Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation L… (NCT01936155) | Clinical Trial Compass
UnknownNot Applicable
Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
Ireland30 participantsStarted 2015-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oedema Reduction
Timeframe: Approximately three and a half hours
Trial details
NCT IDNCT01936155
SponsorNational University of Ireland, Galway, Ireland