 1

Experimental group

Description:

Half of recruited subjects (n=5)

Treatment:

Device: Neuromuscular stimulation, followed by intermittent pneumatic compression

Group 2

Experimental group

Description:

Other half of recruited subjects (n=5)

Treatment:

Device: Intermittent pneumatic compression, followed by neuromuscular stimulation