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Clinical Trials/NCT01936155
NCT01936155
Unknown
Not Applicable

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

National University of Ireland, Galway, Ireland1 site in 1 country30 target enrollmentAugust 2015
ConditionsOedema

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oedema
Sponsor
National University of Ireland, Galway, Ireland
Enrollment
30
Locations
1
Primary Endpoint
Oedema Reduction
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
July 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gearoid O Laighin

Professor

National University of Ireland, Galway, Ireland

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Joint Mobility(Approximately three and a half hours)
  • Skin Oxygenation(Approximately three and a half hours)

Study Sites (1)

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