<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/NCT03300375</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701256</org_study_id>
    <secondary_id>OCR18330</secondary_id>
    <nct_id>NCT03300375</nct_id>
  </id_info>
  <brief_title>Exercise Intervention for Unilateral Amputees With Low Back Pain</brief_title>
  <official_title>Exercise Intervention for Unilateral Amputees With Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      A three-month, randomized, controlled study will be used to examine the effects of a&#xD;
      home-based resistance exercise program on improving pain severity and functional ability in&#xD;
      unilateral lower extremity amputees who suffer from Low Back Pain. The study will follow the&#xD;
      principles of the Consolidated Standards of Reporting Trials for randomized, two group,&#xD;
      parallel studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Amputation to the lower extremity is a life-changing event. Approximately 2 million Americans&#xD;
      live with limb loss, with ~45% of losses occurring from traumatic mechanisms. After the&#xD;
      injury has healed and a prosthetic limb is fitted, the long-term care for amputees typically&#xD;
      focuses on maintenance of the prosthesis fit and optimizing physical function. Even with&#xD;
      high-quality prostheses, amputation permanently impacts biomechanical symmetry of gait. After&#xD;
      unilateral transtibial or transfemoral amputation, skeletal muscle atrophy occurs in the&#xD;
      lower extremity and back. Asymmetric gait causes mechanical stresses at lumbar spine, and&#xD;
      loss of muscle mass and strength, all of which exaggerate gait aberrations. As a result,&#xD;
      chronic low back pain (LBP) can develop. LBP is a common, but often unaddressed, secondary&#xD;
      complication in over half of the unilateral amputee population.&#xD;
&#xD;
      Lower extremity amputees face numerous physical and emotional challenges after their&#xD;
      injuries. Performing ambulatory activities are more physically demanding with an amputation&#xD;
      than without. The psychological stress levels are often high after an amputation,&#xD;
      contributing to activity avoidance and limiting participation in load-bearing activities. LBP&#xD;
      independently contributes to costly health burdens such as addiction to pain medicine,&#xD;
      depression and lifestyle diseases and LBP erodes physical and mental quality of life (QOL).&#xD;
      Pain is also related to skeletal muscle atrophy in the low back. The combination of an&#xD;
      amputation injury and LBP may amplify ambulation-related limitations and further deteriorate&#xD;
      QOL. Unilateral lower extremity amputees who suffer from chronic LBP therefore may therefore&#xD;
      experience greater walking limitations, physical activity avoidance and physiological changes&#xD;
      to skeletal muscle, strength and perceived QOL than people with back pain or amputation&#xD;
      alone.&#xD;
&#xD;
      Long-term care for amputees requires a team of physicians, prostheticians, therapists and&#xD;
      other specialists. Patients often travel long distances to receive their care. Patients with&#xD;
      limited resources may not be able to maintain a long-term relationship with therapists due to&#xD;
      cost restrictions. Home-based interventions that target LBP could substantially impact the&#xD;
      secondary disease burden and help restore QOL in the amputee population. In the general&#xD;
      population, evidence indicates that consistently-performed muscle strengthening activity is&#xD;
      associated with significantly lower odds of developing back pain in men and women. Resistance&#xD;
      exercise is effective for lumbar muscle strength gains, functional gains in ambulation and&#xD;
      movement and for improving both physical and mental aspects of QOL. Resistance training&#xD;
      benefits in strength, motor skills, and many aspects of quality of life (both functional and&#xD;
      psychosocial) are seen throughout several different demographics; from young adults to the&#xD;
      elderly.&#xD;
&#xD;
      Current clinical paradigms to treat general LBP include referral to physical therapy for&#xD;
      strengthening exercise programs. For amputees, challenges to receiving therapeutic care&#xD;
      include travel distance, and financial limitations for exercise facility memberships or&#xD;
      therapy copayments. Patients may not be able to sustain and therapy gains over the long-term&#xD;
      when therapy benefits run out. Thus, exercise to treat LBP in amputees must be accessible,&#xD;
      low or no cost and sustainable. A significant deficit in the clinical literature is that the&#xD;
      study team does not know the effectiveness of home-based resistance training on different&#xD;
      chronic musculoskeletal pains in amputees. Moreover, the mechanisms that may contribute to&#xD;
      effectiveness of strength training on pain relief in amputees are not clear. The problem is&#xD;
      therefore multifaceted: 1) amputees experience permanent anatomic changes that impact&#xD;
      load-bearing activity, back pain and QOL; 2) chronic LBP treatment is not often a focus for&#xD;
      the long-term management of the unilateral lower extremity amputee; 3) chronic LBP can&#xD;
      develop in amputees as a consequence of asymmetric movement patterns, lumbar muscle atrophy&#xD;
      and low muscle strength, but the relative contribution of each to pain severity is not known.&#xD;
      These evidence gaps are significant barriers to the optimization of care for this special&#xD;
      population by clinical teams who care for these individuals, and for determination of pain&#xD;
      responders with strengthening exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</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>
