<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/NCT02241824</url>
  </required_header>
  <id_info>
    <org_study_id>MIRB# 1273</org_study_id>
    <nct_id>NCT02241824</nct_id>
  </id_info>
  <brief_title>Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention</brief_title>
  <official_title>Chronic Opioid Use in Low Back Pain and Lumbar Orthosis Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geoffrey C. Garth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Long Beach Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Aspen Medical Products</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale&#xD;
&#xD;
        -  Statement of the Problem. Low back pain is a significant societal problem in the United&#xD;
           States, affecting approximately one-fourth of all Americans at any given time.&#xD;
           Non-pharmacological therapies have not been well studied although preliminary evidence&#xD;
           shows the utilization of bracing may be beneficial in reducing pain and medication&#xD;
           usage.&#xD;
&#xD;
        -  Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic&#xD;
           lumbar brace may decrease opioid use in chronic low back pain patients on a stable&#xD;
           opioid regimen. The investigators propose to conduct a randomized controlled study to&#xD;
           test our hypothesis.&#xD;
&#xD;
        -  Specific Objectives.&#xD;
&#xD;
      AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable&#xD;
      opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace,&#xD;
      elastic abdominal binder (standard care), and no brace (control).&#xD;
&#xD;
      AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life,&#xD;
      and functional capacity.&#xD;
&#xD;
      Long Term aims: To decrease patient's chronic pain level, improve overall daily function,&#xD;
      decrease overall opioid intake and improve quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Significance&#xD;
&#xD;
      Low back pain (LBP) is a common problem in our society with potential for significant&#xD;
      morbidity and mortality. One of the treatments for LBP, opioid therapy, has been increasingly&#xD;
      utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The&#xD;
      long term use of opioids carries its own risk for adverse events and risk of addiction.3&#xD;
      Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology&#xD;
      of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid&#xD;
      therapy, our attention needs to be drawn to find more affordable alternatives.&#xD;
&#xD;
      Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid&#xD;
      use in the chronic low back pain population. The specific aims of this project are to perform&#xD;
      a pilot study to assess the feasibility of this project and plan for a larger randomized&#xD;
      controlled trial. Additional long-term goals of this study are to assess the effect of an&#xD;
      inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in&#xD;
      opioid use and subsequent control or reduction of pain. Secondary endpoints will note&#xD;
      improvement in functional outcomes and other quality of life measures. The findings of this&#xD;
      preliminary study conducted at the VA facility will provide data to perform a large&#xD;
      multi-center randomized controlled trial and prepare for a NIH proposal to study other&#xD;
      benefits of inelastic lumbar bracing.&#xD;
&#xD;
      (3) Work Accomplished&#xD;
&#xD;
      (a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions&#xD;
      Following Pilot Studies: Sponsored new study&#xD;
&#xD;
      (4) Work Proposed This trial will be a prospective randomized three armed trial of an&#xD;
      in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no&#xD;
      brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid&#xD;
      medications with follow-up monitoring up to 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brace fitting and assessment</measure>
    <time_frame>Initial visit (month 1 of 12)</time_frame>
