Electro-Neuro-Muscular Stimulation in ICU

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02011282
Study type	Interventional
Source	University of Thessaly
Contact
Status	Completed
Phase	N/A
Start date	October 2013
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03195868` - Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy	N/A
Not yet recruiting	`NCT05565469` - Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location	N/A
Completed	`NCT02309164` - The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).	N/A
Completed	`NCT00775645` - S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, Stage II, or Stage IIIA Breast Cancer Undergoing Chemotherapy	Phase 3
Completed	`NCT03624426` - Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery	N/A
Withdrawn	`NCT03436680` - Home-Based Neurofeedback Program in Treating Participants With Chemotherapy-Induced Peripheral Neuropathy	N/A
Completed	`NCT05691738` - Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy	N/A
Completed	`NCT05095870` - Evaluation of the Peripheral Nerve Ultrasound as a Diagnostic Tool in CANVAS Neuropathies
Completed	`NCT02615678` - Acupuncture for CIPN in Breast Cancer Patients	N/A
Recruiting	`NCT01774058` - The Arterial Measurement of the Blood Flow Volume After Iloprost Stimulation	Phase 2
Completed	`NCT01135251` - Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy	Phase 2
Recruiting	`NCT06324344` - Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)	N/A
Recruiting	`NCT04403802` - Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy	N/A
Recruiting	`NCT04579406` - Perioperative Adverse Cardiovascular Event in Type-2 Diabetic Patients
Recruiting	`NCT03881930` - Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy	N/A
Completed	`NCT03909464` - Non-Invasive Neurosensory Testing For Chemotherapy-Induced Peripheral Neuropathy
Completed	`NCT01523132` - Persistent Pain After Breast Cancer Treatment (PPBCT) - Risk Factors and Pathophysiological Mechanisms	N/A
Completed	`NCT02689661` - Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
Terminated	`NCT00998738` - Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer	Phase 3
Withdrawn	`NCT00528593` - Epoetin Alfa for HIV-Associated Neuropathy Trial	Phase 2