<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/NCT03297905</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004220</org_study_id>
    <nct_id>NCT03297905</nct_id>
  </id_info>
  <brief_title>Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury</brief_title>
  <official_title>Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Madigan Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will (1) compare the effectiveness of standard rehabilitative pain care with&#xD;
      complementary and integrative pain therapies; (2) identify subgroups of patients who do and&#xD;
      do not respond to the intervention(s); (3) determine the most effective sequencing of the&#xD;
      interventions; and (4) determine factors associated with treatment response that can be&#xD;
      implemented to support clinical decision-making.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of&#xD;
      disability among active duty military Service members. The injury rate is significant with&#xD;
      628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service&#xD;
      members. Neuromusculoskeletal injuries include amputations following battlefield trauma,&#xD;
      repetitive motion injuries related to equipment use or weight-bearing postures, and even&#xD;
      injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on&#xD;
      both individual Service members and military readiness are significant: Only 13% of Service&#xD;
      members being treated primarily for pain ever return to the field.&#xD;
&#xD;
      The Department of Defense (DoD) has recently expanded its capacity to provide both functional&#xD;
      restoration (FR) and complementary and integrative medicine (CIM) therapies for&#xD;
      neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine&#xD;
      the most effective treatment combination, sequence, and duration of standard rehabilitative&#xD;
      care (SRC), such as physical and occupational therapy in combination with cognitive&#xD;
      behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service&#xD;
      members preparing to enroll in an intensive FR program that is currently the DoD-recommended&#xD;
      treatment. In addition, this study aims to identify ways to predict in advance which patients&#xD;
      will respond best to which therapeutic regimens.&#xD;
&#xD;
      Potential Impact. This research has the potential to determine which patients are most likely&#xD;
      to benefit from the non-medication pain therapies currently available in all Army&#xD;
      Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively&#xD;
      be combined to achieve the greatest improvements in pain impact, quality of life and ability&#xD;
      to return to duty following injury.&#xD;
&#xD;
      Patients Who Will Benefit. This study will involve active duty Service members referred to an&#xD;
      Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans&#xD;
      Health Administration (VHA) pain management centers so that active duty Service members and&#xD;
      veterans across United States may benefit from a treatment approach that is tailored to their&#xD;
      individual characteristics. It is anticipated that the knowledge gained through this research&#xD;
      will be applicable to family members of Service members and veterans and will ultimately lead&#xD;
      to expansion of TRICARE benefits to include CIM therapies.&#xD;
&#xD;
      Potential Clinical Applications, Benefits, and Risks. This research will assist providers in&#xD;
      determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM&#xD;
      therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the&#xD;
      needs of each patient. Service members and veterans will benefit by being referred for these&#xD;
      approaches when appropriate during the course of disabling chronic pain conditions.&#xD;
      Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record&#xD;
      to guide health care providers to consider referral for these therapies in patients who may&#xD;
      benefit. This study will advance our ability to effectively tailor therapies for&#xD;
      rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest&#xD;
      benefit in physical function and quality of life. The risks of these interventions are&#xD;
      minimal; Service members may experience general muscle soreness for the first week or so of&#xD;
      increased physical activity, but this typically resolves.&#xD;
&#xD;
      Projected Timeline. This research will determine the optimal combination, sequence, and&#xD;
      duration of therapies. It is expected that some active duty Service members could see&#xD;
      improvements in function and quality of life within three weeks, but others may require up to&#xD;
      six weeks to experience meaningful improvement.&#xD;
&#xD;
      Benefit to Military Personnel. This research will benefit Service members experiencing pain&#xD;
      due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies&#xD;
      most likely to yield meaningful improvements in function and quality of life, and thus&#xD;
      facilitate their return to duty. The recommendations from this study will be shared with pain&#xD;
      management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 15, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 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>
    <intervention_model_description>Sequential Multiple Assignment Randomized Trial (SMART)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Pain Intensity</measure>
    <time_frame>3 months</time_frame>
    <description>Pain Intensity 10-pt Numeric Rating Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Pain Impact</measure>
    <time_frame>3 months</time_frame>
    <description>Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotional Distress - Anger</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Patient Reported Outcome Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Primary Care PTSD Screen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Use</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Drug Use Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Pain Catastrophizing Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinesiophobia</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Tampa Scale for Kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Self-Efficacy</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Pain Self Efficacy Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Pain Acceptance</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Chronic Pain Acceptance Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Capacity</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Utilization</measure>
    <time_frame>baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months</time_frame>
    <description>Opioid Utilization Screener</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cortisol</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Salivary Cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative Stress</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Urine Sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genomic DNA</measure>
    <time_frame>baseline</time_frame>
    <description>Buccal Sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Army Physical Fitness Test (APFT)</measure>
    <time_frame>baseline, 6 weeks, 3 months, 6 months</time_frame>
    <description>Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as &quot;force-readiness&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Complementary and Integrative Therapies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Rehabilitative Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Complementary and Integrative Therapies</intervention_name>
    <description>Intervention time period is 3 - 6 weeks.</description>
    <arm_group_label>Complementary and Integrative Therapies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Rehabilitative Care</intervention_name>
    <description>Intervention time period is 3 - 6 weeks.</description>
    <arm_group_label>Standard Rehabilitative Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty service members&#xD;
&#xD;
          -  Neuromusculoskeletal or neuropathic pain ≥ 3-months duration&#xD;
&#xD;
          -  Pain of sufficient severity to bring about dysfunction in daily social, vocational,&#xD;
             and/or interpersonal activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major surgeries within past 6 months or planned within next 6 months&#xD;
&#xD;
          -  Unstable psychological disorders&#xD;
&#xD;
          -  Active substance use disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ardith Z Doorenbos, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Ardith Doorenbos</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>Military</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT03297905
org study id: STUDY00004220
nct id: NCT03297905
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will (1) compare the effectiveness of standard rehabilitative pain care with
      complementary and integrative pain therapies; (2) identify subgroups of patients who do and
      do not respond to the intervention(s); (3) determine the most effective sequencing of the
      interventions; and (4) determine factors associated with treatment response that can be
      implemented to support clinical decision-making.
Objectives and Rationale. Pain due to neuromusculoskeletal injuries is a leading cause of
      disability among active duty military Service members. The injury rate is significant with
      628 neuromusculoskeletal injuries per 1000 person-years among active duty military Service
      members. Neuromusculoskeletal injuries include amputations following battlefield trauma,
      repetitive motion injuries related to equipment use or weight-bearing postures, and even
      injuries or strains incurred during off-duty pursuits. Regardless of cause, the effects on
      both individual Service members and military readiness are significant: Only 13% of Service
      members being treated primarily for pain ever return to the field.

