<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/NCT02986646</url>
  </required_header>
  <id_info>
    <org_study_id>16-280</org_study_id>
    <secondary_id>17-022</secondary_id>
    <nct_id>NCT02986646</nct_id>
  </id_info>
  <brief_title>Comparison of Intra-articular and Intra-tendinous Injections for Treatment of Lateral Epicondylitis</brief_title>
  <official_title>Comparison of Intra-articular and Intra-tendinous Injections for Treatment of Lateral Epicondylitis: A Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri, Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri, Kansas City</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>
      Lateral epicondylitis, commonly known as &quot;tennis elbow&quot; is a common cause of elbow pain&#xD;
      encountered in primary care and specialty clinics. Although lateral epicondylitis is common,&#xD;
      little consensus exists on the best way to treat it. Historically 80% of patients will get&#xD;
      better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to&#xD;
      efficacy of injections, recent large, prospective, randomized studies have shown minor&#xD;
      improvements in the short term, but no long term benefits when compared to saline injection.&#xD;
      Consistently, intra-articular injections have not been reported. The investigators suspect&#xD;
      that elbow joint inflammation may be an underappreciated source of pain in lateral&#xD;
      epicondylitis. The investigators' hypothesis is that patients receiving intra-articular&#xD;
      injections will have greater improvement compared to patients receiving either no injection&#xD;
      or an intra-tendinous injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Lateral epicondylitis, commonly known as &quot;tennis elbow&quot; is a common cause of elbow&#xD;
      pain, occurring in 1-3% of adults each year. It is a common pathology encountered in primary&#xD;
      care, as well as specialty clinics. The typical patient is in his or her 4th-5th decade.&#xD;
      Males and females are affected equally and the dominant arm is more commonly involved.&#xD;
      Patients participating in sports or work related activities involving repetitive forearm&#xD;
      rotation with the elbow extended are at high risk for developing symptoms. Symptom onset is&#xD;
      insidious and related to repetitive microtrauma, similar to other chronic overuse&#xD;
      tendinopathies. Patients classically present with tenderness over the lateral aspect of the&#xD;
      elbow, just distal and anterior o the lateral epicondyle, at the origins of the extensor&#xD;
      carpi radialis brevis (ECRB) and the extensor digitorum communis (EDC) muscles. Pain is&#xD;
      worsened with resisted wrist and finger extension. 1,2 Much of the information the&#xD;
      investigators have regarding the lateral epicondylitis is from the work of Nirschl and&#xD;
      colleagues. The etiology of lateral epicondylitis is believed to result from small tears of&#xD;
      the ECRB origin from repetitive microtrauma. Gross examination reveals grayish, immature scar&#xD;
      tissue that appears shiny, edematous and friable. Histologic analysis reveals what has been&#xD;
      termed &quot;angiofibroblastic hyperplasia&quot; of the ECRB tendon origin. There are no inflammatory&#xD;
      cells noted on histology, putting into question the classification of lateral epicondylitis&#xD;
      as an inflammatory condition.3-6 Baker et al have noted consistent capsular changes seen on&#xD;
      arthroscopy and developed a classification system, hinting that another source of pain may be&#xD;
      inside the joint.7,8 Early authors described a mass of grayish tissue under the ECRB origin,&#xD;
      intimate with the joint capsule. It may be that this tissue causes capsular inflammation,&#xD;
      leading to elbow pain.9 Although lateral epicondylitis is common, little consensus exists on&#xD;
      the best way to treat it. Historic teaching is that 80% of patients will get better with&#xD;
      non-operative treatments, ranging from relative rest, NSAIDs, bracing and injections. There&#xD;
      will be approximately 4-11% of patients, however, that will require operative treatment&#xD;
      before symptom resolution.1 Current mainstays of treatment are non-operative. Many patients&#xD;
      do get better with rest and activity avoidance. Counterforce braces do not lead to quicker&#xD;
      recovery, however, they do allow for more forceful activity during that recovery period.10&#xD;
      NSAIDs have not shown added benefit long term either.1,2 There has been significant interest&#xD;
      in the efficacy of injections in treatment of both acute and chronic lateral epicondylitis.&#xD;
