<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/NCT02246530</url>
  </required_header>
  <id_info>
    <org_study_id>F131231006</org_study_id>
    <nct_id>NCT02246530</nct_id>
  </id_info>
  <brief_title>Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma</brief_title>
  <official_title>Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to identify an effective and conservative approach to treating&#xD;
      partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical&#xD;
      correction needed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based off literature and clinical practice, the majority of rotator cuff tears continue to&#xD;
      progress to surgical correction despite conservative measures. These include physical&#xD;
      therapy, medication management and minimally invasive procedures such as subacromial bursa&#xD;
      injections and intra-articular injections with steroids. Recently a popular treatment of&#xD;
      common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and&#xD;
      has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich&#xD;
      Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB&#xD;
      Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid&#xD;
      injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are&#xD;
      ultrasound imaging, pain and disability over the course of 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated prematurely due to inability to complete recruitment of subjects for each of&#xD;
    the trial groups (treatment and control).&#xD;
  </why_stopped>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">March 2021</completion_date>
  <primary_completion_date type="Actual">January 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Ultrasound</measure>
    <time_frame>6 months post procedure</time_frame>
    <description>Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.&#xD;
Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain and Disability Index</measure>
    <time_frame>Week 3 post procedure SPADI Scores for the control and treatment groups.</time_frame>
    <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain and Disability Index</measure>
    <time_frame>Week 6 post procedure SPADI Scores for the treatment and control groups.</time_frame>
    <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain and Disability Index</measure>
    <time_frame>6 months post procedure SPADI scores for the treatment and control groups.</time_frame>
    <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Partial Tear of Rotator Cuff</condition>
  <condition>Tendinopathy of Rotator Cuff</condition>
  <arm_group>
    <arm_group_label>PRP injection into PTRCT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment - PRP injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subacromial steroid bursal injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRP injection into PTRCT</intervention_name>
    <description>Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
    <arm_group_label>PRP injection into PTRCT</arm_group_label>
    <other_name>Biologics</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Subacromial steroid bursal injection</intervention_name>
    <description>Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
    <arm_group_label>Subacromial steroid bursal injection</arm_group_label>
    <other_name>Procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. subjects between ages 19 to 75, both male and female&#xD;
&#xD;
          2. radiologic imaging which can include either magnetic resonance imaging (MRI) or&#xD;
             ultrasound (US) consistent with partial thickness rotator cuff tears of any degree&#xD;
             except for full thickness tears&#xD;
&#xD;
          3. Failed a trial of physical therapy of at least 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Full thickness tears (well documented need for surgical correction)&#xD;
&#xD;
          2. sensory or neurologic complaint affecting the shoulder of interest&#xD;
&#xD;
          3. Coagulation disorder, platelet disorder&#xD;
&#xD;
          4. Pregnancy: Pregnancy test will be performed on women of childbearing age prior to&#xD;
             their participation in the interventional portion of the study&#xD;
&#xD;
          5. Any major systemic illness such as ongoing infection or any condition that requires&#xD;
             strict anti-platelet or anticoagulation therapy&#xD;
&#xD;
          6. Prior surgery to either cervical spine or shoulder&#xD;
&#xD;
          7. Active military&#xD;
&#xD;
          8. Injury part of worker compensation claim&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Breanna Willeford, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UAB Highlands</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <results_first_submitted>February 7, 2022</results_first_submitted>
  <results_first_submitted_qc>May 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2022</results_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Breanna Willeford</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 4, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT02246530/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from an outpatient Physical Medicine and Rehabilitation clinic at the University of Alabama. Each subject was given information regarding the study requirements and follow up obligations prior to enrollment and signed to complete based on their confidentiality agreement form.</recruitment_details>
      <pre_assignment_details>Three subjects in this study were enrolled however prior to randomization in to their respective groups, they had a negative diagnostic ultrasound thus they were excluded from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PRP Injection Into PTRCT</title>
          <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
        </group>
        <group group_id="P2">
          <title>Subacromial Steroid Bursal Injection</title>
          <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PRP Injection Into PTRCT</title>
          <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
        </group>
        <group group_id="B2">
          <title>Subacromial Steroid Bursal Injection</title>
          <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.13" lower_limit="28" upper_limit="62"/>
                    <measurement group_id="B2" value="57.5" lower_limit="55" upper_limit="60"/>
                    <measurement group_id="B3" value="50" lower_limit="28" upper_limit="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SPADI (Shoulder Pain and Disability Index) Score</title>
          <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores pre-intervention in each group. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score divided by 130). Thus the final score is a range of 0% to 100%.</description>
          <units>SPADI Score</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.69" lower_limit="20.77" upper_limit="62.31"/>
                    <measurement group_id="B2" value="23.08" lower_limit="21.54" upper_limit="24.62"/>
                    <measurement group_id="B3" value="37.80" lower_limit="20.77" upper_limit="62.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diagnostic Ultrasound</title>
        <description>Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.&#xD;
Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.</description>
