Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty

NCT ID: NCT01785251

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Deep Vein Thrombosis Total Hip Arthroplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Irish Research Council

OTHER

Sponsor Role collaborator

Mid Western Regional Hospital, Ireland

OTHER

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Gearoid O Laighin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GearĂ³id Ă“Laighin, BEng, MEng, PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

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Mid-Western Regional Orthoapedic Hospital Croom

Limerick, , Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type DERIVED
PMID: 23497524 (View on PubMed)

Other Identifiers

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EE-NMES-DVT-011

Identifier Type: -

Identifier Source: org_study_id

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