RecruitingNAINTERVENTIONAL

Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Cubital tunnel syndrome happens when a nerve in your elbow gets squeezed, causing pain, numbness, and weakness in your hand. For severe cases, even with surgery, people often don't fully recover. This study is testing a new approach: giving a brief electrical stimulation to the affected arm shortly after surgery. Researchers want to see if this electrical treatment, which has shown promise in animal studies, can help nerves regenerate faster and improve hand use. The study compares people who get the electrical stimulation to those who only have surgery, to find out if this simple, one-hour treatment can make a real difference in how well patients recover.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

01 Apr 2022

Estimated completion

28 Jun 2028

Cubital Tunnel Syndrome Electrical Stimulation

What is this study about?

Cubital tunnel syndrome is a condition where one of the main nerves in your arm, called the ulnar nerve, gets squeezed at your elbow. This can cause tingling, numbness, and weakness in your hand, especially in your little finger and ring finger. For some people, the condition can become very severe, making it difficult to use their hand properly. Even after surgery, which is often done to relieve pressure on the nerve, full recovery isn't always achieved.

This is where this study comes in. Researchers are looking for ways to help people heal better and faster, particularly after severe nerve damage. They are investigating a treatment called "electrical stimulation." This involves sending small, gentle electrical pulses to the affected area. Previous studies in animals have suggested that this kind of electrical stimulation can encourage nerves to grow and repair themselves more quickly.

In this study, some patients will receive this brief electrical stimulation shortly after their cubital tunnel surgery, while others will only have the surgery (this is called a "control group"). Neither the patients nor their doctors will know who is getting the electrical stimulation – this is to make sure the results are fair and unbiased. The main goal is to see if adding this relatively simple, one-hour electrical treatment can lead to better hand function and quicker nerve recovery compared to surgery alone. If successful, it could offer a valuable new tool to help people regain more use of their hands.

Key takeaways

This study evaluates electrical stimulation after surgery for severe cubital tunnel syndrome.
It aims to see if nerves heal faster and hand function improves.
The electrical treatment is short, lasting about one hour.
Participation involves either electrical stimulation or surgery alone, with neither you nor your doctor knowing which.
The study seeks to find new ways to help patients recover better from severe nerve damage.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old. The study is specifically for people with severe cubital tunnel syndrome. This means your doctors will have observed clear signs and symptoms of a serious trapped nerve in your elbow.

Your doctors would also have performed special tests to confirm this. These tests include a needle EMG, which checks the electrical activity in your muscles, and another test called MUNE, which measures the number of working nerve fibres. These tests must show significant nerve damage and muscle weakness caused by your cubital tunnel syndrome.

You would not be able to join if you have another nerve injury at the same time, if you've already had surgery for cubital tunnel syndrome before, or if you have other medical problems affecting your nervous system.

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 over 18 years old?
Have you been diagnosed with severe cubital tunnel syndrome?
Do tests show significant nerve and muscle damage in your hand due to this condition?
Have you NOT had previous surgery for cubital tunnel syndrome?
Do you NOT have any other nerve injuries or conditions affecting your nervous system?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo surgery for your cubital tunnel syndrome. Following the surgery, you will either receive a brief electrical stimulation treatment for about one hour, or you will be in the control group. Neither you nor your doctor will know which group you are in. The study will then involve follow-up appointments where doctors will check your progress, nerve function, and how well you can use your hand. The exact number of visits, specific assessments, and the overall length of time you'd be involved aren't detailed here but would be fully explained before you agree to participate.

Potential risks and benefits

Potential benefits of taking part could include improved nerve recovery and better hand function compared to surgery alone if the electrical stimulation treatment is effective. There are usually minimal risks associated with brief electrical stimulation, as it's generally well-tolerated. However, as with any medical procedure, there's always a chance of minor discomfort or skin irritation. You can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is cubital tunnel syndrome?

It's when a major nerve in your elbow gets squeezed, causing numbness, tingling, and weakness in your hand.

What is electrical stimulation?

It's a treatment that uses small electrical pulses to encourage nerves to repair and regrow.

How long does the electrical treatment take?

The electrical stimulation treatment itself only takes about one hour.

Will I know if I'm getting the electrical treatment or not?

No, neither you nor your doctor will know if you're receiving the electrical stimulation or just standard care. This helps ensure fair results.

What happens if I don't want to continue in the study?

You are free to leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Ming Chan

ming.chan@ualberta.ca (780) 492-1614 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.