      Steroid injections have been used as standard treatment for decades. Anecdotally, patients do&#xD;
      well with injections. Recent large, prospective, randomized studies have shown minor&#xD;
      improvements in the short term, but no long term benefits when compared to saline&#xD;
      injection.11-15 Protocols for these studies varied greatly, both in steroid utilized and&#xD;
      injection technique. Common injection techniques included injecting at the point of maximal&#xD;
      tenderness versus at the ECRB origin. Additionally, some authors injected a single time,&#xD;
      whereas others used a peppering technique, with one skin entry point and multiple entry&#xD;
      points in the muscle. Consistently, however, no intra-articular injections were reported. The&#xD;
      investigator suspect that elbow joint inflammation may be an underappreciated source of pain&#xD;
      in lateral epicondylitis. Our hypothesis is that patients receiving intra-articular&#xD;
      injections will have greater improvement compared to patients receiving either no injection&#xD;
      or an intra-tendinous injection.&#xD;
&#xD;
      Statement of Objectives&#xD;
&#xD;
        1. To directly compare outcomes of patients with lateral epicondylitis who receive one of&#xD;
           three treatment options: 1. physical therapy and rest 2. physical therapy and&#xD;
           intra-tendinous corticosteroid injection or 3. physical therapy and intra-articular&#xD;
           corticosteroid injection.&#xD;
&#xD;
        2. To blind both patient and assessing physician/nurse research coordinator to the&#xD;
           treatment that was received for the duration of the study, in order to reduce the effect&#xD;
           of any potential bias.&#xD;
&#xD;
        3. To collect outcome data, both subjectively from the patient using proven outcome&#xD;
           measures, and objectively from regularly spaced follow up visits with blinded assessors.&#xD;
&#xD;
        4. To collect and comment on data from the three treatment groups regarding outcomes&#xD;
           related to pain scores, functional outcomes and recurrence of symptoms.&#xD;
&#xD;
      Materials &amp; Methods This will be a randomized, double-blind, controlled trial comparing&#xD;
      patients who receive physical therapy and rest, physical therapy and intra-tendinous&#xD;
      corticosteroid injection or physical therapy and intra-articular corticosteroid injection for&#xD;
      the treatment of lateral epicondylitis. To our knowledge there are no level I or II studies&#xD;
      evaluating intra-articular elbow injections in the literature. All patients will be treated&#xD;
      at one hospital system at one of 2 locations Truman Medical Center-Hospital Hill (TMC-HH) or&#xD;
      Truman Medical Center- Lakewood (TMC-LW), by the principal investigator Our goal is to enroll&#xD;
      patients who are seeking care from either a primary care sports medicine physician or&#xD;
      orthopaedic surgeon for their persistent and limiting elbow pain. Potential subjects who meet&#xD;
      inclusion criteria will be approached about participating in the study. Enrollment will&#xD;
      continue until sufficient numbers have been reached to determine a significant difference.&#xD;
      Based on our power analysis a total of 82 patients will be enrolled in the study.&#xD;
&#xD;
      Lateral epicondylitis is a clinical diagnosis.1,2 In our patients, diagnosis will be made&#xD;
      based on a thorough history and physical examination. Patients with lateral epicondylitis are&#xD;
      typically present in the 4th or 5th decade of life with vague, lateral elbow pain. The pain&#xD;
      is of insidious onset without a singular inciting event. Symptoms are typically in the&#xD;
      dominant arm and occur in patients that perform activities involving repeated wrist extension&#xD;
      against resistance. Patients typically do not have mechanical symptoms as is seen with loose&#xD;
      bodies or osteochondral lesions. Neurologic deficits or alterations are not seen with this&#xD;
      condition. Systemic inflammatory diagnoses, such as rheumatoid arthritis or systemic lupus&#xD;
      erythematosus can have widespread vague joint pains that can confound the diagnosis of&#xD;
      lateral elbow pain. Patients with these conditions will be excluded.&#xD;
&#xD;
      On physical examination, patients will have tenderness about the lateral elbow, typically at&#xD;
      the origin of the ECRB tendon just distal to the lateral epicondyle. This pain will be&#xD;
      exacerbated by resisted extension of the wrist, and/or resisted extension of the long finger.&#xD;
      In rare cases elbow ROM will be limited. Standard elbow radiographs will be obtained to rule&#xD;
