Intermittent Electrical Stimulation for Pressure Sores

Recruiting at 2 trial locations

Overseen By Fabio Rodriguez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Unstable fractures, Rhabdomyolysis, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

1100 Participants Needed

Trial Summary

What is the purpose of this trial?

Multicentered randomized controlled study with adaptive design to evaluate if Intermittent Electrical Stimulation (IES) decreases progression and facilitates healing of pressure injuries for patients with, sacral / ischial pressure injuries.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Intermittent Electrical Stimulation (IES) for pressure sores?

A feasibility study found that Intermittent Electrical Stimulation (IES) was safe and easy to use in an intensive care setting, with no pressure sores developing in participants during the study. This suggests that IES could potentially help prevent bedsores, although more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is intermittent electrical stimulation safe for humans?

Research on transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) suggests they are generally safe for managing pain in humans, as they have been used in various studies without significant safety concerns. ^{2 3 5 6 7}

How does the treatment Intermittent Electrical Stimulation (IES) for pressure sores differ from other treatments?

Intermittent Electrical Stimulation (IES) is unique because it uses electrical currents to stimulate muscle contractions, which helps redistribute pressure and prevent pressure sores, especially in immobile patients. Unlike conventional methods that rely on pressure relief through repositioning, IES actively engages muscles to reduce pressure on vulnerable areas, making it a novel approach for preventing deep tissue injuries. ^{1 4 8 9 10}

Research Team

Chase Donaldson, MD

Principal Investigator

The Cleveland Clinic

Andrea Kurz, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for patients with new or existing stage 1 or 2 pressure ulcers near the tailbone or hip area, in both ICU and non-ICU settings. Participants must be able to consent, or have someone who can consent for them. It's not for those with certain fractures, muscle breakdown (rhabdomyolysis), heart device implants like pacemakers, skin issues that prevent electrode use on the buttocks, or a BMI over 40.

Inclusion Criteria

I have a new or existing mild to moderate pressure sore on my lower back or buttocks.

I can give my own consent or have someone who can consent for me.

Exclusion Criteria

I have unstable fractures in my spine, pelvis, or hip.

I have a permanent pacemaker or AICD, or I might need an external pacemaker.

I have had rhabdomyolysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the IES device in addition to the standard of care or the standard of care alone. Treatment continues from randomization to discharge, death, or a minimum of 30 days.

30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection continuing for up to 30 days in non-ICU environments or longer if in ICU.

4 weeks

Treatment Details

Interventions

• Intermittent Electrical Stimulation (IES)

Trial Overview The PROTECT 2 Study tests if using an Intermittent Electrical Stimulation (IES) system along with regular turning every two hours helps heal pressure injuries better than just turning patients every two hours. This study randomly assigns participants to either treatment group across multiple centers.

Participant Groups

Group I: Intermittent electrical stimulation system (IES) treatment Group Active Control 1 Intervention

Charged pulses will be administered to bilateral gluteus maximus through surface electrodes. Stimulation occurs at 30 Hz for 10 seconds every 10 minutes.

Group II: Standard of care Group Active Control 1 Intervention

Standard inpatient nursing practice for wound care, wound care prevention, and any other wound care or plastic surgery treatments deemed appropriate as per usual care.

Intermittent Electrical Stimulation (IES) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Approved in European Union as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Approved in Canada as Electrical Stimulation Therapy for:

• Pressure injuries
• Diabetic foot ulcers
• Wound healing

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

Intermittent electrical stimulation (IES) was found to be safe and feasible for preventing pressure ulcers in a study involving 20 immobile patients aged 19 to 86, with no pressure ulcers developing during the study period.

Nurses reported that IES was easy to use and could be integrated into routine care, taking only a few minutes to apply and remove, indicating its practicality in an intensive care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Intermittent Electrical Stimulation to Prevent Deep Tissue Injury in the Intensive Care Unit. Kane, A., Warwaruk-Rogers, R., Ho, C., et al.[2019]

In a study involving 203 patients with knee osteoarthritis, all treatment groups (TENS, IFCs, SWD) showed significant improvements in pain and function, but there were no major differences in effectiveness among the active treatments compared to sham interventions.

Patients receiving active treatments had a significantly lower intake of paracetamol compared to those in sham groups, indicating that physical therapy modalities may enhance pain relief beyond exercise and education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. Atamaz, FC., Durmaz, B., Baydar, M., et al.[2013]

In a study involving 280 individuals with chronic low back pain, both transcutaneous nerve stimulation (TENS) and interferential current (IFC) showed immediate pain relief, with IFC at 4 kHz and 100 Hz being particularly effective.

