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

Oedema research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Oedema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Oedema, Joint Mobility, Skin OxygenationNeuromuscular 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.

Study Status

Unknown status

Start Date: August 2015

Completed Date: July 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Oedema Reduction

Secondary Outcome: Joint Mobility

Study sponsors, principal investigator, and references

Principal Investigator: David Watterson, BSc Podiatry

Lead Sponsor: National University of Ireland, Galway, Ireland

Collaborator: Merlin Park University Hospital, Galway, Ireland

More information:https://clinicaltrials.gov/show/NCT01936155

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