      out fracture, arthritis, intra-articular loose body, deformity, osteonecrosis, osteochondral&#xD;
      lesion, neoplasm and subtle instability. Posterolateral rotatory instability (PLRI) of the&#xD;
      elbow is another source of lateral elbow pain, and posterolateral drawer testing will be&#xD;
      performed on all patients to rule out this condition. Although cubital tunnel syndrome&#xD;
      typically causes medial elbow pain, it can present with non-focal, vague pain. A combination&#xD;
      of a thorough neurologic exam of the distal extremity along with compression of the cubital&#xD;
      tunnel and presence or absence of a Tinel's sign at the elbow will be used to diagnosis the&#xD;
      presence of this condition. Patients who have concern for shoulder or wrist pathology or&#xD;
      cervical spine pathology will be excluded from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PRTEE (Patient Rated Tennis Elbow Evaluation)</measure>
    <time_frame>2 years</time_frame>
    <description>The primary analysis will compare the PRTEE scores of each group at 2 years post-enrollment.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Lateral Epicondylitis</condition>
  <arm_group>
    <arm_group_label>physical therapy (PT) and rest</arm_group_label>
    <description>This group of subjects will be prescribed a physical therapy home exercise program and rest (of the injured elbow).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT and intra-tendinous steroid injection</arm_group_label>
    <description>This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-tendinous corticosteroid injection into the area of the ECRB origin (of the injured elbow).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PT and intra-articular steroid injection</arm_group_label>
    <description>This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-articular corticosteroid injection into the elbow joint (of the injured elbow).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are seeking care from either a primary care sports medicine physician or&#xD;
        orthopaedic surgeon for their persistent and limiting elbow pain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of lateral epicondylitis based on 2 or more of the following&#xD;
             diagnostic criteria: tenderness over the lateral epicondyle; pain with resisted wrist&#xD;
             extension; pain with resisted long finger extension.&#xD;
&#xD;
          -  Symptoms lasting a minimum of 6 weeks&#xD;
&#xD;
          -  Pain score of &gt;= 3/10 using the Visual Analog Scale (VAS)&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior elbow surgery&#xD;
&#xD;
          -  History elbow fracture within the past year&#xD;
&#xD;
          -  Elbow instability on physical examination&#xD;
&#xD;
          -  Elbow arthritis on radiographs&#xD;
&#xD;
          -  Compressive neuropathy in the affected extremity (i.e.carpal tunnel, cubital tunnel)&#xD;
&#xD;
          -  Evidence of cervical myelopathy, radiculopathy or brachial plexopathy&#xD;
&#xD;
          -  History of systemic inflammatory condition (i.e. rheumatoid arthritis or systemic&#xD;
             lupus erythematosus)&#xD;
&#xD;
          -  Allergy to study administered medications (steroid or lidocaine)&#xD;
&#xD;
          -  Neoplasm&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Inability to comply with study protocols and follow up.&#xD;
&#xD;
          -  Pregnant female&#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>Akin Cil</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri Kansas City, Department of Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Truman Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri, Kansas City</investigator_affiliation>
    <investigator_full_name>Akin Cil</investigator_full_name>
    <investigator_title>Franklin D. Dickson Associate Professor, Vice Chairman, Department of Orthopaedic Surgery, Truman Medical Centers</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986646
org study id: 16-280
secondary id: 17-022
nct id: NCT02986646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lateral epicondylitis, commonly known as "tennis elbow" is a common cause of elbow pain
      encountered in primary care and specialty clinics. Although lateral epicondylitis is common,
      little consensus exists on the best way to treat it. Historically 80% of patients will get
      better with non-operative treatments (rest, NSAIDS, bracing and injections). In regard to
      efficacy of injections, recent large, prospective, randomized studies have shown minor
      improvements in the short term, but no long term benefits when compared to saline injection.
