Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?

April 14, 2015 updated by: Gearoid O Laighin, National University of Ireland, Galway, Ireland

Does Neuromuscular Electrical Stimulation (NMES) Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?

Neuromuscular Electrical Stimulation (NMES) will be facilitated through the use of a stimulator, with the patient in a semi recumbent position, using UltraStim electrodes. Two 5 cm x 5 cm electrodes will be placed over the soleus muscle for calf stimulation. The participant will be allowed to ramp up the stimulus level themselves to get used to the sensation and determine their maximum tolerated stimulus level.

A goniometer will be used to assess mobility at the knee and ankle joints. Transcutaneous oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 500 tcpO2 monitor.

The level of oedema will be measured using the figure of eight measurement, tape circumference measurement and water displacement measurement.

Comfort will also be assessed by use of a 100mm non-hatched visual analogue scale (VAS). Each participant will be asked to indicate their level of comfort following the application of NMES.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Neuromuscular Electrical Stimulation (NMES) will be facilitated through the use of a two-channel, research stimulator, with the patient in a semi recumbent position, using UltraStim electrodes. Two 5 cm x 5 cm electrodes will be placed over the soleus muscle for calf stimulation. The participant will be allowed to ramp up the stimulus level themselves to get used to the sensation and determine their maximum tolerated stimulus level.

A goniometer will be used to assess mobility at the knee and ankle joints. Transcutaneous oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 500 tcpO2 monitor.

The level of oedema will be measured using the figure of eight measurement, tape circumference measurement and water displacement measurement.

Comfort will also be assessed by use of a 100mm non-hatched visual analogue scale (VAS). Each participant will be asked to indicate their level of comfort following the application of NMES. VAS pain scores of 30 mm or less will be categorised as mild pain, between 31 and 69 mm as moderate pain, and scores of 70 mm or greater as severe pain.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • Merlin Park University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients that present to Merlin Park Podiatry Clinic for Podiatric Intervention who on clinical examination present with lower lib swelling/oedema/
  • Ability to understand the nature of the study.
  • Ability to give informed consent.

Exclusion Criteria:

  • Skin ulceration in area of intended electrical stimulation site.
  • Psychiatric disorder.
  • Severe co-morbidity.
  • Patients with uncontrolled heart problems.
  • Patients with pacemakers, DBS.
  • Patients on opioid or neuropathic pain medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oedema, Joint Mobility, Skin Oxygenation
Neuromuscular electrical stimulation (NMES) is to be applied using a custom-built, two-channel stimulator, Bioelectronics Research Cluster, National University of Ireland, Galway) with a frequency of 36 Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms. Stimulation is to be applied every 20 seconds over a period of 90 minutes. Its affect on oedema reduction, joint mobility and skin oxygenation will be assessed both before and after its application.
Device: Custom-built, two-channel stimulator
Custom-built, two-channel stimulator for stimulation of the soleus calf muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oedema Reduction
Time Frame: Approximately three and a half hours
Oedema measurements (figure of eight measurement, tape circumference measurement and water displacement measurement) will be taken before and after the application of neuromuscular electrical stimulation (NMES) in order to assess its affect on the reduction of oedema.
Approximately three and a half hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint Mobility
Time Frame: Approximately three and a half hours
A goniometer will be used to assess mobility at the ankle and knee joints both before and after the application of neuromuscular electrical stimulation (NMES) to the soleus muscle of the calf.
Approximately three and a half hours
Skin Oxygenation
Time Frame: Approximately three and a half hours
Transcutaneous oxygen measurements (tcpO2) will be assessed using the PERIMED Periflux System 5000 tcpO2 monitor both before and after the application of NMES to the soleus muscle in order to assess its affect on skin tissue oxygenation levels.
Approximately three and a half hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Ireland, Galway, Ireland

Collaborators

Merlin Park University Hospital, Galway, Ireland

Investigators

  • Principal Investigator: David Watterson, BSc Podiatry, Merlin Park University Hospital, Galway, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 2, 2013

First Submitted That Met QC Criteria

September 2, 2013

First Posted (Estimate)

September 5, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EE-NMES-OED-336

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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