<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/NCT04401683</url>
  </required_header>
  <id_info>
    <org_study_id>SH-RCT-LBP-01</org_study_id>
    <nct_id>NCT04401683</nct_id>
  </id_info>
  <brief_title>Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Chronic Low Back Pain</brief_title>
  <official_title>Home-based Exercise Rehabilitation With a Novel Digital Biofeedback System for Non-specific Chronic Low Back Pain: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sword Health, SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Hospitalar e Universitário do Porto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sword Health, SA</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 present study is a a single-center, prospective, non-blind, parallel-group, randomized&#xD;
      controlled trial, designed to evaluate the clinical impact of a home-based program using a&#xD;
      new digital solution on the treatment of non-specific chronic low back pain (CLBP) in adults&#xD;
      versus standard of care.&#xD;
&#xD;
      The hypothesis is that all the clinical outcomes measured will significantly improve after&#xD;
      the program, and patients using this novel system will attain better outcomes than the ones&#xD;
      in the standard of care group.&#xD;
&#xD;
      This evidence-based digital program developed by SWORD Health is built on three main pillars&#xD;
      - therapeutic exercise, education and cognitive-behavioural therapy, and is specifically&#xD;
      tailored to address CLBP. The program will be delivered directly at patient's home, using a&#xD;
      biofeedback system and continuous personalised remote clinical monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) has for long been the world's leading cause of years leaved with&#xD;
      disability, and, considering that the overall life expectancy is rising, this pandemic only&#xD;
      tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of&#xD;
      lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work&#xD;
      absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare&#xD;
      between different countries, its overwhelming socio-economic impact in modern society is&#xD;
      evident.&#xD;
&#xD;
      In the absence of an effective treatment, LBP can become chronic, causing a huge impact in&#xD;
      patients' daily life, and ultimately promoting a high consumption of healthcare resources. In&#xD;
      the US alone, health expenditures for adults with spinal problems were estimated at $6000 per&#xD;
      person, representing a total cost of $102 billion each year.&#xD;
&#xD;
      The dim picture described above highlights the urgent need for effective interventions that&#xD;
      minimize disability, improve quality of life and decrease productivity losses.&#xD;
&#xD;
      Current guidelines on CLBP management recommend patient education, exercise, physical&#xD;
      therapy, and behavioural therapy as the mainstays treatments for this condition. Despite some&#xD;
      discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back&#xD;
      schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually&#xD;
      designed programs, supervised home exercise, and group exercise), exercise therapy is&#xD;
      recommended nearly transversally, with most studies concluding that exercise intervention&#xD;
      programs should include a combination of muscular strength, flexibility and aerobic fitness&#xD;
      exercises. Moreover, home exercises with a regular therapist follow-up has proven highly&#xD;
      effective. Importantly, however, the main driver of the direct cost component in the care of&#xD;
      LBP is physical therapy, meaning new ways of delivering therapy are warranted.&#xD;
&#xD;
      Besides exercise therapy, opioid prescription is also a common practice, despite known&#xD;
      opioid-related morbidity and mortality rates. Because the prevalence of CLBP is continuously&#xD;
      rising, and opioid misuse is an issue of great concern globally, identifying effective&#xD;
      non-opioid alternatives for CLBP is of paramount importance.&#xD;
&#xD;
      Thus, SWORD Health has developed an evidence-based program for this disorder based on two&#xD;
      main pillars - patient education and therapeutic exercise - the latter delivered through our&#xD;
      digital therapist, directly at the patient´s home, and with continuous clinical supervision.&#xD;
&#xD;
      This approach has already demonstrated to be feasible, safe and to lead to better outcomes&#xD;
      than conventional home-based rehabilitation after joint replacement. These results were&#xD;
      explained by (a) the positive impact of a kinematic biofeedback tool on patient performance,&#xD;
      especially regarding error correction and stimulation of a greater range of motion; (b)&#xD;
      patient empowerment regarding their rehabilitation process; (c) high patient engagement&#xD;
      through the use of gamification strategies; (d) the positive effect of remote monitoring on&#xD;
      patient effort and (e) the availability of objective data for clinical review, enabling&#xD;
      data-driven decisions.&#xD;
&#xD;
      The present study is a a single-center, prospective, non-blind, parallel-group, randomized&#xD;
      controlled trial, designed to evaluate the clinical impact of a home-based program using a&#xD;
      new digital solution on the treatment of non-specific CLBP in adults versus standard of care.&#xD;
      The hypothesis is that all the clinical outcomes measured will significantly improve after&#xD;
      the program, and patients using this novel system will attain better outcomes than the ones&#xD;
      in the standard of care group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">May 25, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Oswestry Disability Index (ODI) score</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program</time_frame>
    <description>The ODI is a condition-specific self-reported measure, that aims to assess the level of disability in different physical activities in patients with low back pain. Scoring: 10 items, each with 6 possible answers (scored from 0 to 5 points) and a total score ranging from 0-100, being 100 the worst function/disability possible. The total score of ODI is calculated through te total sum of the section scores, divided by the total possible score and the result is then multiplied by 100, to achieve a percentage score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fear-Avoidance Beliefs Questionnaire (FABQ)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program</time_frame>