      Consistently, intra-articular injections have not been reported. The investigators suspect
      that elbow joint inflammation may be an underappreciated source of pain in lateral
      epicondylitis. The investigators' hypothesis is that patients receiving intra-articular
      injections will have greater improvement compared to patients receiving either no injection
      or an intra-tendinous injection.
Background Lateral epicondylitis, commonly known as "tennis elbow" is a common cause of elbow
      pain, occurring in 1-3% of adults each year. It is a common pathology encountered in primary
      care, as well as specialty clinics. The typical patient is in his or her 4th-5th decade.
      Males and females are affected equally and the dominant arm is more commonly involved.
      Patients participating in sports or work related activities involving repetitive forearm
      rotation with the elbow extended are at high risk for developing symptoms. Symptom onset is
      insidious and related to repetitive microtrauma, similar to other chronic overuse
      tendinopathies. Patients classically present with tenderness over the lateral aspect of the
      elbow, just distal and anterior o the lateral epicondyle, at the origins of the extensor
      carpi radialis brevis (ECRB) and the extensor digitorum communis (EDC) muscles. Pain is
      worsened with resisted wrist and finger extension. 1,2 Much of the information the
      investigators have regarding the lateral epicondylitis is from the work of Nirschl and
      colleagues. The etiology of lateral epicondylitis is believed to result from small tears of
      the ECRB origin from repetitive microtrauma. Gross examination reveals grayish, immature scar
      tissue that appears shiny, edematous and friable. Histologic analysis reveals what has been
      termed "angiofibroblastic hyperplasia" of the ECRB tendon origin. There are no inflammatory
      cells noted on histology, putting into question the classification of lateral epicondylitis
      as an inflammatory condition.3-6 Baker et al have noted consistent capsular changes seen on
      arthroscopy and developed a classification system, hinting that another source of pain may be
      inside the joint.7,8 Early authors described a mass of grayish tissue under the ECRB origin,
      intimate with the joint capsule. It may be that this tissue causes capsular inflammation,
      leading to elbow pain.9 Although lateral epicondylitis is common, little consensus exists on
      the best way to treat it. Historic teaching is that 80% of patients will get better with
      non-operative treatments, ranging from relative rest, NSAIDs, bracing and injections. There
      will be approximately 4-11% of patients, however, that will require operative treatment
      before symptom resolution.1 Current mainstays of treatment are non-operative. Many patients
      do get better with rest and activity avoidance. Counterforce braces do not lead to quicker
      recovery, however, they do allow for more forceful activity during that recovery period.10
      NSAIDs have not shown added benefit long term either.1,2 There has been significant interest
      in the efficacy of injections in treatment of both acute and chronic lateral epicondylitis.
      Steroid injections have been used as standard treatment for decades. Anecdotally, patients do
      well with injections. Recent large, prospective, randomized studies have shown minor
      improvements in the short term, but no long term benefits when compared to saline
      injection.11-15 Protocols for these studies varied greatly, both in steroid utilized and
      injection technique. Common injection techniques included injecting at the point of maximal
      tenderness versus at the ECRB origin. Additionally, some authors injected a single time,
      whereas others used a peppering technique, with one skin entry point and multiple entry
      points in the muscle. Consistently, however, no intra-articular injections were reported. The
      investigator suspect that elbow joint inflammation may be an underappreciated source of pain
      in lateral epicondylitis. Our hypothesis is that patients receiving intra-articular
      injections will have greater improvement compared to patients receiving either no injection
      or an intra-tendinous injection.

      Statement of Objectives

        1. To directly compare outcomes of patients with lateral epicondylitis who receive one of
           three treatment options: 1. physical therapy and rest 2. physical therapy and
           intra-tendinous corticosteroid injection or 3. physical therapy and intra-articular
           corticosteroid injection.

        2. To blind both patient and assessing physician/nurse research coordinator to the
           treatment that was received for the duration of the study, in order to reduce the effect
           of any potential bias.

