Can a simple injection cure tennis elbow? new study aims to find out.
NCT ID NCT06040203
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting platelet-rich plasma (PRP) into the elbow can reduce pain and improve function in people with tennis elbow that hasn't gotten better with other treatments. 240 adults will receive either PRP with white blood cells, PRP without white blood cells, or a saltwater placebo injection. The goal is to see which approach works best for easing symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients with epicondylitis of the elbow: 1. Patients with clinical picture of epicondylitis; 2. Duration of symptoms \> 3 months 3. Ultrasound picture of short or long radial extensor carpal tendinopathy; 4. Age \> 18 and \< 65 5. Both sexes; 6. Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months; 7. Hemoglobin \> 11 g/dl; 8. Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination); 9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab 10. No clinically significant electrocardiographic changes (Recently performed ECG); 11. Ability and consent of the patient to actively participate in clinical follow-up; 12. Signature of informed consent. Exclusion Criteria: 1. Patients undergoing previous surgical treatment on the epicondylar tendons; 2. Patients undergoing epicondylar infiltration in the previous 6 months; 3. Inability of patients to actively participate in clinical follow-up; 4. Incapacitated patients; 5. Patients with states of immunodepression; 6. Patients with fibromyalgia; 7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications); 8. Patients with uncontrolled thyroid metabolic disorders; 9. Patients abusing alcoholic beverages, drugs or medications; 10. Patients who have taken NSAIDs in the 3 days prior to blood collection; 11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw; 12. Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated; 13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab 14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Istituto Ortopedico Rizzoli
RECRUITINGBologna, 40136, Italy
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Other studies related to the condition(s) this trial covers.
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- Botox for tennis elbow? new study tests pain relief
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