Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01785251|
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
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:
- To establish if patients in the early post-operative period have tolerance for NMES.
- 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|
|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|
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.
- 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.
- 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.
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
|Mid-Western Regional Orthoapedic Hospital Croom|
|Principal Investigator:||Gearóid ÓLaighin, BEng, MEng, PhD||National University of Ireland Galway|