<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/NCT01668953</url>
  </required_header>
  <id_info>
    <org_study_id>IMPROVE-001</org_study_id>
    <secondary_id>Research Seed Grant # 1204</secondary_id>
    <nct_id>NCT01668953</nct_id>
    <nct_alias>NCT01789632</nct_alias>
  </id_info>
  <brief_title>Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arthrex, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Physicians' Services Incorporated Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Radiological Society of North America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Tennis elbow&quot; is the most common cause of lateral elbow pain, generally caused by either&#xD;
      work or sports related repetitive strain. In this condition, a tendon along the outside of&#xD;
      the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.&#xD;
&#xD;
      Many treatments have been attempted, including physiotherapy and steroids, with little&#xD;
      success. One treatment which has been very effective is the injection of the patients own&#xD;
      blood (taken from their other non-affected arm) into their abnormal tendon. The blood&#xD;
      recruits the patients own healing factors and heals the damaged tendon. As platelets are&#xD;
      thought to be largely responsible, injection of concentrated platelets, extracted from the&#xD;
      patient's blood (platelet rich plasma) is a newer, but expensive, technique.&#xD;
&#xD;
      At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a&#xD;
      ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing&#xD;
      (tendon fenestration) is the better treatment.&#xD;
&#xD;
      The objective of this trial is to compare platelet rich plasma, whole blood, dry needle&#xD;
      tendon fenestration, and sham injection (with physical therapy) to identify the best and most&#xD;
      cost-effective therapy for this debilitating condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Did not analyze data&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2023</completion_date>
  <primary_completion_date type="Actual">April 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Reduction</measure>
    <time_frame>Baseline, 6 weeks, 3, 6, 12 months</time_frame>
    <description>Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Disability</measure>
    <time_frame>Baseline, 6 weeks, 3, 6, 12, 24 months</time_frame>
    <description>Functional disability will be measured using the Liverpool Elbow Score (LES) which is an assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Impairment</measure>
    <time_frame>Baseline, 6 weeks, 3, 6, 12, 24 months</time_frame>
    <description>Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Baseline, 6 weeks, 3, 6, 12, 24 months</time_frame>
    <description>Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Lateral Epicondylitis (Tennis Elbow)</condition>
  <arm_group>
    <arm_group_label>Platelet Rich Plasma (PRP) Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole Blood Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry Needle Fenestration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Platelet Rich Plasma (PRP) Injection</intervention_name>
    <description>The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.&#xD;
A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.&#xD;
For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used.&#xD;
Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.&#xD;
The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.</description>
    <arm_group_label>Platelet Rich Plasma (PRP) Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Whole Blood Injection</intervention_name>
    <description>The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.&#xD;
A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.&#xD;
6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.&#xD;
Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.&#xD;
The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.</description>
    <arm_group_label>Whole Blood Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needle Fenestration</intervention_name>
    <description>The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.&#xD;
3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.&#xD;
A 22-gauge needle will then be placed into the tendon.&#xD;
15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon.</description>
    <arm_group_label>Dry Needle Fenestration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Injection</intervention_name>
    <description>The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.&#xD;
3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.&#xD;
The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.</description>
    <arm_group_label>Sham Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult man or woman aged 18 years or greater.&#xD;
&#xD;
          -  Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with&#xD;
             active extension of the wrist in pronation and elbow extension.&#xD;
&#xD;
          -  Documented sonographic diagnosis of common extensor tendinosis based on tendon&#xD;
             thickening, areas of hypoechogenicity, and loss of the normal echotexture.&#xD;
&#xD;
          -  Chronic symptoms (equal or greater than 3 months).&#xD;
&#xD;
          -  Pain of at least 5 out of 10 on a visual analog scale (VAS).&#xD;
&#xD;
          -  Provision of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute symptom onset (less than 2 months).&#xD;
&#xD;
          -  History of acute elbow trauma (less than one week).&#xD;
&#xD;
          -  History of rheumatoid arthritis.&#xD;
&#xD;
          -  History of malignancy.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients requiring anti-platelet medication for the treatment of heart attack, stroke&#xD;
             or other medical condition.&#xD;
&#xD;
          -  Previous surgery for lateral epicondylitis.&#xD;
&#xD;
          -  Previous local injections, including steroids within the past 6 months.&#xD;
&#xD;
          -  Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment,&#xD;
             osteochondral lesion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary M Chiavaras, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lateral Epicondylitis</keyword>
  <keyword>Tennis Elbow</keyword>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>Whole Blood</keyword>
  <keyword>Tendon Fenestration</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>


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/NCT01668953
org study id: IMPROVE-001
secondary id: Research Seed Grant # 1204
nct id: NCT01668953
nct alias: NCT01789632
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either
      work or sports related repetitive strain. In this condition, a tendon along the outside of
      the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.

      Many treatments have been attempted, including physiotherapy and steroids, with little
      success. One treatment which has been very effective is the injection of the patients own
      blood (taken from their other non-affected arm) into their abnormal tendon. The blood
      recruits the patients own healing factors and heals the damaged tendon. As platelets are
      thought to be largely responsible, injection of concentrated platelets, extracted from the
      patient's blood (platelet rich plasma) is a newer, but expensive, technique.

      At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a
      ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing
      (tendon fenestration) is the better treatment.

      The objective of this trial is to compare platelet rich plasma, whole blood, dry needle
      tendon fenestration, and sham injection (with physical therapy) to identify the best and most
      cost-effective therapy for this debilitating condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain Reduction
time frame: Baseline, 6 weeks, 3, 6, 12 months
description: Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).
measure: Functional Disability
time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
description: Functional disability will be measured using the Liverpool Elbow Score (LES) which is an assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.
measure: Psychological Impairment
time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
description: Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression.
measure: Health-Related Quality of Life
time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
description: Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).
arm group label: Platelet Rich Plasma (PRP) Injection
arm group type: Experimental
description: Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
arm group label: Whole Blood Injection
arm group type: Active Comparator
description: Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
arm group label: Dry Needle Fenestration
arm group type: Active Comparator
description: Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
arm group label: Sham Injection
arm group type: Placebo Comparator
description: Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
intervention type: Other
intervention name: Platelet Rich Plasma (PRP) Injection
description: The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used.
Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.
The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
arm group label: Platelet Rich Plasma (PRP) Injection
intervention type: Other
intervention name: Whole Blood Injection
description: The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.
Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.
The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
arm group label: Whole Blood Injection
intervention type: Other
intervention name: Dry Needle Fenestration
description: The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
A 22-gauge needle will then be placed into the tendon.
15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon.
arm group label: Dry Needle Fenestration
intervention type: Other
intervention name: Sham Injection
description: The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.
3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.
arm group label: Sham Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary M Chiavaras, MD, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Tennis Elbow