xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040203</url>
    </required_header>
    <id_info>
      <org_study_id>Epic-PRP</org_study_id>
      <nct_id>NCT06040203</nct_id>
    </id_info>
    <brief_title>Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis</brief_title>
    <official_title>Leukocyte-rich PRP or Leukocyte-free PRP vs Placebo in the Treatment of Epicondylitis: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istituto Ortopedico Rizzoli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istituto Ortopedico Rizzoli</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1&#xD;
        allocation.The objective of the study is to evaluate by means of a randomized controlled,&#xD;
        double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or&#xD;
        without leukocytes compared with echo-guided injection of saline for minimally invasive&#xD;
        treatment of patients with epicondylitis resistant to conservative therapy. It will be the&#xD;
        aim of the study to evaluate the efficacy and safety of the injection procedures by revealing&#xD;
        the improvement and incidence of adverse events following treatment&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with elbow epicondylitis will be included in a double-blind, randomized controlled&#xD;
        trial, in which one group of patients will be treated with an echo-guided injection of LP-PRP&#xD;
        (low leukocyte PRP), one group of patients will be treated with an echo-guided injection of&#xD;
        LR-PRP (high leukocyte PRP), and another group of patients will be treated with an&#xD;
        echo-guided injection of saline.All enrolled patients undergo sampling of a venous whole&#xD;
        blood bag of approximately 300 cc from which Fresh Autologous PRP (PRP-A) will subsequently&#xD;
        be obtained. According to randomization, a &quot;leukodepletion&quot; filter will be used to remove&#xD;
        leukocytes in order to obtain LP-PRP. Instead, an aliquot of PRP will be cryopreserved and&#xD;
        made available for the patient for a possible second PRP infiltration if there is no benefit&#xD;
        after 6 months after the first infiltration.The patient will then be placed on the&#xD;
        randomization list and will, therefore, be assigned to one of the three treatment groups&#xD;
        (leukocyte-rich PRP, leukocyte-poor PRP, or saline solution). In the case of patients in the&#xD;
        saline injection group, PRP will be prepared with or without leukocytes according to a&#xD;
        dedicated randomization list, for possible treatment after 6 months if necessary.The patient&#xD;
        will subsequently undergo 1 echo-guided infiltration, according to randomization.Patients&#xD;
        will be clinically evaluated before the infiltration procedure and at 1-3-6-12 months after&#xD;
        treatment by medical personnel. Questionnaires will be administered for clinical evaluations&#xD;
        before treatment and at the above-mentioned clinical checkups during follow-up. Any adverse&#xD;
        events to treatment will also be evaluated during follow-up visits. The duration and extent&#xD;
        of swelling and pain following infiltration will be reported, and any drug therapies given by&#xD;
        the patient will be recorded&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 23, 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">March 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>This is a double-blind randomized controlled clinical trial with 1:1:1 allocation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>They will be &quot;blinded&quot; patients, health professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patient-rated Tennis Elbow Evaluation (PRTEE)</measure>
      <time_frame>6 months follow-up</time_frame>
      <description>PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as &quot;tennis elbow&quot;). 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).&#xD;
  The total score is the sum of the two subscales and has a range from 0 to 100.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient-rated Tennis Elbow Evaluation (PRTEE)</measure>
      <time_frame>baseline, 1 month, 3 months and 12 months follow-up</time_frame>
      <description>PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as &quot;tennis elbow&quot;). 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).&#xD;
  The total score is the sum of the two subscales and has a range from 0 to 100.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disability of the arm, shoulder and hand score (DASH)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 months and 12 months follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tegner Activity Level Scale</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxford Elbow Score (OES)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>OES 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to &quot;no pain&quot; (0) and &quot;the strongest pain imaginable&quot; (10).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol Visual Analogue Scale (EQ-VAS)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D (EuroQoL) Current Health Assessment</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>EQ-5D is useful to evaluate the quality life of the patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain detect</measure>
      <time_frame>baseline</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Acceptable Symptom State (PASS)</measure>
      <time_frame>baseline, 1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>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 &quot;yes&quot; or &quot;no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Final treatment opinion</measure>
      <time_frame>1 month, 3 months, 6 and 12 months follow-up</time_frame>
      <description>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; &quot;Full recovery&quot;, &quot;much better&quot;, &quot;somewhat better&quot;, &quot;no change&quot;, &quot;a little worse&quot;, &quot;much worse&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness of the blinding procedure</measure>
