MyopathyNCT02011282
Electro-Neuro-Muscular Stimulation in ICU
A study testing Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days in people with Myopathy and Neuropathy, run by University of Thessaly at 1 site in Greece.
Trial summary
We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myopathy, Neuropathy
- What is being tested?
- Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2013to Mar 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged>18 years old and <85 years old, hospitalized in the ICU for at least 96 hours
Who cannot join
- pregnancy, autoimmune disease, pre-existing known neuromuscular diseases, presence of bone fractures on the lower extremities, use of corticoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients
We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect the incidence density rate of nosocomial pneumonia in the ICU.
Patients will be divided into two groups, Group A and Group B chosen at random. In Group A conventional physiotherapy will be applied while in Group B, ENMS will also be applied additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will be 1 hour, it will be applied before the start of the physiotherapy per day of hospitalization and for 10 days in each patient.
Read more
The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori Trichrome will be used to determine the existence or absence of myopathy. In addition the ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3), thus achieving a separation of myopathy and neuropathy.
The primary outcome of the study will be the incidence of myopathy in both groups, at day 12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing this rate by 50% in the intervention group using statistical power equal to 0.80 up to a level of p <0.05, 12 number of patients will be required in each group.
- Conditions
- Myopathy, Neuropathy
- Being tested
- Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days
- Keywords
- ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA
- Medical subject headings
- Muscular Diseases, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 daysOther
| Study group | Role | What they receive |
|---|---|---|
| Electro-Neuro-Muscular Stimulation | Experimental | Patients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days Receives: Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days |
| Control | No intervention | Patients in this arm will receive the usual standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of myopathy
Presence of myopathy in critical care patients; myopathy will be assessed with biopsy of quadriceps at day 12 after entering the study (17 day of ICU hospitalization)
Measured: 12 days
Secondary outcomes (1)
NEUROPATHY
presence of peripheral neuropathy after 12 days of hospitalization in the ICU
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopathyStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DEMOSTHENES MAKRIS, University of Thessaly
- Investigators
- EPAMINONDAS ZAKYNTHINOS, PROF, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011282
- Sponsor's protocol ID
- CIM-TRIAL
- Status last verified
- Aug 2014
- First submitted
- 9 Dec 2013
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electro-Neuro-Muscular Stimulation in Hospitalized Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02011282
- Acronym / sponsor ID
- CIM-TRIAL
- Conditions
- Myopathy, Neuropathy
- Keywords
- ICU,, MYOPATHY,, NEUROPATHY,, PNEUMONIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Dec 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.
We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect the incidence density rate of nosocomial pneumonia in the ICU.
Patients will be divided into two groups, Group A and Group B chosen at random. In Group A conventional physiotherapy will be applied while in Group B, ENMS will also be applied additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will be 1 hour, it will be applied before the start of the physiotherapy per day of hospitalization and for 10 days in each patient.
The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori Trichrome will be used to determine the existence or absence of myopathy. In addition the ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3), thus achieving a separation of myopathy and neuropathy.
The primary outcome of the study will be the incidence of myopathy in both groups, at day 12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing this rate by 50% in the intervention group using statistical power equal to 0.80 up to a level of p <0.05, 12 number of patients will be required in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro-Neuro-Muscular Stimulation | Experimental | Other: Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 daysPatients will receive daily sessions of electrostimulation with a commercially available device (En-Stimulation 4, Netherlands) in the quadriceps muscle for 10 days |
| Control | No intervention | –Patients in this arm will receive the usual standard treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged>18 years old and <85 years old, hospitalized in the ICU for at least 96 hours
Key exclusion criteria (1 listed)
- pregnancy, autoimmune disease, pre-existing known neuromuscular diseases, presence of bone fractures on the lower extremities, use of corticoids
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 |
|---|---|---|
| Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days | Other | Electro-Neuro-Muscular Stimulation |
Primary outcome
incidence of myopathy
Time frame: 12 days
Presence of myopathy in critical care patients; myopathy will be assessed with biopsy of quadriceps at day 12 after entering the study (17 day of ICU hospitalization)
1 secondary outcome
NEUROPATHY
Time frame: 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
EPAMINONDAS ZAKYNTHINOS, PROF study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days in people with Myopathy and Neuropathy, run by University of Thessaly at 1 site in Greece.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of myopathy (time frame: 12 days). 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 30 Mar 2015.