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

NCT01936155 | Unknown

• 1 other identifier: EE-NMES-OED-336
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oedema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately three and a half hours

Secondary Outcomes (2)

• Joint Mobility

  Approximately three and a half hours

• Skin Oxygenation

  Approximately three and a half hours

Study Arms (1)

Oedema, Joint Mobility, Skin Oxygenation

EXPERIMENTAL

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

Interventions

Custom-built, two-channel stimulator DEVICE

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

Oedema, Joint Mobility, Skin Oxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Merlin Park University Hospital, Galway, Ireland: collaborator

Study Sites (1)

Merlin Park University Hospital

Galway, Ireland

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Watterson, BSc Podiatry

  Merlin Park University Hospital, Galway, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Watterson, BSc Podiatry

CONTACT

91731480; david.watterson@hse.ie

Leo Quinlan, PhD

CONTACT

91493710; leo.quinlan@nuigalway.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

IE (1)