Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty

Deep Vein Thrombosis Clinical Trial

Official title:

Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery From Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785251
• Other study ID #: EE-NMES-DVT-011
• Status: Completed
• Phase: N/A
• First received: February 1, 2013
• Last updated: February 4, 2013
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 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

Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein Thrombosis (DVT) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. The use of calf muscle neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established.

The main objectives are:

1. To establish if patients in the early post-operative period have tolerance for NMES.

2. To determine if applying NMES to patients immediately post-THA increases venous outflow from the lower limb over resting conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who underwent total hip arthroplasty the previous day

Exclusion Criteria:

• Patients with Diabetes Mellitus

• Patients with Peripheral Vascular Disease

• Patients currently involved in another trial

• Previous diagnosis of DVT

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Total Hip Arthroplasty
• Venous Thrombosis

Intervention

Device:
• Neuromuscular Electrical Stimulation
Applied using a custom built, medically approved stimulator called the Duo-STIM. NMES to be applied to the calf muscles to elicit a muscular contraction to eject blood through the venous system.

Locations

Country	Name	City	State
Ireland	Mid-Western Regional Orthoapedic Hospital Croom	Limerick

Sponsors (3)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Irish Research Council, Mid Western Regional Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb haemodynamic performance	Duplex Doppler ultrasound will be used as the outcome measure. Both legs will be measured for hemodynamic performance in the popliteal vein by placing the probe at the popliteal fossa.; Measurements of peak venous velocity (cm/s), popliteal vein diameter (cm), time averaged mean velocity (TAMEAN, cm/s) and volume flow (ml/min) will be recorded.; Doppler measurements will be taken initially at rest, before the application of NMES and once again when the NMES session had commenced.	4 hours	No
Secondary	Patient comfort during application of NMES	Measurements will be taken at 3 time points (before application of NMES, after application of NMES had begun and at the end of the protocol).; The measurement consists of asking patients to mark their level of comfort using a 100mm, non-hatched visual-analogue-scale (VAS).; A VAS of 30 mm or less will be categorised as mild pain, between 31 and 69mm as moderate pain and scores of 70mm or greater as severe pain.	4 hours	No