    <description>Visit 1: Screening &amp; randomization Study parameters and informed consent will be explained and given to potential participants. If interested, study staff will confirm eligibility and randomize the patient into a group. Patient demographics, medical history and surgical history will be obtained as well as basic vitals. A study team member will then perform the physical function exam, administer the pain assessment, and record current opioid use. Patients will then be fitted for a brace (for those with a brace) and instructed to wear the brace all day, every day except when sleeping or showering. Patients will then be given the packet of quality of life questionnaires and ODI surveys and given ample time to fill them out. Before leaving, patients will schedule the next two phone call checkups and the 3 month visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain and opioid reduction</measure>
    <time_frame>Visit 2: (month 3 of 12)</time_frame>
    <description>Visit 2 (3 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion, degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). Prior to leaving the patient will schedule monthly telephone contacts for the next 8 months as well as their last physical visit at the 12 month time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain and opioid reduction</measure>
    <time_frame>Visit 3 (month 12 of 12)</time_frame>
    <description>Visit 3 (12 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion (active and passive), degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). All patients will be notified that they can keep their brace, if they were given one for the study and that they have completed the study.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Chronic Lower Back Pain</condition>
  <condition>Chronic Opioid Use</condition>
  <arm_group>
    <arm_group_label>Elastic abdominal binder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an elastic abdominal binder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No brace</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen with no brace (control).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-elastic lumbar brace</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an in-elastic lumbar brace.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>In-elastic lumbar brace</intervention_name>
    <arm_group_label>In-elastic lumbar brace</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elastic abdominal binder</intervention_name>
    <arm_group_label>Elastic abdominal binder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must satisfy diagnostic criteria for lumbar back pain&#xD;
&#xD;
          -  Evidence of lumbar back pain base upon one or more of the following:&#xD;
&#xD;
               -  Lumbar back pain episodes lasting greater than 3 months&#xD;
&#xD;
               -  Has received treatment for recurring nonspecific low back pain&#xD;
&#xD;
               -  Treatment with 3-6 months of stable opioid use.&#xD;
&#xD;
          -  Men or women age greater than or equal to 20 years&#xD;
&#xD;
          -  Fluency in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment risk factors including one or more of the following:&#xD;
&#xD;
               -  Unstable or symptomatic cardiac complaints&#xD;
&#xD;
               -  Unstable or symptomatic respiratory complaints&#xD;
&#xD;
               -  Unable to reliably comprehend the protocol or reliably record data&#xD;
&#xD;
          -  Pregnancy. A serum pregnancy test must be performed and negative in all women of child&#xD;
             bearing potential within 2 weeks prior to enrollment.&#xD;
&#xD;
          -  Any medical or psychosocial condition that, in the opinion of the investigator, could&#xD;
             jeopardize the subject's participation, and compliance with the study criteria.&#xD;
&#xD;
          -  No significant alcohol use (7 or fewer drinks per week).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eric Y Chang, MD</last_name>
    <phone>(714) 598-1745</phone>
    <email>eric.chang6@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Long Beach VA</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sophia Chun, MD</last_name>
      <phone>562-826-5701</phone>
      <email>sophia.chun@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>May 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>July 7, 2015</last_update_submitted>
  <last_update_submitted_qc>July 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aspen Medical Products</investigator_affiliation>
    <investigator_full_name>Geoffrey C. Garth</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Lumbar Orthosis</keyword>
  <keyword>Lumbar brace</keyword>
  <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>
  <!-- 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/NCT02241824
org study id: MIRB# 1273
nct id: NCT02241824
lead sponsor: 
collaborator: 
has dmc: Yes
Rationale