        3. To collect outcome data, both subjectively from the patient using proven outcome
           measures, and objectively from regularly spaced follow up visits with blinded assessors.

        4. To collect and comment on data from the three treatment groups regarding outcomes
           related to pain scores, functional outcomes and recurrence of symptoms.

      Materials & Methods This will be a randomized, double-blind, controlled trial comparing
      patients who receive physical therapy and rest, physical therapy and intra-tendinous
      corticosteroid injection or physical therapy and intra-articular corticosteroid injection for
      the treatment of lateral epicondylitis. To our knowledge there are no level I or II studies
      evaluating intra-articular elbow injections in the literature. All patients will be treated
      at one hospital system at one of 2 locations Truman Medical Center-Hospital Hill (TMC-HH) or
      Truman Medical Center- Lakewood (TMC-LW), by the principal investigator Our goal is to enroll
      patients who are seeking care from either a primary care sports medicine physician or
      orthopaedic surgeon for their persistent and limiting elbow pain. Potential subjects who meet
      inclusion criteria will be approached about participating in the study. Enrollment will
      continue until sufficient numbers have been reached to determine a significant difference.
      Based on our power analysis a total of 82 patients will be enrolled in the study.

      Lateral epicondylitis is a clinical diagnosis.1,2 In our patients, diagnosis will be made
      based on a thorough history and physical examination. Patients with lateral epicondylitis are
      typically present in the 4th or 5th decade of life with vague, lateral elbow pain. The pain
      is of insidious onset without a singular inciting event. Symptoms are typically in the
      dominant arm and occur in patients that perform activities involving repeated wrist extension
      against resistance. Patients typically do not have mechanical symptoms as is seen with loose
      bodies or osteochondral lesions. Neurologic deficits or alterations are not seen with this
      condition. Systemic inflammatory diagnoses, such as rheumatoid arthritis or systemic lupus
      erythematosus can have widespread vague joint pains that can confound the diagnosis of
      lateral elbow pain. Patients with these conditions will be excluded.

      On physical examination, patients will have tenderness about the lateral elbow, typically at
      the origin of the ECRB tendon just distal to the lateral epicondyle. This pain will be
      exacerbated by resisted extension of the wrist, and/or resisted extension of the long finger.
      In rare cases elbow ROM will be limited. Standard elbow radiographs will be obtained to rule
      out fracture, arthritis, intra-articular loose body, deformity, osteonecrosis, osteochondral
      lesion, neoplasm and subtle instability. Posterolateral rotatory instability (PLRI) of the
      elbow is another source of lateral elbow pain, and posterolateral drawer testing will be
      performed on all patients to rule out this condition. Although cubital tunnel syndrome
      typically causes medial elbow pain, it can present with non-focal, vague pain. A combination
      of a thorough neurologic exam of the distal extremity along with compression of the cubital
      tunnel and presence or absence of a Tinel's sign at the elbow will be used to diagnosis the
      presence of this condition. Patients who have concern for shoulder or wrist pathology or
      cervical spine pathology will be excluded from the study.
observational model: Case-Only
time perspective: Prospective
measure: PRTEE (Patient Rated Tennis Elbow Evaluation)
time frame: 2 years
description: The primary analysis will compare the PRTEE scores of each group at 2 years post-enrollment.
arm group label: physical therapy (PT) and rest
description: This group of subjects will be prescribed a physical therapy home exercise program and rest (of the injured elbow).
arm group label: PT and intra-tendinous steroid injection
description: This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-tendinous corticosteroid injection into the area of the ECRB origin (of the injured elbow).
arm group label: PT and intra-articular steroid injection
description: This group of subjects will be prescribed a physical therapy home exercise program and will received an intra-articular corticosteroid injection into the elbow joint (of the injured elbow).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Akin Cil
role: Principal Investigator
affiliation: University of Missouri Kansas City, Department of Orthopaedic Surgery
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri, Kansas City
investigator full name: Akin Cil
investigator title: Franklin D. Dickson Associate Professor, Vice Chairman, Department of Orthopaedic Surgery, Truman Medical Centers
mesh term: Tennis Elbow
sharing ipd: No