Active not recruitingNAINTERVENTIONAL

Electrical Stimulation for Spasticity in Spinal Cord Injury

This study is investigating whether a type of electrical stimulation called TENS, when applied to the lower back, can help reduce muscle stiffness, known as spasticity, in people who have had a spinal cord injury. Spasticity can make daily tasks difficult, so finding new ways to manage it is important. Researchers want to see if this treatment has immediate effects and if these benefits last over two months. Some participants will receive TENS right away, while others will wait two months before starting. The study will measure how much spasticity improves and how it affects muscle control. The aim is to understand how this electrical stimulation works and if it could offer a safe, non-drug option for managing spasticity.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

04 May 2022

Estimated completion

31 Dec 2026

Spinal Cord Injuries

What is this study about?

This research study is looking into a treatment called Transcutaneous Electrical Nerve Stimulation, or TENS for short. TENS uses small electrical pulses through sticky pads placed on the skin. You might have heard of TENS being used for pain relief. Here, we're exploring if TENS, specifically when applied to the lower back area, can help reduce muscle stiffness and spasms, known as spasticity, in people living with a spinal cord injury. Spasticity can make movements difficult and uncomfortable, affecting everyday life for many.

Previous studies have shown that TENS can sometimes reduce spasticity, but usually when placed directly over the affected muscles. This new approach focuses on placing the TENS pads on the lower back, an area called the lumbosacral region. Early observations from a few people have been promising, showing that this method of TENS might reduce leg spasticity, sometimes quite significantly and immediately. The aim is to understand if these initial good results are consistent in a larger group of people and if the benefits can last for a longer period.

The researchers also want to learn how this lower back TENS works inside the body – specifically, how it affects the nerves and signals that control movement in the legs after a spinal cord injury. If successful, this type of TENS could offer a simple, non-drug way for people to manage their spasticity when they need it, potentially improving their comfort and quality of life.

Key takeaways

This study explores TENS for spinal cord injury spasticity.
TENS applied to the lower back is being tested.
It aims to reduce muscle stiffness and improve movement.
Researchers want to see immediate and lasting effects.
This could lead to a new non-drug treatment for spasticity.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, who has experienced a spinal cord injury. Your injury level should be between C5 and T12. This just helps the researchers ensure that everyone taking part has similar types of spinal cord injuries relevant to the study.

There are also some reasons why you might not be able to join. For instance, if you have a very severe head injury, certain uncontrolled health conditions like autonomic dysreflexia (a specific issue that can affect people with spinal cord injuries), or other health problems that would make using TENS unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a spinal cord injury?
Is your spinal cord injury level between C5 and T12?
Do you *not* have a severe head injury?
Do you *not* have uncontrolled autonomic dysreflexia or other specific health issues that would prevent TENS use?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups. One group will start using TENS right away for two months. The other group will wait two months before they start using TENS. Throughout the study, we'll ask you to do some assessments. These will include simple tests to measure your muscle stiffness, like checking how your legs move. We'll also use special equipment to look at how your nerves and muscles are working. The total study period for everyone will be at least two months, but some may have TENS over a longer period.

Potential risks and benefits

Participating in this study might offer a potential benefit of reduced spasticity and better muscle control, which could improve your daily comfort and movement. However, like any treatment, there's no guarantee it will work for everyone, and you might not experience any direct benefits. Potential risks associated with TENS are generally mild, such as skin irritation where the pads are placed. We would explain all possible risks in more detail before you decide to join. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Alberta - 524 HMRC
Verified postcode
Edmonton, Canada

Common questions

What is spasticity?

Spasticity is when your muscles become stiff, tight, or go into spasms, often making movement difficult after a spinal cord injury.

What does TENS stand for?

TENS stands for Transcutaneous Electrical Nerve Stimulation. It's a method that uses gentle electrical currents through pads on the skin.

Will I know if I'm getting TENS right away?

Yes, you will know if you are in the group getting TENS immediately or if you are in the group that waits two months before starting TENS.

Are there any side effects of TENS?

TENS generally has few side effects, but some people might experience mild skin irritation where the pads are placed. We will explain this in more detail.

How long will the study last for me?

The study period involving TENS application and assessments will last for at least two months for each participant.