      <time_frame>baseline</time_frame>
      <description>The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expectations of treatment efficacy</measure>
      <time_frame>baseline</time_frame>
      <description>The patient should indicate at baseline what benefits they expect from the treatment</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Tennis Elbow</condition>
    <arm_group>
      <arm_group_label>Leukocyte-rich Platelet rich plasma (LR-PRP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Leukocyte-poor Platelet rich plasma (LP-PRP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Saline solution</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)</intervention_name>
      <description>Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.</description>
      <arm_group_label>Leukocyte-rich Platelet rich plasma (LR-PRP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)</intervention_name>
      <description>Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.</description>
      <arm_group_label>Leukocyte-poor Platelet rich plasma (LP-PRP)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo (saline solution)</intervention_name>
      <description>Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.</description>
      <arm_group_label>Saline solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with epicondylitis of the elbow:&#xD;
  &#xD;
            1. Patients with clinical picture of epicondylitis;&#xD;
  &#xD;
            2. Duration of symptoms &gt; 3 months&#xD;
  &#xD;
            3. Ultrasound picture of short or long radial extensor carpal tendinopathy;&#xD;
  &#xD;
            4. Age &gt; 18 and &lt; 65&#xD;
  &#xD;
            5. Both sexes;&#xD;
  &#xD;
            6. Failure, defined as persistence of symptoms, of other conservative treatments for at&#xD;
               least 3 months;&#xD;
  &#xD;
            7. Hemoglobin &gt; 11 g/dl;&#xD;
  &#xD;
            8. Platelet count &gt; 150,000 plt/mm3 (Recently performed CBC examination);&#xD;
  &#xD;
            9. Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab&#xD;
  &#xD;
           10. No clinically significant electrocardiographic changes (Recently performed ECG);&#xD;
  &#xD;
           11. Ability and consent of the patient to actively participate in clinical follow-up;&#xD;
  &#xD;
           12. Signature of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients undergoing previous surgical treatment on the epicondylar tendons;&#xD;
  &#xD;
            2. Patients undergoing epicondylar infiltration in the previous 6 months;&#xD;
  &#xD;
            3. Inability of patients to actively participate in clinical follow-up;&#xD;
  &#xD;
            4. Incapacitated patients;&#xD;
  &#xD;
            5. Patients with states of immunodepression;&#xD;
  &#xD;
            6. Patients with fibromyalgia;&#xD;
  &#xD;
            7. Ongoing systemic inflammatory diseases (stabilized outcomes of such diseases are not&#xD;
               considered absolute contraindications);&#xD;
  &#xD;
            8. Patients with uncontrolled thyroid metabolic disorders;&#xD;
  &#xD;
            9. Patients abusing alcoholic beverages, drugs or medications;&#xD;
  &#xD;
           10. Patients who have taken NSAIDs in the 3 days prior to blood collection;&#xD;
  &#xD;
           11. Patients with coagulation problems or with ongoing antiplatelet therapy that cannot be&#xD;
               suspended for at least 3 days prior to blood draw;&#xD;
  &#xD;
           12. Patients with cardiovascular disease for whom a 300-mL blood draw would be&#xD;
               contraindicated;&#xD;
  &#xD;
           13. Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab&#xD;
  &#xD;
           14. Other current elbow diseases (osteoarthritis, prevalence of symptomatology due to&#xD;
               epitrochleitis, stiff elbow, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Enrico Guerra, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Enrico Guerra, MD</last_name>
      <phone>0516366567</phone>
      <email>enrico.guerra@ior.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Roberta Licciardi, MSc</last_name>
      <phone>6366567</phone>
      <phone_ext>051</phone_ext>
      <email>roberta.licciardi@ior.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istituto Ortopedico Rizzoli</name>
        <address>
          <city>Bologna</city>
          <zip>40136</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Enrico Guerra, MD</last_name>
        <phone>6366567</phone>
        <email>enrico.guerra@ior.it</email>
      </contact>
      <contact_backup>
        <last_name>Roberta Licciardi, MSc</last_name>
        <phone>6366567</phone>
        <phone_ext>051</phone_ext>
        <email>roberta.licciardi@ior.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>33330224</PMID>
    </reference>
    <reference>
      <citation>Chen 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.</citation>
      <PMID>19836974</PMID>
    </reference>
    <reference>
      <citation>Hsu 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.</citation>
      <PMID>24292930</PMID>
    </reference>
    <reference>
      <citation>Chen 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.</citation>
      <PMID>29268037</PMID>
    </reference>
    <reference>
      <citation>Karaduman 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.</citation>
      <PMID>26955228</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Platelet rich plasma</keyword>
    <keyword>Leukocyte-rich PRP</keyword>
    <keyword>Leukocyte-poor PRP</keyword>
    <keyword>PRP</keyword>
    <keyword>PRP injection</keyword>
    <keyword>Double-blind randomized controlled clinical trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tennis Elbow</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040203
  org study id: Epic-PRP
  nct id: NCT06040203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: They will be "blinded" patients, health professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
  measure: Patient-rated Tennis Elbow Evaluation (PRTEE)
  time frame: 6 months follow-up
  description: 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.
