<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/NCT03770546</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002242</org_study_id>
    <nct_id>NCT03770546</nct_id>
  </id_info>
  <brief_title>Amnion-Based Injections in the Shoulder</brief_title>
  <official_title>Amnion-Based Injections in the Shoulder for Adhesive Capsulitis and Osteoarthritis</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteoarthritis (OA) of the shoulder is a common debilitating condition affecting up to 5% of&#xD;
      the general population and as much as 32% of patients over 60 years of age. Clinically, OA is&#xD;
      diagnosed by a combination of symptoms, such as slow onset of progressively worsening&#xD;
      shoulder pain and stiffness over months to years (often with a history of minor trauma), and&#xD;
      pain with activity. Physical exam may show tenderness and swelling, muscle atrophy, and&#xD;
      decreased range of motion. Adhesive capsulitis (also called &quot;Frozen Shoulder&quot;) is another&#xD;
      common shoulder condition, affecting 2-5% of the general population. Frozen shoulder presents&#xD;
      with a similar combination of symptoms, such as inability to sleep on the side of the&#xD;
      affected shoulder, shoulder pain, and pain at extremes of active and passive range of motion.&#xD;
&#xD;
      Despite the ubiquitous nature of these conditions, various non-operative treatment modalities&#xD;
      have been employed in their managements without a clearly superior alternative. The usual&#xD;
      initial treatment strategy for both of these conditions is the same: a trial of conservative&#xD;
      management. Conservative management includes physical therapy, supervised neglect,&#xD;
      over-the-counter pain medications (including NSAIDs, like Advil), oral and intra-articular&#xD;
      corticosteroid use (steroids), hydrodilatation (capsular distension to rupture),&#xD;
      intra-articular hyaluronic acid injections. Despite several years of employing different&#xD;
      modes of treatment, there is no evidence that places one treatment modality over the others,&#xD;
      and patients will often need surgery.&#xD;
&#xD;
      Amniotic fluid's apparent ability to improve blood flow, re-organize collagen, and protect&#xD;
      cartilage makes it theoretically ideal for disorders like osteoarthritis and frozen shoulder.&#xD;
      In recent studies, it has shown efficacy in promoting ligament healing in the knee and&#xD;
      promoting tendon and degenerative joint pain reduction and functional improvement. It has&#xD;
      been useful as a material for cartilage repair when used as a scaffold. Intra-articular&#xD;
      amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the&#xD;
      shoulder or frozen shoulder. To test this hypothesis, intra-articular amnion will be injected&#xD;
      into the shoulders of 20 patients with moderate to severe osteoarthritis and 20 patients with&#xD;
      frozen shoulder. The hypothesis is that improvement in short-term outcomes (pain, function,&#xD;
      and range of motion) will be identified following amnion injection in these patients. The&#xD;
      goal of this study is to lead to larger randomized controlled trials evaluating amnion&#xD;
      against current forms of treatment for osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amnion injections are commonly performed by community orthopaedic surgeons for many&#xD;
      conditions, including osteoarthritis, rotator cuff tears, tendinitis, and others. Human&#xD;
      placental tissue has been reported to contain biochemical and immunologic properties that&#xD;
      play key roles in regulation of the inflammation-healing cycle. Amnion-chorion membrane has&#xD;
      been shown to contain high concentrations of collagens, transforming growth factor beta&#xD;
      suppressors, and inhibitors of matrix metalloproteinases that provide strong scaffolding,&#xD;
      suppress scar formation, and regulate tissue remodeling, respectively. The amnion injection&#xD;
      is a morselized, flowable tissue allograft derived from human amniotic tissues. The amniotic&#xD;
      tissue comes from placenta, donated by pre-screened healthy women undergoing scheduled&#xD;
      C-sections. It is processed into a form that can be injected.&#xD;
&#xD;
      Similarly, in a recent study injection of micronized dehydrated human amnion-chorion membrane&#xD;
      slowed the development of cartilaginous lesions and led to a decreased number of erosions in&#xD;
      a rat model of osteoarthritis. There is also an emerging body of literature investigating its&#xD;
      use in osteoarthritis of the knee, with promising early results. In one study human amniotic&#xD;
      suspension allograft was injected into patients with symptomatic knee osteoarthritis. No&#xD;
