Tennis ElbowNCT06040203
Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
A study testing Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) and Injection of autologous leukocyte poor platelet rich plasma (LP-PRP) in people with Tennis Elbow, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) and Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteItaly
- Study dates
- 23 Mar 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with epicondylitis of the elbow:
- Patients with clinical picture of epicondylitis;
- Duration of symptoms > 3 months
- Ultrasound picture of short or long radial extensor carpal tendinopathy;
- Age > 18 and < 65
- Both sexes;
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- Failure, defined as persistence of symptoms, of other conservative treatments for at least 3 months;
- Hemoglobin > 11 g/dl;
- Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- No clinically significant electrocardiographic changes (Recently performed ECG);
- Ability and consent of the patient to actively participate in clinical follow-up;
- Signature of informed consent.
Who cannot join
- Patients undergoing previous surgical treatment on the epicondylar tendons;
- Patients undergoing epicondylar infiltration in the previous 6 months;
- Inability of patients to actively participate in clinical follow-up;
- Incapacitated patients;
- Patients with states of immunodepression;
- Patients with fibromyalgia;
Show all 14Show fewer
- Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not considered absolute contraindications);
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Patients who have taken NSAIDs in the 3 days prior to blood collection;
- Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be suspended for at least 3 days prior to blood draw;
- Patients with cardiovascular disease for whom a 300-mL blood draw would be contraindicated;
- Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to epitrochleitis, stiff elbow, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Enrico Guerra, MD, 6366567, enrico.guerra@ior.it
Roberta Licciardi, MSc, 6366567 ext. 051, roberta.licciardi@ior.it
About this study
Official title: Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
Read the detailed description
Patients with elbow epicondylitis will be included in a double-blind, randomized controlled trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP (low leukocyte PRP), one group of patients will be treated with an echo-guided injection of LR-PRP (high leukocyte PRP), and another group of patients will be treated with an echo-guided injection of saline.All enrolled patients undergo sampling of a venous whole blood bag of approximately 300 cc from which Fresh Autologous PRP (PRP-A) will subsequently be obtained. According to randomization, a "leukodepletion" filter will be used to remove leukocytes in order to obtain LP-PRP. Instead, an aliquot of PRP will be cryopreserved and made available for the patient for a possible second PRP infiltration if there is no benefit after 6 months after the first infiltration.The patient will then be placed on the randomization list and will, therefore, be assigned to one of the three treatment groups (leukocyte-rich PRP, leukocyte-poor PRP, or saline solution). In the case of patients in the saline injection group, PRP will be prepared with or without leukocytes according to a dedicated randomization list, for possible treatment after 6 months if necessary.The patient will subsequently undergo 1 echo-guided infiltration, according to randomization.Patients will be clinically evaluated before the infiltration procedure and at 1-3-6-12 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checkups during follow-up. Any adverse events to treatment will also be evaluated during follow-up visits. The duration and extent of swelling and pain following infiltration will be reported, and any drug therapies given by the patient will be recorded
- Conditions
- Tennis Elbow
- Being tested
- Injection of autologous leukocyte rich platelet rich plasma (LR-PRP), Injection of autologous leukocyte poor platelet rich plasma (LP-PRP), Placebo (saline solution)
- Keywords
- Platelet rich plasma, Leukocyte-rich PRP, Leukocyte-poor PRP, PRP, PRP injection, Double-blind randomized controlled clinical trial
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)Biological
Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.
Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)Biological
Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.
Placebo (saline solution)Drug
Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte-rich Platelet rich plasma (LR-PRP) | Experimental | This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received. Receives: Biological: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) |
| Leukocyte-poor Platelet rich plasma (LP-PRP) | Experimental | This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received. Receives: Biological: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP) |
| Saline solution | Placebo comparator | This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list. Receives: Drug: Placebo (saline solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do).
The total score is the sum of the two subscales and has a range from 0 to 100.
Measured: 6 months follow-up
Secondary outcomes (12)
Patient-rated Tennis Elbow Evaluation (PRTEE)
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do).
The total score is the sum of the two subscales and has a range from 0 to 100.
Measured: baseline, 1 month, 3 months and 12 months follow-up
Disability of the arm, shoulder and hand score (DASH)
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Measured: baseline, 1 month, 3 months, 6 months and 12 months follow-up
Tegner Activity Level Scale
Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability and 10 represents a competitive level of sport.
