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RecruitingNAINTERVENTIONAL

Comparing Injection Treatments for Tennis Elbow

This study is looking into the best ways to treat tennis elbow, a common issue causing pain around the elbow, usually from overuse. Many treatments exist, but we don't yet know which one is the most effective, or the 'gold standard'. This research aims to compare how well different injection treatments work when combined with physiotherapy. Patients will get either an injection of a special gel (called sodium hyaluronate with mannitol), an injection made from their own blood (Platelet-Rich Plasma), or a control injection (a needle inserted but no medicine given), alongside a physiotherapy plan. Researchers will track their pain and arm function over 12 months to see which approach works best.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Wrightington, Wigan and Leigh NHS Foundation Trust
Enrolment target
123
Start
18 Apr 2018
Estimated completion
06 Feb 2026

What is this study about?

Tennis elbow is a common problem that causes pain on the outside of your elbow. It usually happens when you overuse the muscles that straighten your wrist and fingers, often from activities like sports or certain jobs. While there are many ways to treat tennis elbow, such as tablets, physiotherapy, or injections, doctors are still trying to find the very best treatment. Physiotherapy is often recommended and can be very helpful in the long run.

This study wants to learn more about different injection treatments when they are used alongside physiotherapy. We know that some injections, like those made from your own blood (Platelet-Rich Plasma) or a special gel (Hyaluronic Acid), might be better than corticosteroid injections for long-term pain relief. However, we need more research to clearly show which injection is most effective for different people.

To find out, this research will involve people with tennis elbow who will all receive a structured physiotherapy programme. In addition to this, they will be randomly given one of three types of injections: a special gel, a solution made from their own blood, or a 'dummy' injection where only a needle goes into the skin but no medicine is given. The study will then carefully track everyone's pain and how well they can use their arm over 12 months to see which treatment plan works best for improving their symptoms.

Key takeaways

  • This study compares three types of injections for tennis elbow alongside physiotherapy.
  • The aim is to find the most effective treatment for long-term pain relief and better arm function.
  • Participants will be randomly assigned to receive one type of injection (special gel, blood component, or dummy).
  • All participants will also receive a structured physiotherapy program.
  • The study will track progress over 12 months.
  • Your decision to join or leave the study won't affect your regular medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have been diagnosed with tennis elbow, and your symptoms should have lasted for more than three months. Your consultant needs to think that an injection around the tendon is a suitable treatment for you, and you must be able to understand the study and agree to take part.

There are some reasons why you might not be able to join. For example, if you don't feel pain when your elbow is touched in the specific area, or if you've had certain other injections (like steroid, PRP, or hyaluronic acid) in that elbow in the last three months. You also can't take part if you're allergic to any of the injection substances, if you have an infection near the elbow, or if other arm problems might confuse your pain.

Pregnant or breastfeeding women cannot participate. If your pain score is very low (less than 4 out of 10) or if you've recently started medication for anxiety or depression (in the last 6 weeks), you wouldn't be eligible. Also, if you've been in another research study in the past year, or have certain long-term muscle or nerve conditions, you won't be able to join this one.

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 18 years old or older?
  2. Have you been diagnosed with tennis elbow, and have your symptoms lasted over 3 months?
  3. Has your doctor suggested an injection might help your tennis elbow?
  4. Have you avoided steroid, PRP, or hyaluronic acid injections in the affected elbow in the last 3 months?
  5. Are you not pregnant or breastfeeding?
  6. Do you feel pain at your lateral epicondyle (the bony bump on the outside of your elbow)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first meet with a consultant who will explain the study and give you information to read. Later, a research team member will discuss it further, and if you want to proceed, you'll sign a consent form.

Before any treatment, you'll fill out a questionnaire detailing your age, gender, weight, height, how long you've had symptoms, your job, hobbies, and any pain medication you're using. You'll also complete some forms about your pain and how your elbow affects your daily activities.

After this, you'll be randomly assigned to one of three groups. Each group will receive a series of physiotherapy classes. In addition to the physiotherapy, one group will receive an injection of Platelet-Rich Plasma, another will receive an injection of sodium hyaluronate with mannitol, and the third group will receive a sham injection (where a needle is inserted into the skin, but no active substance is injected). You won't know which injection you're receiving. You'll then have follow-up assessments at 3 months and 12 months after your treatment to check your pain and arm function.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a structured physiotherapy program and one of the active injection treatments that could help reduce your tennis elbow pain and improve your arm’s function. However, there's also a chance you might receive the sham injection, which won't provide a medicinal benefit. As with any injection, there are small risks like pain, bruising, or infection at the injection site, though these are rare. You might also experience temporary discomfort from the physiotherapy. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Wrightington Wigan and Leigh NHS Foundation Trust
    Verified postcode
    Wigan, United Kingdom· Recruiting

Common questions

What is 'tennis elbow'?

Tennis elbow is pain on the outside of your elbow, often caused by overuse of the muscles that straighten your wrist.

What is Platelet-Rich Plasma (PRP) injection?

PRP involves taking a small sample of your blood, processing it to concentrate healing cells, and then injecting it back into your elbow.

What is 'sodium hyaluronate with mannitol' injection?

This is an injection containing a special gel that might help with tendon healing and reduce pain.

What is a 'sham injection'?

A sham injection means a needle is gently put into your skin near the elbow, but no actual medication is injected. It helps compare the effects of the active injections.

How long will I be involved in the study?

You'll be followed up for 12 months after your treatment to see how well you're doing.

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 "Comparing Injection Treatments for Tennis Elbow…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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