      significant reactions were noted and the feasibility of injection for treatment of the&#xD;
      osteoarthritis in the knee was demonstrated. Another study found that human amniotic fluid&#xD;
      had a positive effect on tibia fracture healing through a rat model. In an osteoarthritis&#xD;
      model, injection demonstrated attenuation of cartilage destruction and significant increases&#xD;
      in cartilage thickness and volume. Finally, patients with plantar fasciitis noted significant&#xD;
      improvement in symptoms, and American Orthopaedic Foot and Ankle Society Hindfoot scores&#xD;
      (pain, function, alignment) compared to controls. These studies suggest the safety and&#xD;
      efficacy of amnion-based injections in treating specific orthopaedic pathologies.&#xD;
&#xD;
      Osteoarthritis and adhesive capsulitis are two common pathologies of the shoulder. There is a&#xD;
      variety of options for conservative management including physical therapy, pain medications,&#xD;
      and injections, but no evidence that places one modality over another. The purpose of this&#xD;
      study is the evaluate the effectiveness of amniotic fluid injection in treating these&#xD;
      pathologies. In this study intra-articular amnion will be injected into the shoulders of&#xD;
      patients with moderate to severe osteoarthritis and patients with frozen shoulder and&#xD;
      assessing pain, function and range of motion over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Failure of institution to reach agreement with company supplying injections&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 30, 2021</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Measured via goniometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Measured via dynamometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain and Disability Index for shoulder pain and function</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure of shoulder pain and function. Score is between 0% and 100%. There are 5 questions in on the pain scale and 8 questions on the disability scale, each rated from 0-10. Pain score is the sum of the ratings of the 5 question out of 50 converted to a percentage (0-100%). Disability score is the sum of the ratings of the 8 questions out of 80 converted to a percentage (0-100%). The overall score is a sum of the ratings for all 13 questions out of 130 converted to a percentage (0-100%). A higher score indicates worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form Health Survey 36 for physical health, mental health, pain and limitation of activities</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure of physical health, mental health, pain and limitation of activities. There is a physical health score and mental health score, each a number from 0-100. A higher score indicates better health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form of shoulder function</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure assessing shoulder function with a score between 0 and 100. A higher score represents better shoulder function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test of shoulder function</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure of shoulder function. It is a set of 12 yes/no questions. The score is calculated as the number of &quot;yes&quot; response out of 12 converted to a percentage (0-100%). A higher score represents better shoulder function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disabilities of the Arm, Shoulder, and Hand Questionnaire of arm, shoulder, and hand function</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure assessing arm, shoulder, and hand function. This is a score ranging from 0-100 with a higher score indicating worse function of the upper extremities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale for Pain</measure>
    <time_frame>0-12 months after injection</time_frame>
    <description>Patient reported outcome measure assessing pain with a scale from 0-100, a higher score indicating greater pain.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis of the Shoulder</condition>
  <condition>Adhesive Capsulitis</condition>
  <arm_group>
    <arm_group_label>Osteoarthritis - Amnion Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoarthritis - Betamethasone Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adhesive Capsulitis - Amnion Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adhesive Capsulitis - Betamethasone Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Amnion Injection</intervention_name>
    <description>Per the manufacturer, this is considered an injection of tissue/organic matter.</description>
    <arm_group_label>Adhesive Capsulitis - Amnion Injection</arm_group_label>
    <arm_group_label>Osteoarthritis - Amnion Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone injection</intervention_name>