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
Oxford Elbow Score (OES)
Oxford Elbow score is a questionnaire consisting of 12 questions (related to pain, function, and socio-psychological aspects) specifically designed and developed to evaluate the outcomes of elbow surgery.
The Oxford Elbow score has 12 items (questions) with 5 response options each. Each item response is scored as 0 to 4, with 0 representing greater severity. Underlying the 12 items are 3 domains (subscales): elbow pain, elbow function and social-psychological effects. Scores for each domain are calculated as the sum of each individual item score within that domain. This gives a score range of 0-16 for each domain and 0-48 overall, with 0 indicating the worst elbow score and 48 as a 'normal' elbow score
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
Visual Analogue Scale (VAS)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10).
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
EuroQol Visual Analogue Scale (EQ-VAS)
EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
The generic health-related quality of life instrument-EQ-5D-allows both a description of health status along 5 dimensions and the evaluation of health or the estimation of a health summary score: the EQ-5D score on a scale where 0 is death and 1 is full health. EQ-5D is useful to evaluate the quality life of the patients. The EQ-5D respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems).
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
Pain detect
The Pain Detect-Questionnaire is a reliable screening tool for neuropathic pain with high sensitivity, specificity, and positive predictive accuracy. In this scale, the score ranges from 0 to 38 (range 0-12 neuropathic component of pain unlikely, range 13-18 neuropathic component of pain probably present, range 19-38 neuropathic component of pain present).
Measured: baseline
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Measured: baseline, 1 month, 3 months, 6 and 12 months follow-up
Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Measured: 1 month, 3 months, 6 and 12 months follow-up
Effectiveness of the blinding procedure
The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.
Measured: baseline
Expectations of treatment efficacy
The patient should indicate at baseline what benefits they expect from the treatment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start23 Mar 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrico Guerra, MD, Principal investigator, Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040203
- Sponsor's protocol ID
- Epic-PRP
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim GM, Yoo SJ, Choi S, Park YG. Current Trends for Treating Lateral Epicondylitis. Clin Shoulder Elb. 2019 Dec 1;22(4):227-234. doi: 10.5397/cise.2019.22.4.227. eCollection 2019 Dec.
PubMed 33330224Chen J, Wang A, Xu J, Zheng M. In chronic lateral epicondylitis, apoptosis and autophagic cell death occur in the extensor carpi radialis brevis tendon. J Shoulder Elbow Surg. 2010 Apr;19(3):355-62. doi: 10.1016/j.jse.2009.07.064.
PubMed 19836974Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
PubMed 24292930Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21.
PubMed 29268037Karaduman M, Okkaoglu MC, Sesen H, Taskesen A, Ozdemir M, Altay M. Platelet-rich plasma versus open surgical release in chronic tennis elbow: A retrospective comparative study. J Orthop. 2016 Jan 22;13(1):10-4. doi: 10.1016/j.jor.2015.12.005. eCollection 2016 Mar.
PubMed 26955228
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06040203
- Acronym / sponsor ID
- Epic-PRP
- Conditions
- Tennis Elbow
- Keywords
- Platelet rich plasma, Leukocyte-rich PRP, Leukocyte-poor PRP, PRP, PRP injection, Double-blind randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
Detailed description
Patients with elbow epicondylitis will be included in a double-blind, randomized controlled trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP (low leukocyte PRP), one group of patients will be treated with an echo-guided injection of LR-PRP (high leukocyte PRP), and another group of patients will be treated with an echo-guided injection of saline.All enrolled patients undergo sampling of a venous whole blood bag of approximately 300 cc from which Fresh Autologous PRP (PRP-A) will subsequently be obtained. According to randomization, a "leukodepletion" filter will be used to remove leukocytes in order to obtain LP-PRP. Instead, an aliquot of PRP will be cryopreserved and made available for the patient for a possible second PRP infiltration if there is no benefit after 6 months after the first infiltration.The patient will then be placed on the randomization list and will, therefore, be assigned to one of the three treatment groups (leukocyte-rich PRP, leukocyte-poor PRP, or saline solution). In the case of patients in the saline injection group, PRP will be prepared with or without leukocytes according to a dedicated randomization list, for possible treatment after 6 months if necessary.The patient