Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis
ConditionTennis Elbow
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Ortopedico Rizzoli
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)
Biological/VaccinePatients 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/VaccinePatients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.
Placebo (saline solution)
DrugPatients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Leukocyte-rich Platelet rich plasma (LR-PRP)Experimental treatment 1 intervention
Group B: Leukocyte-poor Platelet rich plasma (LP-PRP)Experimental treatment 1 intervention
Group C: Saline solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months follow-upSecondary outcomes
1
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.
Time frame
baseline, 1 month, 3 months and 12 months follow-up2
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.
Time frame
baseline, 1 month, 3 months, 6 months and 12 months follow-up3
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.
Time frame
baseline, 1 month, 3 months, 6 and 12 months follow-up4
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
Time frame
baseline, 1 month, 3 months, 6 and 12 months follow-upSponsors and contacts
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Source ClinicalTrials.gov