<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/NCT03835910</url>
  </required_header>
  <id_info>
    <org_study_id>F3157-P</org_study_id>
    <nct_id>NCT03835910</nct_id>
  </id_info>
  <brief_title>A Pragmatic Trial To Determine the Benefit of Exercise Incentives and Corticosteroid Injections in Osteoarthritis of the Knee</brief_title>
  <acronym>MOVE-OK</acronym>
  <official_title>A Pragmatic Trial to Determine the Benefit of Exercise Incentives and Corticosteroid Injections for Osteoarthritis of the Knee</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans.&#xD;
      Management of KOA is challenging as there are few effective treatments other than joint&#xD;
      replacement. Importantly, low levels of physical activity in patients with knee problems&#xD;
      might worsen pain and disability. This study aims to determine the feasibility of using&#xD;
      methods to change behavior that use social incentives and promote physical activity through&#xD;
      playing games and interacting with a web-based platform. The study will also evaluate an&#xD;
      important and widely used treatment, namely corticosteroid injections. Participants will be&#xD;
      randomized into one of 4 arms and will receive a different combination of social incentives&#xD;
      and injections. The study will evaluate which approach is most effective at promoting&#xD;
      physical activity and reducing pain and disability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among&#xD;
      Veterans and accounts for high morbidity and high costs for the VA. Management of KOA is&#xD;
      challenging as there are few consistently effective treatments other than joint replacement.&#xD;
      Importantly, chronic reductions in physical activity in patients with KOA may worsen pain,&#xD;
      physical function, and exacerbate the metabolic consequences of obesity. Moreover, the&#xD;
      greater mortality observed in symptomatic knee OA populations is likely mediated through its&#xD;
      effect on physical activity. The current proposal aims to derive preliminary data to support&#xD;
      a large pragmatic trial testing the impact of interventions geared towards improving physical&#xD;
      activity and function in KOA patients.&#xD;
&#xD;
      Promoting physical activity has been shown to be helpful in reducing pain and improving&#xD;
      function in KOA and other groups. However, promoting behavioral change in the arthritis&#xD;
      population is a significant challenge. The group has shown that social incentives [and&#xD;
      gamification] derived from concepts from the field of behavioral economics to promote&#xD;
      behavioral change and increase physical activity can be both practical and effective in other&#xD;
      settings. The investigators' group is studying incentives in patients with inflammatory&#xD;
      arthritis with the goal of addressing fatigue, pain, and deficits in physical function. The&#xD;
      incentivization of physical activity using this approach represents a novel intervention for&#xD;
      the managing symptoms of KOA and to improving overall health.&#xD;
&#xD;
      Analgesic therapies can help KOA patients participate in exercise therapy. However, whether&#xD;
      corticosteroid injections, a commonly used medical therapy for KOA pain, has a positive&#xD;
      impact of physical activity is unknown and is an additional important question addressed by&#xD;
      the current proposal. Despite widespread use, definitive data demonstrating a consistent&#xD;
      benefit of corticosteroids are lacking. A large randomized trial recently tested the effects&#xD;
      of repeated corticosteroids injections every 3 months for a period of 2 years on patient&#xD;
      reported pain as well as progression of disease measured by magnetic resonance imaging (MRI).&#xD;
      This study demonstrated no improvement in pain compared to saline injections. In addition, a&#xD;
      small but statistically significant decline in cartilage thickness on MRI was observed,&#xD;
      raising a concern for side effects. These recent data might suggest that corticosteroid&#xD;
      injections result in more harm than good, and may discourage providers from performing this&#xD;
      intervention. However, there are critical weaknesses to this study. Pain and function were&#xD;
      only assessed at 3-month intervals, while previous trials have suggested that peak benefit is&#xD;
      expected at 4-8 weeks. Moreover, the clinical and biologic significance decrease in cartilage&#xD;
      thickness is unclear.&#xD;
&#xD;
      The investigators propose to fill these important knowledge gaps with an innovative and&#xD;
      efficient pragmatic clinical trial with a factorial and crossover design. A large and&#xD;
      definitive practical trial would lead to better understanding of the clinical effectiveness&#xD;
      of these interventions, the meaningfulness of their combined impact, and the subgroups that&#xD;
      are most likely to derive benefit. This clinical trial of 32-40 patients will leverage unique&#xD;
      resources available through the Penn Center for Innovation to better capture important&#xD;
      patient-reported outcomes in real-time through a web-based platform. The study will also test&#xD;
      the feasibility of a crossover and factorial design to improve efficiency and reduce&#xD;
      confounding. Each patient will receive each intervention (saline, corticosteroids) in random&#xD;
      order over 1 year. A factorial design will be employed and will randomize participants to&#xD;
      receive social incentives with gamification to promote increases in their physical activity.&#xD;
      To accomplish these aims, the investigators will utilize innovative mobile applications for&#xD;
      smart phones and wearable activity trackers through the Way-to-Health platform and assess, in&#xD;
      real time, the impact of the intervention on patient-reported function and pain as well as&#xD;
      physical activity. The technology will allow for the recording of outcomes as they occur,&#xD;
