Clinical trial NCT01936155: Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
Official title: Does Neuromuscular Electrical Stimulation (NMES) Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oedema
Keywords: Joint Mobility
Skin Tissue Oxygenation
Neuromuscular Electrical Stimulation
Goniometry
Transcutaneous Oxygen Measurements (tcpO2)
Water Displacement
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Merlin Park University Hospital, Galway, Ireland
First posted: 2013-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oedema Reduction
timeFrame: Approximately three and a half hours
Secondary outcomes:
measure: Joint Mobility
timeFrame: Approximately three and a half hours
measure: Skin Oxygenation
timeFrame: Approximately three and a half hours
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Merlin Park University Hospital
Study officials:
affiliation: Merlin Park University Hospital, Galway, Ireland
name: David Watterson, BSc Podiatry
role: PRINCIPAL_INVESTIGATOR
References: