<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/NCT03031158</url>
  </required_header>
  <id_info>
    <org_study_id>943328</org_study_id>
    <nct_id>NCT03031158</nct_id>
  </id_info>
  <brief_title>Hip-spine Intervention for Older Adults With Chronic Low Back Pain</brief_title>
  <official_title>Pilot Trial of a Hip-spine Intervention for Older Adults With a Primary Complaint of Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Delaware</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Delaware</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low back pain (LBP) is extremely common in older adults and is associated with a host of&#xD;
      negative consequences, including decreased physical function and increased healthcare&#xD;
      utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are&#xD;
      more prevalent and associated with greater disability than among older adults without LBP.&#xD;
      This study will investigate a novel intervention designed to improve LBP-related disability&#xD;
      by combining a typical spine-focused exercise program with a hip-focused intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">March 13, 2018</completion_date>
  <primary_completion_date type="Actual">March 13, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quebec Low Back Pain Disability Scale</measure>
    <time_frame>Change in disability score from pre-intervention to 20 weeks later</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Specific Functional Scale</measure>
    <time_frame>Change in pain-related function score from pre-intervention to 20 weeks later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Walking Endurance as measured by the 6 minute walk test</measure>
    <time_frame>Change in walking endurance from pre-intervention to 20 weeks later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking speed</measure>
    <time_frame>Change in walking endurance from pre-intervention to 20 weeks later</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>SFEX+H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SFEX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SFEX+H</intervention_name>
    <description>Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.</description>
    <arm_group_label>SFEX+H</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SFEX</intervention_name>
    <description>Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.</description>
    <arm_group_label>SFEX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 60-85&#xD;
&#xD;
          2. Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or&#xD;
             almost every day that requires activity modification.&#xD;
&#xD;
          3. Presence of at least 1 hip impairment denoted by the American College of Rheumatology&#xD;
             as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation&#xD;
             or morning stiffness of the hip of &lt;60 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous hip fracture repair or total hip replacement&#xD;
&#xD;
          2. Prominent component of radicular pain: CLBP with distal radiation below the knee&#xD;
&#xD;
          3. Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or&#xD;
             recent trauma, spinal stenosis, vertebral compression fractures, ankylosing&#xD;
             spondylitis, carcinoma metastatic to the spine)&#xD;
&#xD;
          4. Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair)&#xD;
&#xD;
          5. Folstein Mini-Mental State Examination score of &lt;24&#xD;
&#xD;
          6. Severe visual or hearing impairment.&#xD;
&#xD;
          7. Red flags indicative of a serious disorder underlying the LBP: Red flags that would&#xD;
             require specialized medical attention include fever, significant unintentional weight&#xD;
             loss, a sudden recent change in the character or intensity of pain, trauma that&#xD;
             preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of&#xD;
             sensation over saddle region, significant disturbances in bowel and bladder function).&#xD;
&#xD;
          8. Significant pain in parts of the body other than the back or acute LBP.&#xD;
&#xD;
          9. Acute, ongoing illness.&#xD;
&#xD;
         10. Inability to participate in the study for the full six months for any known&#xD;
             reason.(i.e. moving away, extended vacation)&#xD;
&#xD;
         11. Received physical therapy for their LBP within in the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Delaware</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Delaware</investigator_affiliation>
    <investigator_full_name>Gregory Evan Hicks</investigator_full_name>
    <investigator_title>Associate Professor</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/NCT03031158
org study id: 943328
nct id: NCT03031158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low back pain (LBP) is extremely common in older adults and is associated with a host of
      negative consequences, including decreased physical function and increased healthcare
      utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are
      more prevalent and associated with greater disability than among older adults without LBP.
      This study will investigate a novel intervention designed to improve LBP-related disability
      by combining a typical spine-focused exercise program with a hip-focused intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Quebec Low Back Pain Disability Scale
time frame: Change in disability score from pre-intervention to 20 weeks later
measure: Patient-Specific Functional Scale
time frame: Change in pain-related function score from pre-intervention to 20 weeks later
measure: Walking Endurance as measured by the 6 minute walk test
time frame: Change in walking endurance from pre-intervention to 20 weeks later
measure: Walking speed
time frame: Change in walking endurance from pre-intervention to 20 weeks later
arm group label: SFEX+H
arm group type: Experimental
description: Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles.
arm group label: SFEX
arm group type: Active Comparator
description: Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles.
intervention type: Behavioral
intervention name: SFEX+H
description: Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.
arm group label: SFEX+H
intervention type: Behavioral
intervention name: SFEX
description: Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.
arm group label: SFEX
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Delaware
investigator full name: Gregory Evan Hicks
investigator title: Associate Professor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No