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OpenTrials
Completed

NCT Number: NCT01785251

Neuromuscular Electrical Stimulation Following 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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Total Hip Arthroplasty Vascular Diseases Venous Thrombosis

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid-Western Regional Orthoapedic Hospital Croom

Limerick, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Electrical Stimulation

Device

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.

Primary outcomes

  1. Lower limb haemodynamic performance

    Time frame: 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 outcomes

  1. Patient comfort during application of NMES

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National University of Ireland, Galway, Ireland

Other

Collaborators

  • Irish Research Council
  • Mid Western Regional Hospital, Ireland

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2013
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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