        <time_frame>6 months post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PRP Injection Into PTRCT</title>
            <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
          </group>
          <group group_id="O2">
            <title>Subacromial Steroid Bursal Injection</title>
            <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Ultrasound</title>
          <description>Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.&#xD;
Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Incomplete data (lost to follow up)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number with improved (smaller) tear at follow up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Number with resolved tear at follow up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shoulder Pain and Disability Index</title>
        <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
        <time_frame>Week 3 post procedure SPADI Scores for the control and treatment groups.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PRP Injection Into PTRCT</title>
            <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
          </group>
          <group group_id="O2">
            <title>Subacromial Steroid Bursal Injection</title>
            <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Pain and Disability Index</title>
          <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.00" lower_limit="2.31" upper_limit="54.62"/>
                    <measurement group_id="O2" value="18.08" lower_limit="17.69" upper_limit="18.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shoulder Pain and Disability Index</title>
        <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
        <time_frame>Week 6 post procedure SPADI Scores for the treatment and control groups.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PRP Injection Into PTRCT</title>
            <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
          </group>
          <group group_id="O2">
            <title>Subacromial Steroid Bursal Injection</title>
            <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Pain and Disability Index</title>
          <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.00" lower_limit="0" upper_limit="24.62"/>
                    <measurement group_id="O2" value="18.46" lower_limit="15.38" upper_limit="21.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Shoulder Pain and Disability Index</title>
        <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
        <time_frame>6 months post procedure SPADI scores for the treatment and control groups.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PRP Injection Into PTRCT</title>
            <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
          </group>
          <group group_id="O2">
            <title>Subacromial Steroid Bursal Injection</title>
            <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
          </group>
        </group_list>
        <measure>
          <title>Shoulder Pain and Disability Index</title>
          <description>Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.&#xD;
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.&#xD;
2 participants in the control (corticosteroid injection) group completed the study.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" lower_limit="0" upper_limit="4.62"/>
                    <measurement group_id="O2" value="7.31" lower_limit="3.08" upper_limit="11.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were observed and monitored for adverse events up to 6 months post-procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PRP Injection Into PTRCT</title>
          <description>Treatment - PRP injection&#xD;
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.&#xD;
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.</description>
        </group>
        <group group_id="E2">
          <title>Subacromial Steroid Bursal Injection</title>
          <description>Current standard of care for treatment of resistant partial thickness rotator cuff tears&#xD;
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Breanna Willeford, DO</name_or_title>
      <organization>University of Alabama at Birmingham</organization>
      <phone>205-934-4131</phone>
      <email>breannawilleford@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02246530
org study id: F131231006
nct id: NCT02246530
lead sponsor: 
has dmc: No
The goal of this project is to identify an effective and conservative approach to treating
      partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical
      correction needed.
Based off literature and clinical practice, the majority of rotator cuff tears continue to
      progress to surgical correction despite conservative measures. These include physical
      therapy, medication management and minimally invasive procedures such as subacromial bursa
      injections and intra-articular injections with steroids. Recently a popular treatment of
      common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and
      has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich
      Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB
      Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid
      injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are
      ultrasound imaging, pain and disability over the course of 6 months.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Diagnostic Ultrasound
time frame: 6 months post procedure
description: Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study.
Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
measure: Shoulder Pain and Disability Index
time frame: Week 3 post procedure SPADI Scores for the control and treatment groups.
description: Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
measure: Shoulder Pain and Disability Index
time frame: Week 6 post procedure SPADI Scores for the treatment and control groups.
description: Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
measure: Shoulder Pain and Disability Index
time frame: 6 months post procedure SPADI scores for the treatment and control groups.
description: Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%.
In the PRP (platelet rich plasma injection) group we had 5 participants completed the study.
2 participants in the control (corticosteroid injection) group completed the study.
arm group label: PRP injection into PTRCT
arm group type: Active Comparator
description: Treatment - PRP injection
arm group label: Subacromial steroid bursal injection
arm group type: Active Comparator
description: Current standard of care for treatment of resistant partial thickness rotator cuff tears
intervention type: Procedure
intervention name: PRP injection into PTRCT
description: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
arm group label: PRP injection into PTRCT
other name: Biologics
intervention type: Drug
intervention name: Subacromial steroid bursal injection
description: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
arm group label: Subacromial steroid bursal injection
other name: Procedure
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Breanna Willeford, DO
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Breanna Willeford
investigator title: Resident Physician
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 