      between clinic visits, thereby avoiding information bias due to poor recall. It will also&#xD;
      provide real-time assessment of symptoms, providing granular assessments of response over&#xD;
      time. The investigative team includes early career investigators with experience conducting&#xD;
      similar trials using this infrastructure. Results will provide preliminary data to power a&#xD;
      large, feasible, and low-cost pragmatic multi-site trial that would lead to practical&#xD;
      implementation. The specific aims of the study are:&#xD;
&#xD;
      Aim 1: To determine the feasibility of recruitment and retention of Veterans with&#xD;
      osteoarthritis of the knee (KOA) in a practical trial using an innovative online trial&#xD;
      platform incorporating mobile activity monitors. The investigators expect to recruit and&#xD;
      retain 32 Veterans within 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>Participants are randomized with a software application to receive social incentives to promote physical activity. They will also be randomized to receive corticosteroid injections in a crossover design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>It is not possible to blind participants to the social incentives they will receive. For the injection aspect of the study, the investigator will be aware of the injection being given but the syringe will be covered to obscure the view of the patient.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change from baseline in weekly average steps per day</measure>
    <time_frame>Measured weekly over 3-10 months</time_frame>
    <description>Steps measured by a wearable activity monitor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Measured bi-weekly over 3-10 months</time_frame>
    <description>KOOS assessed by survey at 2 week intervals. KOOS scores range from 0 to 100 with 0 representing worse knee problems and 100 representing no knee problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS pain intensity score</measure>
    <time_frame>Measured bi-weekly over 3-10 months</time_frame>
    <description>Assessed by survey at 2 week intervals. Scores range from 3-15 and are converted to T-Scores. A high score represents greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Fatigue</measure>
    <time_frame>Measured every 4 weeks over 3-10 months</time_frame>
    <description>Assessed by survey at 4 week intervals</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals.&#xD;
The participants will receive injections in A-B order (corticosteroids, then lidocaine only)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Incentive, Corticosteroid AB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will only receive reminders to sync their activity monitor.&#xD;
The participants will receive injections in A-B order (corticosteroids, then lidocaine only)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals.&#xD;
The participants will receive injections in B-A order (lidocaine only, then corticosteroids)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Incentive, Corticosteroid BA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will only receive reminders to sync their activity monitor.&#xD;
The participants will receive injections in B-A order (lidocaine only, then corticosteroids)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social Incentives and Gamification to Promote Exercise</intervention_name>
    <description>The intervention will provide social incentives and gamification to promote physical activity.</description>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid AB</arm_group_label>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Corticosteroid Injection given in A-B order</intervention_name>
    <description>The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.</description>
    <arm_group_label>No Incentive, Corticosteroid AB</arm_group_label>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid AB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Social Incentive applied</intervention_name>
    <description>No social incentive will be applied</description>
    <arm_group_label>No Incentive, Corticosteroid AB</arm_group_label>
    <arm_group_label>No Incentive, Corticosteroid BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Corticosteroid Injection given in B-A order</intervention_name>
    <description>The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.</description>
    <arm_group_label>No Incentive, Corticosteroid BA</arm_group_label>
    <arm_group_label>Social Incentives and Gamification, Corticosteroid BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans in VA Rheumatology or Orthopedic clinics&#xD;
&#xD;
          -  Chronic knee osteoarthritis&#xD;
&#xD;
          -  Indication for joint injection&#xD;
&#xD;
          -  Previous joint injections for palliation&#xD;
&#xD;
          -  Patient expresses interest in increasing their physical activity&#xD;
&#xD;
          -  Patient is able to walk 1/2 mile per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intra-articular hardware or other contraindication to joint injection&#xD;
&#xD;
          -  Lack of smart phone&#xD;
&#xD;
          -  Acute exacerbation of osteoarthritis or knee pain&#xD;
&#xD;
          -  Unable or unwilling to identify a social sponsor&#xD;
&#xD;
          -  Comorbid condition that precludes safe exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua F. Baker, MD MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corticosteroid injection</keyword>
  <keyword>physical activity</keyword>
  <keyword>pain</keyword>
  <keyword>disability</keyword>
  <keyword>behavioral incentives</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03835910/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 2, 2022</submitted>
    <returned>March 14, 2023</returned>
    <submitted>March 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03835910
org study id: F3157-P
nct id: NCT03835910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Knee osteoarthritis (KOA) is one of the most common and disabling conditions among Veterans.