will subsequently undergo 1 echo-guided infiltration, according to randomization.Patients will be clinically evaluated before the infiltration procedure and at 1-3-6-12 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checkups during follow-up. Any adverse events to treatment will also be evaluated during follow-up visits. The duration and extent of swelling and pain following infiltration will be reported, and any drug therapies given by the patient will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-rich Platelet rich plasma (LR-PRP) | Experimental | Biological: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)This group of patients will be treated with single injection of autologous leukocyte rich platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received. |
| Leukocyte-poor Platelet rich plasma (LP-PRP) | Experimental | Biological: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)This group of patients will be treated withsSingle injection of autologous leukocyte poor platelet rich plasma.At the 6-month follow-up visit, the patient will be informed about the treatment received. |
| Saline solution | Placebo comparator | Drug: Placebo (saline solution)This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months following a dedicated randomization list. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with clinical picture of epicondylitis;
- Duration of symptoms > 3 months
- Ultrasound picture of short or long radial extensor carpal tendinopathy;
- Age > 18 and < 65
- Both sexes;
Key exclusion criteria (14 listed)
- Patients undergoing previous surgical treatment on the epicondylar tendons;
- Patients undergoing epicondylar infiltration in the previous 6 months;
- Inability of patients to actively participate in clinical follow-up;
- Incapacitated patients;
- Patients with states of immunodepression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis. | Biological | Leukocyte-rich Platelet rich plasma (LR-PRP) |
| Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis. | Biological | Leukocyte-poor Platelet rich plasma (LP-PRP) |
| Placebo (saline solution)Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis. | Drug | Saline solution |
Primary outcome
Patient-rated Tennis Elbow Evaluation (PRTEE)
Time frame: 6 months follow-up
PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1) Pain subscale (0 = no pain, 10 = worst imaginable) item 2) Function subscale (0 = no difficulty, 10 = unable to do). The total score is the sum of the two subscales and has a range from 0 to 100.
12 secondary outcomes
Patient-rated Tennis Elbow Evaluation (PRTEE)
Time frame: baseline, 1 month, 3 months and 12 months follow-up
Disability of the arm, shoulder and hand score (DASH)
Time frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
Tegner Activity Level Scale
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Oxford Elbow Score (OES)
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Visual Analogue Scale (VAS)
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Pain detect
Time frame: baseline
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Final treatment opinion
Time frame: 1 month, 3 months, 6 and 12 months follow-up
Effectiveness of the blinding procedure
Time frame: baseline
Expectations of treatment efficacy
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 33330224Kim GM, Yoo SJ, Choi S, Park YG. Current Trends for Treating Lateral Epicondylitis. Clin Shoulder Elb. 2019 Dec 1;22(4):227-234. doi: 10.5397/cise.2019.22.4.227. eCollection 2019 Dec.
- Background: PubMed 19836974Chen J, Wang A, Xu J, Zheng M. In chronic lateral epicondylitis, apoptosis and autophagic cell death occur in the extensor carpi radialis brevis tendon. J Shoulder Elbow Surg. 2010 Apr;19(3):355-62. doi: 10.1016/j.jse.2009.07.064.
- Background: PubMed 24292930Hsu WK, Mishra A, Rodeo SR, Fu F, Terry MA, Randelli P, Canale ST, Kelly FB. Platelet-rich plasma in orthopaedic applications: evidence-based recommendations for treatment. J Am Acad Orthop Surg. 2013 Dec;21(12):739-48. doi: 10.5435/JAAOS-21-12-739.
- Background: PubMed 29268037Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21.
- Background: PubMed 26955228Karaduman M, Okkaoglu MC, Sesen H, Taskesen A, Ozdemir M, Altay M. Platelet-rich plasma versus open surgical release in chronic tennis elbow: A retrospective comparative study. J Orthop. 2016 Jan 22;13(1):10-4. doi: 10.1016/j.jor.2015.12.005. eCollection 2016 Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Guerra, MD principal investigator
Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of autologous leukocyte rich platelet rich plasma (LR-PRP) and Injection of autologous leukocyte poor platelet rich plasma (LP-PRP) in people with Tennis Elbow, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico Guerra, MD (0516366567, enrico.guerra@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-rated Tennis Elbow Evaluation (PRTEE) (time frame: 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040203, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.