Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Total Hip Arthroplasty
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland
    • Mid-Western Regional Orthoapedic Hospital Croom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NMES; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Irish Research Council; Mid Western Regional Hospital, Ireland
• Investigators: Principal Investigator: Gearóid ÓLaighin, BEng, MEng, PhD, National University of Ireland, Galway

Publications and helpful links

General Publications

• Broderick BJ, Breathnach O, Condon F, Masterson E, Olaighin G. Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty. J Orthop Surg Res. 2013 Mar 5;8:3. doi: 10.1186/1749-799X-8-3.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 4, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: total hip arthroplasty; Deep vein thrombosis; DVT; NMES; Neuromuscular electrical stimulation; lower limb hemodynamics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: EE-NMES-DVT-011