    <description>Routine steroid injection for these pathologies. Betamethasone Sodium Phosphate and Betamethasone Acetate injection.</description>
    <arm_group_label>Adhesive Capsulitis - Betamethasone Injection</arm_group_label>
    <arm_group_label>Osteoarthritis - Betamethasone Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or greater&#xD;
&#xD;
          -  Clinical diagnosis of adhesive capsulitis, clinically in the frozen phase at the time&#xD;
             of enrollment OR Clinical diagnosis of osteoarthritis of the shoulder.&#xD;
&#xD;
          -  Symptoms for 2-6 months&#xD;
&#xD;
          -  Failure of conservative management.&#xD;
&#xD;
          -  &gt; 25% reduction in active range of motion in &gt;= 2/3 planes of motion in the affected&#xD;
             shoulder.&#xD;
&#xD;
          -  No alternative medical explanation for symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alternative explanation for symptoms including neurological disorders, or like&#xD;
             conditions&#xD;
&#xD;
          -  Pregnancy or desire to become pregnant&#xD;
&#xD;
          -  Discretion of the enrolling clinician&#xD;
&#xD;
        Exclusion in Amnion Injection Group:&#xD;
&#xD;
        • Intra-articular steroid injection within 6 months of enrollment or surgical intervention&#xD;
        in the within 12 months of enrollment in affected shoulder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bal A, Eksioglu E, Gulec B, Aydog E, Gurcay E, Cakci A. Effectiveness of corticosteroid injection in adhesive capsulitis. Clin Rehabil. 2008 Jun;22(6):503-12. doi: 10.1177/0269215508086179.</citation>
    <PMID>18511530</PMID>
  </reference>
  <reference>
    <citation>Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.</citation>
    <PMID>12632439</PMID>
  </reference>
  <reference>
    <citation>Lorbach O, Anagnostakos K, Scherf C, Seil R, Kohn D, Pape D. Nonoperative management of adhesive capsulitis of the shoulder: oral cortisone application versus intra-articular cortisone injections. J Shoulder Elbow Surg. 2010 Mar;19(2):172-9. doi: 10.1016/j.jse.2009.06.013. Epub 2009 Oct 1.</citation>
    <PMID>19800262</PMID>
  </reference>
  <reference>
    <citation>Willett NJ, Thote T, Lin AS, Moran S, Raji Y, Sridaran S, Stevens HY, Guldberg RE. Intra-articular injection of micronized dehydrated human amnion/chorion membrane attenuates osteoarthritis development. Arthritis Res Ther. 2014 Feb 6;16(1):R47. doi: 10.1186/ar4476.</citation>
    <PMID>24499554</PMID>
  </reference>
  <reference>
    <citation>Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.</citation>
    <PMID>26683979</PMID>
  </reference>
  <reference>
    <citation>Kerimoglu S, Livaoglu M, Sonmez B, Yulug E, Aynaci O, Topbas M, Yarar S. Effects of human amniotic fluid on fracture healing in rat tibia. J Surg Res. 2009 Apr;152(2):281-7. doi: 10.1016/j.jss.2008.02.028. Epub 2008 Mar 18.</citation>
    <PMID>18499130</PMID>
  </reference>
  <reference>
    <citation>Raines AL, Shih MS, Chua L, Su CW, Tseng SC, O'Connell J. Efficacy of Particulate Amniotic Membrane and Umbilical Cord Tissues in Attenuating Cartilage Destruction in an Osteoarthritis Model. Tissue Eng Part A. 2017 Jan;23(1-2):12-19. doi: 10.1089/ten.TEA.2016.0088. Epub 2016 Nov 18.</citation>
    <PMID>27707109</PMID>
  </reference>
  <reference>
    <citation>Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int. 2013 Oct;34(10):1332-9. doi: 10.1177/1071100713502179. Epub 2013 Aug 14.</citation>
    <PMID>23945520</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</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>Eugene Willis Brabston</investigator_full_name>
    <investigator_title>Associate Professor, Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
  </intervention_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/NCT03770546
org study id: IRB-300002242
nct id: NCT03770546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis (OA) of the shoulder is a common debilitating condition affecting up to 5% of
      the general population and as much as 32% of patients over 60 years of age. Clinically, OA is
      diagnosed by a combination of symptoms, such as slow onset of progressively worsening
      shoulder pain and stiffness over months to years (often with a history of minor trauma), and
      pain with activity. Physical exam may show tenderness and swelling, muscle atrophy, and
      decreased range of motion. Adhesive capsulitis (also called "Frozen Shoulder") is another
      common shoulder condition, affecting 2-5% of the general population. Frozen shoulder presents
      with a similar combination of symptoms, such as inability to sleep on the side of the
      affected shoulder, shoulder pain, and pain at extremes of active and passive range of motion.

