AuthorisedTherapeutic use (Phase IV)Interventional

Randomized Clinical Trial for the Treatment of Lateral Epicondylitis with Debridement Arthroscopic Versus Cytokine-Rich Autologous Serum. (SARC)

This research study is looking at the treatment for elbow pain, specifically a condition called epicondylitis (which includes ‘tennis elbow’). It's comparing two main approaches: a type of surgery and a newer treatment using a special fluid made from your own blood, called cytokine-rich autologous serum (SARC). The SARC treatment involves two injections into the affected area of your elbow, given about 2 to 3 weeks apart. Researchers want to see if this blood-based treatment is effective and safe. They will be carefully watching for any side effects and how well patients' elbow pain improves compared to those who have the standard surgery. This type of study aims to find out if new treatments are better or just as good as existing ones for people with this condition.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Parc Tauli Hospital Universitari

Enrolment target

Start

20 Nov 2024

Epicondylitis

What is this study about?

This study is about finding better ways to treat a common type of elbow pain, often known as 'tennis elbow' or epicondylitis. This condition can cause a lot of discomfort and make everyday activities difficult. Doctors are looking into two different treatment options.

One treatment involves a type of surgery. The other is a newer approach where doctors use a special liquid prepared from your own blood. This liquid, called cytokine-rich autologous serum, contains helpful substances from your blood that might encourage healing in your elbow. The idea is to inject this special liquid directly into the painful area.

The main goal of this study is to compare these two treatments to see which one works better and has fewer side effects. By carefully observing patients in both treatment groups, the researchers hope to understand more about the most effective and safest ways to help people with elbow pain get back to feeling their best.

Key takeaways

This study compares surgery to a new blood-based injection for elbow pain.
The new SARC treatment uses your own blood and involves 2 injections, 2-3 weeks apart.
The main goal is to find out which treatment works best and is safest.
Participants will have regular check-ups to monitor their progress and any side effects.
Potential risks include infection or swelling; benefits include finding a new effective treatment.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part.

There might be other health conditions or medications that could prevent you from joining. The study team will review your medical history carefully to make sure the study is a safe and suitable option for you.

If you have elbow pain and meet these general criteria, the study doctors will chat with you about all the details to see if this study is a good fit for you.

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.

Am I 18 years old or older?
Do I have elbow pain (epicondylitis, or 'tennis elbow')?
Have I discussed my general health with my doctor?
Am I able to attend regular follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you choose to take part in this study, and you are in the group receiving the special blood treatment (SARC), you will generally have two injections. These injections will be given about 2 to 3 weeks apart. If, for certain medical reasons, the doctor decides you only receive one injection, you will still stay in the study and have all the same check-ups and follow-up appointments as everyone else.

During your time in the study, you will have regular check-ups with the study team. They will monitor your elbow pain, check for any side effects, and make sure you are doing well. The total length of the study for each participant isn't specified here, but it will involve these initial treatments and follow-up visits to track your progress.

Potential risks and benefits

Taking part in this study could potentially help you manage your elbow pain with a new treatment. However, as with any medical procedure, there are potential risks, such as unexpected infections where the injection is given, a fever, or an allergic reaction, though these are uncommon. You might also experience some swelling in the treated area. The study team will closely monitor you for any problems. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is 'tennis elbow'?

'Tennis elbow' is a common term for elbow pain or inflammation, medically called epicondylitis, which can affect people who don't even play tennis.

What is SARC treatment?

SARC is a special liquid made from your own blood, containing substances that might help your elbow heal. It's given as an injection.

How many injections will I get?

If you receive the SARC treatment, you will usually get two injections, about 2-3 weeks apart. Sometimes, only one injection might be given if decided by the doctor.

Will I still be monitored if I only get one injection?

Yes, even if you only receive one injection, you will still have all the same follow-up appointments and checks as other participants.

What are the potential side effects of the treatment?

Possible side effects could include infection, allergic reactions, or swelling at the injection site. The study team will closely watch for these.