    <intervention_model_description>Two group, parallel study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Permuted block randomization with block sizes of four will made by means of a computer algorithm to ensure balanced group sizes and allocation concealment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Pain and Catastrophizing Scale (PCS) is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional impairment due to back pain</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Roland Disability Questionnaire consist of 24 items (see below). Those 24 questions are related specifically to physical functions that were likely to be affected by low back pain. Greater levels of disability are reflected by higher numbers. Scores under 4 and over 20 may not show significant change over time in patients with scores of less than 4 and deterioration in patients who have scores greater than 20.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Medical Outcomes Short-Form 36 (SF-36) This instrument has 36 items and yields eight domain scores and two component scores (Mental, Physical). The eight domains are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and emotional well-being. The SF-36 has shown good internal consistency (Cronbach's range of 0.95-0.93). This instrument has been used to track QOL after traumatic injury, such as amputation.50</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional disability in patients with low back pain</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Oswestry Disability Questionnaire: 0-20% Minimal disability; 20-40% Moderate disability; 40-60% Severe disability; 60-80% Crippled; 80-100% bed-bound.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Home-Based Resistance Exercise Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the HBRX group will be coached through six phases of the intervention with two weeks per phase. Exercise will use body weight and resistance exercise bands. A set of commercial elastic resistive bands and a stability pad (TheraBand, Inc.) will be provided to each participant to keep for personal use after their participation in the study. The use of elastic bands for resistance training can induce similar results in neuromuscular adaptations as well as strength to those achieved by weight machines and free-weights.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List Control Condition Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are assigned to the CON group will wait to participate in the resistance training after a three month wait period. Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time. The participants will be contacted by phone on a monthly basis during the study period to determine if any changes in LBP symptoms have occurred. At month three, these participants will also receive the elastic resistive bands and a stability pad.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise program</intervention_name>
    <description>Home-based, progressive exercise program using resistance bands</description>
    <arm_group_label>Home-Based Resistance Exercise Intervention Group</arm_group_label>
    <arm_group_label>Wait-List Control Condition Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post Op instructions</intervention_name>
    <description>Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.</description>
    <arm_group_label>Wait-List Control Condition Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18-60 years of age&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Suffering from chronic LBP (&gt;3 months with ≥3 pain episodes per week)&#xD;
&#xD;
          -  Baseline pain of ≥3 points out of 10 on the NRSPain scale&#xD;
&#xD;
          -  Amputation ≥1 year prior and their current prosthesis must have been worn for at least&#xD;
             6 months (prosthesis K-Level of K2 or greater, indicating the subject is able to&#xD;
             ambulate and traverse low-level environmental barriers such as curbs, stairs, or&#xD;
             uneven surfaces).&#xD;
&#xD;
          -  Must have regular access to a computer for skype, or a mobile phone or iPAD to perform&#xD;
             facetime&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute back injury&#xD;
&#xD;
          -  Any other chronic back pathology (i.e. herniated disc, ankylosing spondylosis, other&#xD;
             related neurologic disease)&#xD;
&#xD;
          -  Pain symptoms or functional limitations (including those that may require assistive&#xD;
             devices) that preclude participation in resistance exercise or physical activity&#xD;
&#xD;
          -  Back surgery within the past two years that restrict daily physical activities&#xD;
&#xD;
          -  Currently enrolled in any other resistance or strengthening exercise interventions&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Vincent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Undecided</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/NCT03300375
org study id: IRB201701256
secondary id: OCR18330
nct id: NCT03300375
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A three-month, randomized, controlled study will be used to examine the effects of a
      home-based resistance exercise program on improving pain severity and functional ability in
      unilateral lower extremity amputees who suffer from Low Back Pain. The study will follow the
      principles of the Consolidated Standards of Reporting Trials for randomized, two group,
      parallel studies.
Amputation to the lower extremity is a life-changing event. Approximately 2 million Americans
      live with limb loss, with ~45% of losses occurring from traumatic mechanisms. After the
      injury has healed and a prosthetic limb is fitted, the long-term care for amputees typically
      focuses on maintenance of the prosthesis fit and optimizing physical function. Even with
      high-quality prostheses, amputation permanently impacts biomechanical symmetry of gait. After
      unilateral transtibial or transfemoral amputation, skeletal muscle atrophy occurs in the
      lower extremity and back. Asymmetric gait causes mechanical stresses at lumbar spine, and
      loss of muscle mass and strength, all of which exaggerate gait aberrations. As a result,
      chronic low back pain (LBP) can develop. LBP is a common, but often unaddressed, secondary
      complication in over half of the unilateral amputee population.

      Lower extremity amputees face numerous physical and emotional challenges after their
      injuries. Performing ambulatory activities are more physically demanding with an amputation
      than without. The psychological stress levels are often high after an amputation,
      contributing to activity avoidance and limiting participation in load-bearing activities. LBP
      independently contributes to costly health burdens such as addiction to pain medicine,
      depression and lifestyle diseases and LBP erodes physical and mental quality of life (QOL).