  measure: Patient-rated Tennis Elbow Evaluation (PRTEE)
  time frame: baseline, 1 month, 3 months and 12 months follow-up
  description: 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.
  measure: Disability of the arm, shoulder and hand score (DASH)
  time frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
  description: 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.
  measure: Tegner Activity Level Scale
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: 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.
  measure: Oxford Elbow Score (OES)
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: OES 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.
  measure: Visual Analogue Scale (VAS)
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: 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).
  measure: EuroQol Visual Analogue Scale (EQ-VAS)
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: 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).
  measure: EQ-5D (EuroQoL) Current Health Assessment
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: EQ-5D is useful to evaluate the quality life of the patients
  measure: Pain detect
  time frame: baseline
  description: 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).
  measure: Patient Acceptable Symptom State (PASS)
  time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
  description: 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.
  measure: Final treatment opinion
  time frame: 1 month, 3 months, 6 and 12 months follow-up
  description: 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".
  measure: Effectiveness of the blinding procedure
  time frame: baseline
  description: The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.
  measure: Expectations of treatment efficacy
  time frame: baseline
  description: The patient should indicate at baseline what benefits they expect from the treatment
  arm group label: Leukocyte-rich Platelet rich plasma (LR-PRP)
  arm group type: Experimental
  description: 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.
  arm group label: Leukocyte-poor Platelet rich plasma (LP-PRP)
  arm group type: Experimental
  description: 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.
  arm group label: Saline solution
  arm group type: Placebo Comparator
  description: 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.
  intervention type: Biological
  intervention name: Injection of autologous leukocyte rich platelet rich plasma (LR-PRP)
  description: Patients will be treated with a single eco-guided injection of Autologous LR-PRP in the elbow affected by epicondylitis.
  arm group label: Leukocyte-rich Platelet rich plasma (LR-PRP)
  intervention type: Biological
  intervention name: Injection of autologous leukocyte poor platelet rich plasma (LP-PRP)
  description: Patients will be treated with a single eco-guided injection of Autologous LP-PRP in the elbow affected by epicondylitis.
  arm group label: Leukocyte-poor Platelet rich plasma (LP-PRP)
  intervention type: Drug
  intervention name: Placebo (saline solution)
  description: Patients will be treated with a single injections of saline solution in the elbow affected by epicondylitis.
  arm group label: Saline solution
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Enrico Guerra, MD
  role: Principal Investigator
  affiliation: Istituto Ortopedico Rizzoli - SC Chirurgia della spalla e del gomito
  last name: Enrico Guerra, MD
  phone: 0516366567
  email: enrico.guerra@ior.it
  last name: Roberta Licciardi, MSc
  phone: 6366567
  phone ext: 051
  email: roberta.licciardi@ior.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  citation: 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.
  PMID: 33330224
  citation: Chen 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.
  PMID: 19836974
  citation: Hsu 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.
  PMID: 24292930
  citation: Chen 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.
  PMID: 29268037
  citation: Karaduman 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.
  PMID: 26955228
  responsible party type: Sponsor
  mesh term: Tennis Elbow