        -  Statement of the Problem. Low back pain is a significant societal problem in the United
           States, affecting approximately one-fourth of all Americans at any given time.
           Non-pharmacological therapies have not been well studied although preliminary evidence
           shows the utilization of bracing may be beneficial in reducing pain and medication
           usage.

        -  Hypotheses or Key Question. The investigators hypothesize that the use of an inelastic
           lumbar brace may decrease opioid use in chronic low back pain patients on a stable
           opioid regimen. The investigators propose to conduct a randomized controlled study to
           test our hypothesis.

        -  Specific Objectives.

      AIM 1: To evaluate the opioid consumption in chronic low back pain patients on a stable
      opioid regimen in a three armed trial, after an intervention of an in-elastic lumbar brace,
      elastic abdominal binder (standard care), and no brace (control).

      AIM 2: To evaluate changes in secondary endpoints such as pain intensity, quality of life,
      and functional capacity.

      Long Term aims: To decrease patient's chronic pain level, improve overall daily function,
      decrease overall opioid intake and improve quality of life.
Background and Significance

      Low back pain (LBP) is a common problem in our society with potential for significant
      morbidity and mortality. One of the treatments for LBP, opioid therapy, has been increasingly
      utilized for noncancerous pain,1 and has a 4.2% prevalence in the United States alone.2 The
      long term use of opioids carries its own risk for adverse events and risk of addiction.3
      Thus, with the lack of evidence based research for treatments of LBP, the rising epidemiology
      of LBP in the US, the rise in cost of medical care, along with the potential risks of opioid
      therapy, our attention needs to be drawn to find more affordable alternatives.

      Our study proposes to evaluate whether an inelastic lumbar brace will reduce chronic opioid
      use in the chronic low back pain population. The specific aims of this project are to perform
      a pilot study to assess the feasibility of this project and plan for a larger randomized
      controlled trial. Additional long-term goals of this study are to assess the effect of an
      inelastic lumbar brace in a chronic LBP population, and if there is a significant decrease in
      opioid use and subsequent control or reduction of pain. Secondary endpoints will note
      improvement in functional outcomes and other quality of life measures. The findings of this
      preliminary study conducted at the VA facility will provide data to perform a large
      multi-center randomized controlled trial and prepare for a NIH proposal to study other
      benefits of inelastic lumbar bracing.

      (3) Work Accomplished

      (a) New submissions: Preliminary studies have not been conducted yet. (b) Submissions
      Following Pilot Studies: Sponsored new study

      (4) Work Proposed This trial will be a prospective randomized three armed trial of an
      in-elastic lumbar brace group (BG), elastic abdominal binder (EG), and a control group [no
      brace] (CG) in the treatment of chronic low back pain patients are prescribed chronic opioid
      medications with follow-up monitoring up to 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Brace fitting and assessment
time frame: Initial visit (month 1 of 12)
description: Visit 1: Screening & randomization Study parameters and informed consent will be explained and given to potential participants. If interested, study staff will confirm eligibility and randomize the patient into a group. Patient demographics, medical history and surgical history will be obtained as well as basic vitals. A study team member will then perform the physical function exam, administer the pain assessment, and record current opioid use. Patients will then be fitted for a brace (for those with a brace) and instructed to wear the brace all day, every day except when sleeping or showering. Patients will then be given the packet of quality of life questionnaires and ODI surveys and given ample time to fill them out. Before leaving, patients will schedule the next two phone call checkups and the 3 month visit.
measure: Pain and opioid reduction
time frame: Visit 2: (month 3 of 12)
description: Visit 2 (3 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion, degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). Prior to leaving the patient will schedule monthly telephone contacts for the next 8 months as well as their last physical visit at the 12 month time point.
measure: Pain and opioid reduction
time frame: Visit 3 (month 12 of 12)
description: Visit 3 (12 month visit) When the patient arrives for their appointment, they will leave all bracing in the car so that the physician is blinded when recording information. A study team member will take vitals, review any changes in medication or adverse events and then perform a physical exam documenting range of motion (active and passive), degree of tender points, and hamstring tightness. The study team member will also record the patients brace wearing compliance, pain assessment and perform a pill count for opioid consumption. The patient will then be asked to fill out the ODI and other quality of life surveys (SF-12 and MPI). All patients will be notified that they can keep their brace, if they were given one for the study and that they have completed the study.
arm group label: Elastic abdominal binder
arm group type: Active Comparator
description: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an elastic abdominal binder.
arm group label: No brace
arm group type: No Intervention
description: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen with no brace (control).
arm group label: In-elastic lumbar brace
arm group type: Experimental
description: To evaluate the opioid consumption in chronic low back pain patients on a stable opioid regimen after an intervention of an in-elastic lumbar brace.
intervention type: Device
intervention name: In-elastic lumbar brace
arm group label: In-elastic lumbar brace
intervention type: Device
intervention name: Elastic abdominal binder
arm group label: Elastic abdominal binder
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 72 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Y Chang, MD
phone: (714) 598-1745
email: eric.chang6@va.gov
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Aspen Medical Products
investigator full name: Geoffrey C. Garth
investigator title: Investigator
mesh term: Back Pain
mesh term: Low Back Pain