      Management of KOA is challenging as there are few effective treatments other than joint
      replacement. Importantly, low levels of physical activity in patients with knee problems
      might worsen pain and disability. This study aims to determine the feasibility of using
      methods to change behavior that use social incentives and promote physical activity through
      playing games and interacting with a web-based platform. The study will also evaluate an
      important and widely used treatment, namely corticosteroid injections. Participants will be
      randomized into one of 4 arms and will receive a different combination of social incentives
      and injections. The study will evaluate which approach is most effective at promoting
      physical activity and reducing pain and disability.
Knee osteoarthritis (KOA) is one of the most prevalent and disabling conditions among
      Veterans and accounts for high morbidity and high costs for the VA. Management of KOA is
      challenging as there are few consistently effective treatments other than joint replacement.
      Importantly, chronic reductions in physical activity in patients with KOA may worsen pain,
      physical function, and exacerbate the metabolic consequences of obesity. Moreover, the
      greater mortality observed in symptomatic knee OA populations is likely mediated through its
      effect on physical activity. The current proposal aims to derive preliminary data to support
      a large pragmatic trial testing the impact of interventions geared towards improving physical
      activity and function in KOA patients.

      Promoting physical activity has been shown to be helpful in reducing pain and improving
      function in KOA and other groups. However, promoting behavioral change in the arthritis
      population is a significant challenge. The group has shown that social incentives [and
      gamification] derived from concepts from the field of behavioral economics to promote
      behavioral change and increase physical activity can be both practical and effective in other
      settings. The investigators' group is studying incentives in patients with inflammatory
      arthritis with the goal of addressing fatigue, pain, and deficits in physical function. The
      incentivization of physical activity using this approach represents a novel intervention for
      the managing symptoms of KOA and to improving overall health.

      Analgesic therapies can help KOA patients participate in exercise therapy. However, whether
      corticosteroid injections, a commonly used medical therapy for KOA pain, has a positive
      impact of physical activity is unknown and is an additional important question addressed by
      the current proposal. Despite widespread use, definitive data demonstrating a consistent
      benefit of corticosteroids are lacking. A large randomized trial recently tested the effects
      of repeated corticosteroids injections every 3 months for a period of 2 years on patient
      reported pain as well as progression of disease measured by magnetic resonance imaging (MRI).
      This study demonstrated no improvement in pain compared to saline injections. In addition, a
      small but statistically significant decline in cartilage thickness on MRI was observed,
      raising a concern for side effects. These recent data might suggest that corticosteroid
      injections result in more harm than good, and may discourage providers from performing this
      intervention. However, there are critical weaknesses to this study. Pain and function were
      only assessed at 3-month intervals, while previous trials have suggested that peak benefit is
      expected at 4-8 weeks. Moreover, the clinical and biologic significance decrease in cartilage
      thickness is unclear.

      The investigators propose to fill these important knowledge gaps with an innovative and
      efficient pragmatic clinical trial with a factorial and crossover design. A large and
      definitive practical trial would lead to better understanding of the clinical effectiveness
      of these interventions, the meaningfulness of their combined impact, and the subgroups that
      are most likely to derive benefit. This clinical trial of 32-40 patients will leverage unique
      resources available through the Penn Center for Innovation to better capture important
      patient-reported outcomes in real-time through a web-based platform. The study will also test
      the feasibility of a crossover and factorial design to improve efficiency and reduce
      confounding. Each patient will receive each intervention (saline, corticosteroids) in random
      order over 1 year. A factorial design will be employed and will randomize participants to
      receive social incentives with gamification to promote increases in their physical activity.
