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

Primary Purpose

Oedema

Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Custom-built, two-channel stimulator
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oedema focused on measuring Joint Mobility, Skin Tissue Oxygenation, Neuromuscular Electrical Stimulation, Goniometry, Transcutaneous Oxygen Measurements (tcpO2), Water Displacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Merlin Park University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oedema, Joint Mobility, Skin Oxygenation

Arm Description

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.

Outcomes

Primary Outcome Measures

Oedema Reduction
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.

Secondary Outcome Measures

Joint Mobility
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.
Skin Oxygenation
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.

Full Information

First Posted
September 2, 2013
Last Updated
April 14, 2015
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Merlin Park University Hospital, Galway, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01936155
Brief Title
Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
Official Title
Does Neuromuscular Electrical Stimulation (NMES) Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Merlin Park University Hospital, Galway, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oedema
Keywords
Joint Mobility, Skin Tissue Oxygenation, Neuromuscular Electrical Stimulation, Goniometry, Transcutaneous Oxygen Measurements (tcpO2), Water Displacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oedema, Joint Mobility, Skin Oxygenation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Custom-built, two-channel stimulator
Intervention Description
Custom-built, two-channel stimulator for stimulation of the soleus calf muscle
Primary Outcome Measure Information:
Title
Oedema Reduction
Description
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.
Time Frame
Approximately three and a half hours
Secondary Outcome Measure Information:
Title
Joint Mobility
Description
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.
Time Frame
Approximately three and a half hours
Title
Skin Oxygenation
Description
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.
Time Frame
Approximately three and a half hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Watterson, BSc Podiatry
Phone
91731480
Ext
00353
Email
david.watterson@hse.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Leo Quinlan, PhD
Phone
91493710
Ext
00353
Email
leo.quinlan@nuigalway.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Watterson, BSc Podiatry
Organizational Affiliation
Merlin Park University Hospital, Galway, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merlin Park University Hospital
City
Galway
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Watterson, BSc Podiatry
Phone
91731480
Ext
00353
Email
david.watterson@hse.ie
First Name & Middle Initial & Last Name & Degree
David Watterson, BSc Podiatry
First Name & Middle Initial & Last Name & Degree
Leo Quinlan, PhD
First Name & Middle Initial & Last Name & Degree
Gearoid Ó Laighin, PhD
First Name & Middle Initial & Last Name & Degree
Barry Broderick, PhD
First Name & Middle Initial & Last Name & Degree
Sandra O'Connell, BSc

12. IPD Sharing Statement

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

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