      The Department of Defense (DoD) has recently expanded its capacity to provide both functional
      restoration (FR) and complementary and integrative medicine (CIM) therapies for
      neuromusculoskeletal injury, pain, and disability. The proposed research aims to determine
      the most effective treatment combination, sequence, and duration of standard rehabilitative
      care (SRC), such as physical and occupational therapy in combination with cognitive
      behavioral therapy and CIM therapies, such as acupuncture and chiropractic, for Service
      members preparing to enroll in an intensive FR program that is currently the DoD-recommended
      treatment. In addition, this study aims to identify ways to predict in advance which patients
      will respond best to which therapeutic regimens.

      Potential Impact. This research has the potential to determine which patients are most likely
      to benefit from the non-medication pain therapies currently available in all Army
      Interdisciplinary Pain Management Centers (IPMC) and how these therapies can most effectively
      be combined to achieve the greatest improvements in pain impact, quality of life and ability
      to return to duty following injury.

      Patients Who Will Benefit. This study will involve active duty Service members referred to an
      Army IPMC. The results will be shared with other Military Health System (MHS) and Veterans
      Health Administration (VHA) pain management centers so that active duty Service members and
      veterans across United States may benefit from a treatment approach that is tailored to their
      individual characteristics. It is anticipated that the knowledge gained through this research
      will be applicable to family members of Service members and veterans and will ultimately lead
      to expansion of TRICARE benefits to include CIM therapies.

