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

Intermittent Pneumatic Compression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939288
• Other study ID #: JROHH0324
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Pneumatic Compression

Intervention

Device:
• Neuromuscular stimulation, followed by intermittent pneumatic compression

• Intermittent pneumatic compression, followed by neuromuscular stimulation

Locations

Country	Name	City	State
United Kingdom	Academic Vascular Surgery, Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NMES(on) Peak Velocity Change From Baseline		One day
Primary	IPC(on) Peak Velocity Change From Baseline	Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery	One day

External Links

•   PI information