      Pain is also related to skeletal muscle atrophy in the low back. The combination of an
      amputation injury and LBP may amplify ambulation-related limitations and further deteriorate
      QOL. Unilateral lower extremity amputees who suffer from chronic LBP therefore may therefore
      experience greater walking limitations, physical activity avoidance and physiological changes
      to skeletal muscle, strength and perceived QOL than people with back pain or amputation
      alone.

      Long-term care for amputees requires a team of physicians, prostheticians, therapists and
      other specialists. Patients often travel long distances to receive their care. Patients with
      limited resources may not be able to maintain a long-term relationship with therapists due to
      cost restrictions. Home-based interventions that target LBP could substantially impact the
      secondary disease burden and help restore QOL in the amputee population. In the general
      population, evidence indicates that consistently-performed muscle strengthening activity is
      associated with significantly lower odds of developing back pain in men and women. Resistance
      exercise is effective for lumbar muscle strength gains, functional gains in ambulation and
      movement and for improving both physical and mental aspects of QOL. Resistance training
      benefits in strength, motor skills, and many aspects of quality of life (both functional and
      psychosocial) are seen throughout several different demographics; from young adults to the
      elderly.

      Current clinical paradigms to treat general LBP include referral to physical therapy for
      strengthening exercise programs. For amputees, challenges to receiving therapeutic care
      include travel distance, and financial limitations for exercise facility memberships or
      therapy copayments. Patients may not be able to sustain and therapy gains over the long-term
      when therapy benefits run out. Thus, exercise to treat LBP in amputees must be accessible,
      low or no cost and sustainable. A significant deficit in the clinical literature is that the
      study team does not know the effectiveness of home-based resistance training on different
      chronic musculoskeletal pains in amputees. Moreover, the mechanisms that may contribute to
      effectiveness of strength training on pain relief in amputees are not clear. The problem is
      therefore multifaceted: 1) amputees experience permanent anatomic changes that impact
      load-bearing activity, back pain and QOL; 2) chronic LBP treatment is not often a focus for
      the long-term management of the unilateral lower extremity amputee; 3) chronic LBP can
      develop in amputees as a consequence of asymmetric movement patterns, lumbar muscle atrophy
      and low muscle strength, but the relative contribution of each to pain severity is not known.
      These evidence gaps are significant barriers to the optimization of care for this special
      population by clinical teams who care for these individuals, and for determination of pain
      responders with strengthening exercise.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two group, parallel study
primary purpose: Treatment
masking: Single (Participant)
masking description: Permuted block randomization with block sizes of four will made by means of a computer algorithm to ensure balanced group sizes and allocation concealment.
measure: Pain assessment
time frame: Up to 6 months
description: Pain and Catastrophizing Scale (PCS) is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations.
measure: Functional impairment due to back pain
time frame: Up to 6 months
description: Roland Disability Questionnaire consist of 24 items (see below). Those 24 questions are related specifically to physical functions that were likely to be affected by low back pain. Greater levels of disability are reflected by higher numbers. Scores under 4 and over 20 may not show significant change over time in patients with scores of less than 4 and deterioration in patients who have scores greater than 20.
measure: Quality of Life Assessment
time frame: Up to 6 months
description: Medical Outcomes Short-Form 36 (SF-36) This instrument has 36 items and yields eight domain scores and two component scores (Mental, Physical). The eight domains are: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and emotional well-being. The SF-36 has shown good internal consistency (Cronbach's range of 0.95-0.93). This instrument has been used to track QOL after traumatic injury, such as amputation.50
measure: Functional disability in patients with low back pain
time frame: up to 6 months
description: Oswestry Disability Questionnaire: 0-20% Minimal disability; 20-40% Moderate disability; 40-60% Severe disability; 60-80% Crippled; 80-100% bed-bound.
arm group label: Home-Based Resistance Exercise Intervention Group
arm group type: Active Comparator
description: Participants in the HBRX group will be coached through six phases of the intervention with two weeks per phase. Exercise will use body weight and resistance exercise bands. A set of commercial elastic resistive bands and a stability pad (TheraBand, Inc.) will be provided to each participant to keep for personal use after their participation in the study. The use of elastic bands for resistance training can induce similar results in neuromuscular adaptations as well as strength to those achieved by weight machines and free-weights.
arm group label: Wait-List Control Condition Group
arm group type: Experimental
description: Participants who are assigned to the CON group will wait to participate in the resistance training after a three month wait period. Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time. The participants will be contacted by phone on a monthly basis during the study period to determine if any changes in LBP symptoms have occurred. At month three, these participants will also receive the elastic resistive bands and a stability pad.
intervention type: Other
intervention name: Home exercise program
description: Home-based, progressive exercise program using resistance bands
arm group label: Home-Based Resistance Exercise Intervention Group
arm group label: Wait-List Control Condition Group
intervention type: Other
intervention name: Post Op instructions
description: Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.
arm group label: Wait-List Control Condition Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Heather Vincent, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided