All studies
Enrolling by invitationNAINTERVENTIONAL

Comparison of Ultrasound-guided Electrolysis Therapy vs. Sham Electrolysis in Patients With Patellar Tendinopathy: A Prospective Randomized Study Including MRI and Shear-wave Ultrasound Elastography Imaging

This study aims to find out if a new treatment called ultrasound-guided galvanic electrolysis therapy (USGET) can help people with 'jumper's knee' (patellar tendinopathy). This condition causes pain and difficulty moving around. The treatment uses a gentle electrical current with ultrasound to encourage the tendon to heal. Researchers will compare it to a 'sham' (dummy) treatment that looks and feels similar but doesn't deliver the electrical current. Participants in both groups will also do special exercises. The main goal is to see if USGET reduces pain, but the study will also look at how well the knee works, its flexibility, and changes to the tendon using scans. The study hopes to offer a better way to treat this common and often long-lasting problem.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
Gymna Uniphy
Enrolment target
74
Start
29 Oct 2024
Estimated completion
01 Oct 2026

What is this study about?

You've probably heard of 'jumper's knee,' or patellar tendinopathy. It's a common problem, especially for people who play sports or do activities that involve a lot of jumping. It happens when the tendon connecting your kneecap to your shin bone gets inflamed or damaged, causing pain and making it hard to move.

Traditional treatments for jumper's knee can sometimes be tricky because tendons don't have a very good blood supply, which means they can take a long time to heal. This study is looking into a new approach called ultrasound-guided galvanic electrolysis therapy, or USGET. This treatment uses a special device that delivers a tiny electrical current, guided by ultrasound, directly to the affected part of your tendon. The idea is that this electrical current might help promote healing in the tendon. Researchers want to see if this new treatment works better than a 'sham' (dummy) treatment, where you get the same process but without the actual electrical current.

Over 24 months, the study will involve two groups: one receiving the real USGET treatment and the other receiving the sham treatment. Both groups will also do specific exercises designed to strengthen the tendon. The main things researchers will be looking at are whether your pain goes down and how much your knee function improves. They will also use scans like MRI to see if there are any changes to your tendon itself. By comparing these two groups, scientists hope to learn if USGET is a safe and effective way to help people with jumper's knee get back to their daily activities with less pain.

Key takeaways

  • This study explores a new electrical current treatment for jumper's knee.
  • It compares the new treatment to a dummy (sham) treatment.
  • The main aim is to see if the treatment reduces pain and improves knee function.
  • Participants will also do specific exercises as part of the study.
  • The study runs for seven months for each participant.
  • Results will help understand if this new treatment is effective.

Who may be eligible?

To be able to take part in this study, you generally need to be an adult between 18 and 59 years old. You must have been diagnosed with patellar tendinopathy (jumper's knee) and not have any other major bone or joint problems at the same time. You also need to be able to fully understand the study and agree to take part.

There are several reasons why you might not be able to join. For example, if you are under 18 or over 59, or if you are pregnant or breastfeeding, the study won't be suitable for you. You also couldn't take part if you have certain other conditions like fractures, sprains, or arthritis, or if you have an open wound or infection where your knee is. If you've recently had steroid injections or certain other types of injections into your tendon, or if you're taking specific medications like blood thinners or some anti-inflammatory drugs, you might also not be eligible.

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.

  1. Are you between 18 and 59 years old?
  2. Do you have a diagnosis of jumper's knee (patellar tendinopathy)?
  3. Are you able to understand and agree to take part in the study?
  4. Are you currently pregnant or breastfeeding?
  5. Do you have any other serious bone, joint, or muscle conditions in your leg?
  6. Have you recently had steroid injections into your knee tendon?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be involved for about seven months in total. This includes your initial checks, four months of treatment, and a further three months of follow-up. You would be randomly assigned to one of two groups: either receiving the active ultrasound-guided electrolysis treatment or a 'sham' (dummy) version of the treatment. Both groups will also be given specific exercises to do. Researchers will assess your pain levels and how well your knee works at the beginning, after four months, and again after seven months. They will use standard questionnaires for pain and function, and you will also have scans like MRI and ultrasound to look at your knee tendon.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your condition and potentially receive a new treatment that could help reduce your pain and improve your knee function. However, there's always a chance that the treatment might not work for you, or you might be in the 'sham' group and not receive the active treatment. While the electrolysis treatment is generally considered safe, there could be minor side effects, though the study design aims to minimise these. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Paracelsus Sportmedizin & Prävention Bremen
    Verified postcode
    Bremen, Germany

Common questions

What is 'jumper's knee'?

Jumper's knee, or patellar tendinopathy, is pain and inflammation in the tendon that connects your kneecap to your shin bone, often caused by activities like jumping.

What is ultrasound-guided electrolysis?

It's a new treatment that uses a mild electrical current, guided by ultrasound imaging, to encourage healing in a damaged tendon.

Will I know if I'm getting the real treatment or the dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor the study team will know which treatment you are receiving until after the study is over. This helps make the results fair.

How long will the study last if I join?

Your involvement in the study will last for a total of about seven months, including treatment and follow-up checks.

Can I leave the study at any time?

Yes, absolutely. You are free to withdraw from the study at any point without it affecting your current or future medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Comparison of Ultrasound-guided Electrolysis Therapy vs. Sha…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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