      Despite the ubiquitous nature of these conditions, various non-operative treatment modalities
      have been employed in their managements without a clearly superior alternative. The usual
      initial treatment strategy for both of these conditions is the same: a trial of conservative
      management. Conservative management includes physical therapy, supervised neglect,
      over-the-counter pain medications (including NSAIDs, like Advil), oral and intra-articular
      corticosteroid use (steroids), hydrodilatation (capsular distension to rupture),
      intra-articular hyaluronic acid injections. Despite several years of employing different
      modes of treatment, there is no evidence that places one treatment modality over the others,
      and patients will often need surgery.

      Amniotic fluid's apparent ability to improve blood flow, re-organize collagen, and protect
      cartilage makes it theoretically ideal for disorders like osteoarthritis and frozen shoulder.
      In recent studies, it has shown efficacy in promoting ligament healing in the knee and
      promoting tendon and degenerative joint pain reduction and functional improvement. It has
      been useful as a material for cartilage repair when used as a scaffold. Intra-articular
      amnion membrane injection may have favorable outcomes in patients with osteoarthritis of the
      shoulder or frozen shoulder. To test this hypothesis, intra-articular amnion will be injected
      into the shoulders of 20 patients with moderate to severe osteoarthritis and 20 patients with
      frozen shoulder. The hypothesis is that improvement in short-term outcomes (pain, function,
      and range of motion) will be identified following amnion injection in these patients. The
      goal of this study is to lead to larger randomized controlled trials evaluating amnion
      against current forms of treatment for osteoarthritis.
Amnion injections are commonly performed by community orthopaedic surgeons for many
      conditions, including osteoarthritis, rotator cuff tears, tendinitis, and others. Human
      placental tissue has been reported to contain biochemical and immunologic properties that
      play key roles in regulation of the inflammation-healing cycle. Amnion-chorion membrane has
      been shown to contain high concentrations of collagens, transforming growth factor beta
      suppressors, and inhibitors of matrix metalloproteinases that provide strong scaffolding,
      suppress scar formation, and regulate tissue remodeling, respectively. The amnion injection
      is a morselized, flowable tissue allograft derived from human amniotic tissues. The amniotic
      tissue comes from placenta, donated by pre-screened healthy women undergoing scheduled
      C-sections. It is processed into a form that can be injected.

      Similarly, in a recent study injection of micronized dehydrated human amnion-chorion membrane
      slowed the development of cartilaginous lesions and led to a decreased number of erosions in
      a rat model of osteoarthritis. There is also an emerging body of literature investigating its
      use in osteoarthritis of the knee, with promising early results. In one study human amniotic
      suspension allograft was injected into patients with symptomatic knee osteoarthritis. No
      significant reactions were noted and the feasibility of injection for treatment of the
      osteoarthritis in the knee was demonstrated. Another study found that human amniotic fluid
      had a positive effect on tibia fracture healing through a rat model. In an osteoarthritis
      model, injection demonstrated attenuation of cartilage destruction and significant increases
      in cartilage thickness and volume. Finally, patients with plantar fasciitis noted significant
      improvement in symptoms, and American Orthopaedic Foot and Ankle Society Hindfoot scores
      (pain, function, alignment) compared to controls. These studies suggest the safety and
      efficacy of amnion-based injections in treating specific orthopaedic pathologies.

