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Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT01785251
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborators:
Irish Research Council
Mid Western Regional Hospital, Ireland
Information provided by (Responsible Party):
Gearoid O Laighin, 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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Total Hip Arthroplasty Device: Neuromuscular Electrical Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery From Total Hip Arthroplasty
Study Start Date : June 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785251


Locations
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Ireland
Mid-Western Regional Orthoapedic Hospital Croom
Limerick, Ireland
Sponsors and Collaborators
National University of Ireland, Galway, Ireland
Irish Research Council
Mid Western Regional Hospital, Ireland
Investigators
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Principal Investigator: Gearóid ÓLaighin, BEng, MEng, PhD National University of Ireland Galway

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gearoid O Laighin, Professor, National University of Ireland, Galway, Ireland
ClinicalTrials.gov Identifier: NCT01785251     History of Changes
Other Study ID Numbers: EE-NMES-DVT-011
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by Gearoid O Laighin, National University of Ireland, Galway, Ireland:
Neuromuscular electrical stimulation
NMES
Deep vein thrombosis
DVT
total hip arthroplasty
lower limb hemodynamics
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases