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

Oedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01936155
• Other study ID #: EE-NMES-OED-336
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2013
• Last updated: April 14, 2015
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2015
• Source: National University of Ireland, Galway, Ireland
• Contact: David Watterson, BSc Podiatry
• Phone: 91731480
• Email: david.watterson[@]hse.ie
• Is FDA regulated: No
• Health authority: Ireland: Health Service Executive
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Oedema

Intervention

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

Locations

Country	Name	City	State
Ireland	Merlin Park University Hospital	Galway

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Merlin Park University Hospital, Galway, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	Approximately three and a half hours	Yes
Secondary	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.	Approximately three and a half hours	Yes