OedemaNCT01936155
Does NMES Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
A study testing Custom-built, two-channel stimulator in people with Oedema, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oedema
- What is being tested?
- Custom-built, two-channel stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Merlin Park University Hospital
Galway
David Watterson, BSc Podiatry, 91731480 ext. 00353, david.watterson@hse.ie
David Watterson, BSc Podiatry
About this study
Official title: Does Neuromuscular Electrical Stimulation (NMES) Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
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.
Read more
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.
Read the 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.
- Conditions
- Oedema
- Being tested
- Custom-built, two-channel stimulator
- Keywords
- Joint Mobility, Skin Tissue Oxygenation, Neuromuscular Electrical Stimulation, Goniometry, Transcutaneous Oxygen Measurements (tcpO2), Water Displacement
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-built, two-channel stimulatorDevice
Custom-built, two-channel stimulator for stimulation of the soleus calf muscle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Custom-built, two-channel stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately three and a half hours
Secondary outcomes (2)
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.
Measured: Approximately three and a half hours
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.
Measured: Approximately three and a half hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Merlin Park University Hospital
- Responsible party
- Principal investigator, Gearoid O Laighin, National University of Ireland, Galway, Ireland
- Investigators
- David Watterson, BSc Podiatry, Principal investigator, Merlin Park University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936155
- Sponsor's protocol ID
- EE-NMES-OED-336
- Status last verified
- Apr 2015
- First submitted
- 2 Sep 2013
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Neuromuscular Electrical Stimulation (NMES) Help Relieve Lower Limb Oedema and Improve Joint Mobility and Skin Tissue Oxygenation Levels?
- ClinicalTrials.gov ID
- NCT01936155
- Acronym / sponsor ID
- EE-NMES-OED-336
- Conditions
- Oedema
- Keywords
- Joint Mobility, Skin Tissue Oxygenation, Neuromuscular Electrical Stimulation, Goniometry, Transcutaneous Oxygen Measurements (tcpO2), Water Displacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Merlin Park University Hospital
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oedema, Joint Mobility, Skin Oxygenation | Experimental | Device: Custom-built, two-channel stimulatorNeuromuscular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Skin ulceration in area of intended electrical stimulation site.
- Psychiatric disorder.
- Severe co-morbidity.
- Patients with uncontrolled heart problems.
- Patients with pacemakers, DBS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-built, two-channel stimulatorCustom-built, two-channel stimulator for stimulation of the soleus calf muscle | Device | Oedema, Joint Mobility, Skin Oxygenation |
Primary outcome
Oedema Reduction
Time frame: Approximately three and a half hours
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.
2 secondary outcomes
Joint Mobility
Time frame: Approximately three and a half hours
Skin Oxygenation
Time frame: Approximately three and a half hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Watterson, BSc Podiatry principal investigator
Merlin Park University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-built, two-channel stimulator in people with Oedema, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Watterson, BSc Podiatry (91731480 ext. 00353, david.watterson@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oedema Reduction (time frame: Approximately three and a half hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.