Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
Primary Purpose
Deep Vein Thrombosis, Total Hip Arthroplasty
Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Deep Vein Thrombosis focused on measuring Neuromuscular electrical stimulation, NMES, Deep vein thrombosis, DVT, total hip arthroplasty, lower limb hemodynamics
Eligibility 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
Sites / Locations
- Mid-Western Regional Orthoapedic Hospital Croom
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NMES
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01785251
First Posted
February 1, 2013
Last Updated
February 4, 2013
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Research Council, Mid Western Regional Hospital, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT01785251
Brief Title
Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
Official Title
Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery From Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Research Council, Mid Western Regional Hospital, Ireland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Total Hip Arthroplasty
Keywords
Neuromuscular electrical stimulation, NMES, Deep vein thrombosis, DVT, total hip arthroplasty, lower limb hemodynamics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NMES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
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 Measure Information:
Title
Lower limb haemodynamic performance
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Patient comfort during application of NMES
Description
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.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gearóid ÓLaighin, BEng, MEng, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid-Western Regional Orthoapedic Hospital Croom
City
Limerick
Country
Ireland
12. IPD Sharing Statement
Citations:
PubMed Identifier
23497524
Citation
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.
Results Reference
derived
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Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
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