      Osteoarthritis and adhesive capsulitis are two common pathologies of the shoulder. There is a
      variety of options for conservative management including physical therapy, pain medications,
      and injections, but no evidence that places one modality over another. The purpose of this
      study is the evaluate the effectiveness of amniotic fluid injection in treating these
      pathologies. In this study intra-articular amnion will be injected into the shoulders of
      patients with moderate to severe osteoarthritis and patients with frozen shoulder and
      assessing pain, function and range of motion over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Range of Motion
time frame: 0-12 months after injection
description: Measured via goniometer
measure: Strength
time frame: 0-12 months after injection
description: Measured via dynamometer
measure: Shoulder Pain and Disability Index for shoulder pain and function
time frame: 0-12 months after injection
description: Patient reported outcome measure of shoulder pain and function. Score is between 0% and 100%. There are 5 questions in on the pain scale and 8 questions on the disability scale, each rated from 0-10. Pain score is the sum of the ratings of the 5 question out of 50 converted to a percentage (0-100%). Disability score is the sum of the ratings of the 8 questions out of 80 converted to a percentage (0-100%). The overall score is a sum of the ratings for all 13 questions out of 130 converted to a percentage (0-100%). A higher score indicates worse outcomes.
measure: Short-Form Health Survey 36 for physical health, mental health, pain and limitation of activities
time frame: 0-12 months after injection
description: Patient reported outcome measure of physical health, mental health, pain and limitation of activities. There is a physical health score and mental health score, each a number from 0-100. A higher score indicates better health.
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form of shoulder function
time frame: 0-12 months after injection
description: Patient reported outcome measure assessing shoulder function with a score between 0 and 100. A higher score represents better shoulder function.
measure: Simple Shoulder Test of shoulder function
time frame: 0-12 months after injection
description: Patient reported outcome measure of shoulder function. It is a set of 12 yes/no questions. The score is calculated as the number of "yes" response out of 12 converted to a percentage (0-100%). A higher score represents better shoulder function.
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire of arm, shoulder, and hand function
time frame: 0-12 months after injection
description: Patient reported outcome measure assessing arm, shoulder, and hand function. This is a score ranging from 0-100 with a higher score indicating worse function of the upper extremities.
measure: Visual Analog Scale for Pain
time frame: 0-12 months after injection
description: Patient reported outcome measure assessing pain with a scale from 0-100, a higher score indicating greater pain.
arm group label: Osteoarthritis - Amnion Injection
arm group type: Experimental
description: BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.
arm group label: Osteoarthritis - Betamethasone Injection
arm group type: Active Comparator
description: Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)
arm group label: Adhesive Capsulitis - Amnion Injection
arm group type: Experimental
description: BioDRestore Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from human amniotic tissues.
arm group label: Adhesive Capsulitis - Betamethasone Injection
arm group type: Active Comparator
description: Betamethasone Sodium Phosphate and Betamethasone Acetate injection (To clarify, this is one formulation/injected solution, not separate solutions/interventions)
intervention type: Biological
intervention name: Amnion Injection
description: Per the manufacturer, this is considered an injection of tissue/organic matter.
arm group label: Adhesive Capsulitis - Amnion Injection
arm group label: Osteoarthritis - Amnion Injection
intervention type: Drug
intervention name: Betamethasone injection
description: Routine steroid injection for these pathologies. Betamethasone Sodium Phosphate and Betamethasone Acetate injection.
arm group label: Adhesive Capsulitis - Betamethasone Injection
arm group label: Osteoarthritis - Betamethasone Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
citation: Bal A, Eksioglu E, Gulec B, Aydog E, Gurcay E, Cakci A. Effectiveness of corticosteroid injection in adhesive capsulitis. Clin Rehabil. 2008 Jun;22(6):503-12. doi: 10.1177/0269215508086179.
PMID: 18511530
citation: Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.
PMID: 12632439
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responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Eugene Willis Brabston
investigator title: Associate Professor, Orthopaedic Surgery
mesh term: Osteoarthritis
mesh term: Bursitis
mesh term: Betamethasone
sharing ipd: No