All treatment groups significantly reduced pain intensity compared to placebo, indicating that both TENS and IFC can be effective non-invasive options for managing chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial. Dias, LV., Cordeiro, MA., Schmidt de Sales, R., et al.[2021]

An educational program significantly improved healthcare providers' knowledge about using electrical stimulation (E-Stim) for treating pressure injuries, with knowledge scores increasing from 55.9% to 78.4% after the online modules and remaining at 78.0% after the hands-on workshop.

While knowledge increased, hands-on workshops were essential for positively changing attitudes towards E-Stim use, indicating that practical experience is crucial for effective implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quasi-Experimental Evaluation of an Education Program for the Use of Electrical Stimulation Therapy to Heal Pressure Injuries. Orr, L., Houghton, P., Holyoke, P., et al.[2021]

In a study involving 30 healthy volunteers, interferential currents (IFC) were found to significantly reduce pain intensity compared to sham electrotherapy, indicating its potential effectiveness for pain management.

However, there was no significant difference in pain relief between IFC and transcutaneous electrical nerve stimulation (TENS), suggesting that both methods may offer similar analgesic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the analgesic effects of interferential currents and transcutaneous electrical nerve stimulation on experimentally induced ischemic pain in otherwise pain-free volunteers. Johnson, MI., Tabasam, G.[2022]

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced exercise-induced pain (EIP) by 12% during isometric contractions and improved time to exhaustion by 38% in a study involving 40 healthy participants.

TENS also enhanced performance in a 16.1 km cycling time trial, resulting in a ~2% faster completion time, indicating that reducing pain can lead to better endurance performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation reduces exercise-induced perceived pain and improves endurance exercise performance. Astokorki, AHY., Mauger, AR.[2021]

Electrical muscle stimulation (EMS) effectively reduces pressure under the ischial tuberosity, which is crucial for preventing pressure sores, as shown in tests with three able-bodied subjects.

The study indicates that EMS can redistribute pressure on seating surfaces without causing fatigue in able-bodied individuals, suggesting its potential for safe, long-term use in pressure sore prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation for pressure variation at the seating interface. Levine, SP., Kett, RL., Cederna, PS., et al.[2006]

Functional electrical stimulation (FES) applied to the quadriceps in seated spinal cord injured (SCI) subjects significantly reduced ischial pressures, with average drops of 44 mmHg on the right and 27 mmHg on the left buttock.

The effectiveness of FES in reducing pressure sores was more pronounced in subjects with larger knee moments, suggesting that FES could be a valuable preventive tool for managing pressure sores in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of seating pressure using FES in patients with spinal cord injury. A preliminary report. Ferguson, AC., Keating, JF., Delargy, MA., et al.[2006]

Intermittent electrical stimulation (IES) was tested in a study involving rats to prevent deep tissue injury (DTI) caused by pressure ulcers, showing that all IES treatment paradigms significantly reduced muscle damage compared to conventional pressure relief methods.

Conventional pressure relief, similar to a wheelchair push-up every 10 minutes, was found to be inadequate for preventing DTI, highlighting the potential of IES as a more effective intervention for preventing deep pressure ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of intermittent electrical stimulation on the prevention of deep tissue injury: varying loads and stimulation paradigms. Curtis, CA., Chong, SL., Kornelsen, I., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Intermittent Electrical Stimulation to Prevent Deep Tissue Injury in the Intensive Care Unit. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of transcutaneous electrical nerve stimulation, interferential currents, and shortwave diathermy in knee osteoarthritis: a double-blind, randomized, controlled, multicenter study. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Immediate analgesic effect of transcutaneous electrical nerve stimulation (TENS) and interferential current (IFC) on chronic low back pain: Randomised placebo-controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A Quasi-Experimental Evaluation of an Education Program for the Use of Electrical Stimulation Therapy to Heal Pressure Injuries. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An investigation into the analgesic effects of interferential currents and transcutaneous electrical nerve stimulation on experimentally induced ischemic pain in otherwise pain-free volunteers. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation reduces exercise-induced perceived pain and improves endurance exercise performance. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation for pressure variation at the seating interface. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Reduction of seating pressure using FES in patients with spinal cord injury. A preliminary report. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

The effects of intermittent electrical stimulation on the prevention of deep tissue injury: varying loads and stimulation paradigms. [2011]