Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Total Hip Arthroplasty
• Interventions: Device: Neuromuscular Electrical Stimulation

• Registration Number: NCT01785251
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-02
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-04
• Last Update Submitted: 2013-02-04
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NMES	Neuromuscular Electrical Stimulation	Application of neuromuscular electrical stimulation to the calf muscles of the patient in order to elicit contraction of the calf muscle pump and thus, eject venous blood proximally.

Primary Outcome Measures

Name	Time	Method
Lower limb haemodynamic performance	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
Patient comfort during application of NMES	4 hours	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.

Trial Locations

Locations (1)

Mid-Western Regional Orthoapedic Hospital Croom; 🇮🇪 Limerick, Ireland