<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/NCT04494490</url>
  </required_header>
  <id_info>
    <org_study_id>NMCSD.2018.0034</org_study_id>
    <nct_id>NCT04494490</nct_id>
  </id_info>
  <brief_title>Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial</brief_title>
  <acronym>RESOLVE</acronym>
  <official_title>Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Naval Health Research Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>James A. Haley Veterans Administration Hospital</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA New York Harbor Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marine Corps Base Camp Pendleton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>United States Naval Medical Center, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy&#xD;
      Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare&#xD;
      utilization for low back pain within the Departments of Defense and Veterans Affairs&#xD;
      healthcare systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the&#xD;
      U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT&#xD;
      practice patterns and utilization of ineffective interventions lower the quality and increase&#xD;
      the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve&#xD;
      outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The&#xD;
      RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy&#xD;
      using an education/audit/feedback model for reducing pain, disability, medication use and&#xD;
      cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include&#xD;
      3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge&#xD;
      study design. An education/audit/feedback model will be used to encourage the physical&#xD;
      therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability&#xD;
      and pain intensity will be measured with the Oswestry Disability Index and the Defense and&#xD;
      Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource&#xD;
      utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based&#xD;
      on intention to treat principles and will use linear mixed models to compare treatment&#xD;
      conditions, and examine the interactions between treatment and sub-grouping status. The&#xD;
      RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can&#xD;
      reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA&#xD;
      healthcare systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>Every two weeks over course of PT treatment, up to 12 weeks</time_frame>
    <description>Change in Defense and Veterans Pain Rating Scale (DVPRS) score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability</measure>
    <time_frame>Every two weeks over course of PT treatment, up to 12 weeks</time_frame>
    <description>Change in Oswestry Disability Index (ODI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>One year</time_frame>
    <description>Change in frequency of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>One year</time_frame>
    <description>Change in extent of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Medication Use</measure>
    <time_frame>One year</time_frame>
    <description>Change in frequency of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Medication Use</measure>
    <time_frame>One year</time_frame>
    <description>Change in extent of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">7260</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Usual Care Condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the usual care condition the therapists will be instructed &quot;to act as usual,&quot; that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPG+PIPT Condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback</intervention_name>
    <description>The aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders.</description>
    <arm_group_label>CPG+PIPT Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Receiving physical therapy care for low back pain in an outpatient physical therapy&#xD;
             setting&#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_contact>
    <last_name>Shawn Farrokhi, PT, PhD</last_name>
    <phone>619-532-8582</phone>
    <email>shawn.farrokhi.civ@health.mil</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Gorczynski, PT, DPT</last_name>
    <phone>619-532-9704</phone>
    <email>sara.r.gorczynski.ctr@health.mil</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United States Naval Medical Center, San Diego</investigator_affiliation>
    <investigator_full_name>Shawn Farrokhi, PT, PhD</investigator_full_name>
    <investigator_title>Facility Research Director, DoD-VA Extremity Trauma and Amputation Center of Excellence (EACE)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT04494490
org study id: NMCSD.2018.0034
nct id: NCT04494490
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy
      Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare
      utilization for low back pain within the Departments of Defense and Veterans Affairs
      healthcare systems.
Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the
      U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT
      practice patterns and utilization of ineffective interventions lower the quality and increase
      the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve
      outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The
      RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy
      using an education/audit/feedback model for reducing pain, disability, medication use and
      cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include
      3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge
      study design. An education/audit/feedback model will be used to encourage the physical
      therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability
      and pain intensity will be measured with the Oswestry Disability Index and the Defense and
      Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource
      utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based
      on intention to treat principles and will use linear mixed models to compare treatment
      conditions, and examine the interactions between treatment and sub-grouping status. The
      RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can
      reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA
      healthcare systems.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pain Intensity
time frame: Every two weeks over course of PT treatment, up to 12 weeks
description: Change in Defense and Veterans Pain Rating Scale (DVPRS) score
measure: Disability
time frame: Every two weeks over course of PT treatment, up to 12 weeks
description: Change in Oswestry Disability Index (ODI)
measure: Healthcare Utilization
time frame: One year
description: Change in frequency of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).
measure: Healthcare Utilization
time frame: One year
description: Change in extent of healthcare utilization:The medical resources of interest for this trial will include: 1) referrals to specialists (e.g., orthopedists, spine surgeons, physiatrists) and other health care providers, and 2) tests (e.g., x-rays, MRIs), surgical procedures (e.g., epidural steroid injections, laminectomy).
measure: Analgesic Medication Use
time frame: One year
description: Change in frequency of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).
measure: Analgesic Medication Use
time frame: One year
description: Change in extent of analgesic medication use: prescribing patterns for key drug classes commonly used for low back pain management such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (Tylenol), opioid analgesics, skeletal muscle relaxants, antidepressants (e.g., tricyclic antidepressants and duloxetine), and drugs for neuropathic pain (e.g., gabapentin).
arm group label: Usual Care Condition
arm group type: No Intervention
description: During the usual care condition the therapists will be instructed "to act as usual," that is, to read the guidelines on low back pain if they have read previous published guidelines and not read these guidelines if they have not read any other guidelines.
arm group label: CPG+PIPT Condition
arm group type: Active Comparator
description: An active Clinical Practice Guidelines (CPG) implementation strategy will be utilized with an education component in Psychologically Informed Physical Therapy (PIPT) with peer opinion leaders and a monthly audit/feedback on CPG adherence rates and patient outcomes
intervention type: Behavioral
intervention name: Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback
description: The aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders.
arm group label: CPG+PIPT Condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shawn Farrokhi, PT, PhD
phone: 619-532-8582
email: shawn.farrokhi.civ@health.mil
last name: Sara Gorczynski, PT, DPT
phone: 619-532-9704
email: sara.r.gorczynski.ctr@health.mil
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: United States Naval Medical Center, San Diego
investigator full name: Shawn Farrokhi, PT, PhD
investigator title: Facility Research Director, DoD-VA Extremity Trauma and Amputation Center of Excellence (EACE)
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No