      Potential Clinical Applications, Benefits, and Risks. This research will assist providers in
      determining when to refer their patients with neuromusculoskeletal pain for SRC and/or CIM
      therapies prior to FR. It will assist IPMCs in developing treatment plans tailored to the
      needs of each patient. Service members and veterans will benefit by being referred for these
      approaches when appropriate during the course of disabling chronic pain conditions.
      Ultimately, it is hoped that decision tools can be imbedded in the electronic medical record
      to guide health care providers to consider referral for these therapies in patients who may
      benefit. This study will advance our ability to effectively tailor therapies for
      rehabilitation from neuromusculoskeletal pain for different patients to yield the greatest
      benefit in physical function and quality of life. The risks of these interventions are
      minimal; Service members may experience general muscle soreness for the first week or so of
      increased physical activity, but this typically resolves.

      Projected Timeline. This research will determine the optimal combination, sequence, and
      duration of therapies. It is expected that some active duty Service members could see
      improvements in function and quality of life within three weeks, but others may require up to
      six weeks to experience meaningful improvement.

      Benefit to Military Personnel. This research will benefit Service members experiencing pain
      due to neuromusculoskeletal injury. It will identify ways to direct them to the therapies
      most likely to yield meaningful improvements in function and quality of life, and thus
      facilitate their return to duty. The recommendations from this study will be shared with pain
      management centers throughout the DoD, VHA; and, we hope, eventually to TRICARE members.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Sequential Multiple Assignment Randomized Trial (SMART)
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Pain Intensity
time frame: 3 months
description: Pain Intensity 10-pt Numeric Rating Scale
measure: Change from Baseline Pain Impact
time frame: 3 months
description: Aggregate score calculated from Defense and Veterans Pain Rating Scale (DVPRS)
measure: Depression
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Patient Reported Outcome Measurement Information System
measure: Anxiety
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Patient Reported Outcome Measurement Information System
measure: Emotional Distress - Anger
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Patient Reported Outcome Measurement Information System
measure: Sleep Disturbance
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Patient Reported Outcome Measurement Information System
measure: Fatigue
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Patient Reported Outcome Measurement Information System
measure: PTSD
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Primary Care PTSD Screen
measure: Patient Activation Measure
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: A 22-item survey that addresses four stages of patient activation: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. Patients are asked to agree or not to agree with each of the 22 items.
measure: Drug Use
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Drug Use Questionnaire
measure: Pain Catastrophizing
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Pain Catastrophizing Scale
measure: Kinesiophobia
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Tampa Scale for Kinesiophobia
measure: Pain Self-Efficacy
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Pain Self Efficacy Questionnaire
measure: Chronic Pain Acceptance
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Chronic Pain Acceptance Questionnaire
measure: Functional Capacity
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Roland-Morris Disability Questionnaire and Canadian Occupational Performance Measure
measure: Opioid Utilization
time frame: baseline, 3 weeks, 6 weeks, 9 weeks, 3 months, 6 months
description: Opioid Utilization Screener
measure: Cortisol
time frame: baseline, 6 weeks
description: Salivary Cortisol
measure: Oxidative Stress
time frame: baseline, 6 weeks
description: Urine Sample
measure: Genomic DNA
time frame: baseline
description: Buccal Sample
measure: Army Physical Fitness Test (APFT)
time frame: baseline, 6 weeks, 3 months, 6 months
description: Passing scores of 60 on all 3 components (push-ups, sit-ups, 2-mile run) of the APFT will be operationalized as "force-readiness".
arm group label: Complementary and Integrative Therapies
arm group type: Experimental
description: Chiropractic, Acupuncture, Yoga, Biofeedback (if indicated), and Foam roller instruction
arm group label: Standard Rehabilitative Care
arm group type: Active Comparator
description: Cognitive Behavioral Therapy (CBT) 60-minute orientation, CBT psychoeducation group, and Physical therapy/occupational therapy
intervention type: Behavioral
intervention name: Complementary and Integrative Therapies
description: Intervention time period is 3 - 6 weeks.
arm group label: Complementary and Integrative Therapies
intervention type: Behavioral
intervention name: Standard Rehabilitative Care
description: Intervention time period is 3 - 6 weeks.
arm group label: Standard Rehabilitative Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ardith Z Doorenbos, RN, PhD
role: Principal Investigator
affiliation: University of Washington
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Ardith Doorenbos
investigator title: Professor
mesh term: Chronic Pain