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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936155
Enrollment
30
Registered
2013-09-05
Start date
2015-08-31
Completion date
2016-07-31
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oedema

Keywords

Joint Mobility, Skin Tissue Oxygenation, Neuromuscular Electrical Stimulation, Goniometry, Transcutaneous Oxygen Measurements (tcpO2), Water Displacement

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.

Interventions

DEVICECustom-built, two-channel stimulator

Custom-built, two-channel stimulator for stimulation of the soleus calf muscle

Sponsors

Merlin Park University Hospital, Galway, Ireland
CollaboratorUNKNOWN
National University of Ireland, Galway, Ireland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oedema ReductionApproximately three and a half hoursOedema 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

MeasureTime frameDescription
Joint MobilityApproximately three and a half hoursA 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 OxygenationApproximately three and a half hoursTranscutaneous 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.

Countries

Ireland

Contacts

Primary ContactDavid Watterson, BSc Podiatry
david.watterson@hse.ie91731480
Backup ContactLeo Quinlan, PhD
leo.quinlan@nuigalway.ie91493710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026