      To accomplish these aims, the investigators will utilize innovative mobile applications for
      smart phones and wearable activity trackers through the Way-to-Health platform and assess, in
      real time, the impact of the intervention on patient-reported function and pain as well as
      physical activity. The technology will allow for the recording of outcomes as they occur,
      between clinic visits, thereby avoiding information bias due to poor recall. It will also
      provide real-time assessment of symptoms, providing granular assessments of response over
      time. The investigative team includes early career investigators with experience conducting
      similar trials using this infrastructure. Results will provide preliminary data to power a
      large, feasible, and low-cost pragmatic multi-site trial that would lead to practical
      implementation. The specific aims of the study are:

      Aim 1: To determine the feasibility of recruitment and retention of Veterans with
      osteoarthritis of the knee (KOA) in a practical trial using an innovative online trial
      platform incorporating mobile activity monitors. The investigators expect to recruit and
      retain 32 Veterans within 1 year.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Participants are randomized with a software application to receive social incentives to promote physical activity. They will also be randomized to receive corticosteroid injections in a crossover design.
primary purpose: Treatment
masking: Single (Participant)
masking description: It is not possible to blind participants to the social incentives they will receive. For the injection aspect of the study, the investigator will be aware of the injection being given but the syringe will be covered to obscure the view of the patient.
measure: Percent change from baseline in weekly average steps per day
time frame: Measured weekly over 3-10 months
description: Steps measured by a wearable activity monitor
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Measured bi-weekly over 3-10 months
description: KOOS assessed by survey at 2 week intervals. KOOS scores range from 0 to 100 with 0 representing worse knee problems and 100 representing no knee problems.
measure: Change in PROMIS pain intensity score
time frame: Measured bi-weekly over 3-10 months
description: Assessed by survey at 2 week intervals. Scores range from 3-15 and are converted to T-Scores. A high score represents greater pain.
measure: Change in PROMIS Fatigue
time frame: Measured every 4 weeks over 3-10 months
description: Assessed by survey at 4 week intervals
arm group label: Social Incentives and Gamification, Corticosteroid AB
arm group type: Experimental
description: Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals.
The participants will receive injections in A-B order (corticosteroids, then lidocaine only)
arm group label: No Incentive, Corticosteroid AB
arm group type: Active Comparator
description: Participants will only receive reminders to sync their activity monitor.
The participants will receive injections in A-B order (corticosteroids, then lidocaine only)
arm group label: Social Incentives and Gamification, Corticosteroid BA
arm group type: Experimental
description: Participants will receive a support person and be able to interact with a web-based platform to progress through levels based on their achievement of step goals.
The participants will receive injections in B-A order (lidocaine only, then corticosteroids)
arm group label: No Incentive, Corticosteroid BA
arm group type: Active Comparator
description: Participants will only receive reminders to sync their activity monitor.
The participants will receive injections in B-A order (lidocaine only, then corticosteroids)
intervention type: Behavioral
intervention name: Social Incentives and Gamification to Promote Exercise
description: The intervention will provide social incentives and gamification to promote physical activity.
arm group label: Social Incentives and Gamification, Corticosteroid AB
arm group label: Social Incentives and Gamification, Corticosteroid BA
intervention type: Procedure
intervention name: Corticosteroid Injection given in A-B order
description: The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.
arm group label: No Incentive, Corticosteroid AB
arm group label: Social Incentives and Gamification, Corticosteroid AB
intervention type: Behavioral
intervention name: No Social Incentive applied
description: No social incentive will be applied
arm group label: No Incentive, Corticosteroid AB
arm group label: No Incentive, Corticosteroid BA
intervention type: Procedure
intervention name: Corticosteroid Injection given in B-A order
description: The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.
arm group label: No Incentive, Corticosteroid BA
arm group label: Social Incentives and Gamification, Corticosteroid BA
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joshua F. Baker, MD MSCE
role: Principal Investigator
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
provided document: 
submitted: June 2, 2022
returned: March 14, 2023
submitted: March 14, 2023