    <description>Assesses fear-avoidance beliefs regarding physical activity and work in low back pain patients. It is composed by a total of 15 items, each with a 7 option Likert scale. Those with a lower score are less likely to comply with an exercise program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program</time_frame>
    <description>Pain catastrophizing is highly correlated with pain and disability in individuals with chronic low back pain and is considered one predictor of low back pain with disability. 13-item questionnaire regarding individuals thoughts and feelings about pain, with 3 subscales: rumination, magnification and helplessness. Higher scores indicate higher pain catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Numeric Rating Scale (NRS) score</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program</time_frame>
    <description>Unidimensional 11 point measure of pain, in which the patients are asked to classify their pain from 0 (no pain) to 10 (worst imaginable pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Non-specific Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Digital Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard medical treatment + Fully remote rehabilitation program with a digital therapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard medical treatment + Home-based rehabilitation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home-based rehabilitation with a digital biofeedback system</intervention_name>
    <description>Participants in the experimental group will perform a 12-week digital exercise program, to be performed independently at home using the SWORD Phoenix® medical device, under remote monitoring from a physical therapist.&#xD;
Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.</description>
    <arm_group_label>Digital Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional home-based rehabilitation</intervention_name>
    <description>Participants in the control group will benefit from a 12-week home-based rehabilitation program, consisting of 12 face-to-face sessions (1 per week) with a physical therapist, complemented by additional non-supervised sessions. Both supervised and unsupervised sessions will follow the same set of exercises defined for the experimental group.&#xD;
Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.</description>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged between 18 and 70 years&#xD;
&#xD;
          2. Intermittent or persistent low back pain for at least 3 months and on at least half&#xD;
             the days in the previous 6 months without peripheral symptoms&#xD;
&#xD;
          3. Ability to understand motor complex commands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breast-feeding&#xD;
&#xD;
          2. Inability to stand upright&#xD;
&#xD;
          3. Clear indication for surgery or other medical treatment (e.g. cancer, infection, cauda&#xD;
             equina syndrome, significant lumbar disc herniation or rupture, nerve compression)&#xD;
&#xD;
          4. Acute low back pain in the past 7 days or unilateral or bilateral radicular pain&#xD;
&#xD;
          5. Neurologic condition (e.g. stroke, multiple sclerosis, Parkinson's disease)&#xD;
&#xD;
          6. Concomitant treatment for LBP&#xD;
&#xD;
          7. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light&#xD;
             to moderate physical activity&#xD;
&#xD;
          8. Severe reduction of visual and/or auditory acuity, aphasia, dementia or psychiatric&#xD;
             comorbidity significantly interfering with communication or compliance to a home-based&#xD;
             exercise program&#xD;
&#xD;
          9. Osteoarticular condition (e.g. fractures or severe osteoarthrosis) that prevents the&#xD;
             patient from complying with a home-based exercise program&#xD;
&#xD;
         10. Other medical complications that prevent the patient from complying with a home-based&#xD;
             exercise program&#xD;
&#xD;
         11. Illiteracy&#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>Sérgio Moreira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Hospitalar e Universitário do Porto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário do Porto - Largo Prof Abel Salazar</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</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>Yes</sharing_ipd>
    <ipd_description>The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Upon study publication, for at least five years.</ipd_time_frame>
    <ipd_access_criteria>Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.</ipd_access_criteria>
  </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/NCT04401683
org study id: SH-RCT-LBP-01
nct id: NCT04401683
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study is a a single-center, prospective, non-blind, parallel-group, randomized
      controlled trial, designed to evaluate the clinical impact of a home-based program using a
      new digital solution on the treatment of non-specific chronic low back pain (CLBP) in adults
      versus standard of care.

      The hypothesis is that all the clinical outcomes measured will significantly improve after
      the program, and patients using this novel system will attain better outcomes than the ones
      in the standard of care group.

      This evidence-based digital program developed by SWORD Health is built on three main pillars
      - therapeutic exercise, education and cognitive-behavioural therapy, and is specifically
      tailored to address CLBP. The program will be delivered directly at patient's home, using a
      biofeedback system and continuous personalised remote clinical monitoring.
Low back pain (LBP) has for long been the world's leading cause of years leaved with
      disability, and, considering that the overall life expectancy is rising, this pandemic only
      tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of
      lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work
      absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare
      between different countries, its overwhelming socio-economic impact in modern society is
      evident.

      In the absence of an effective treatment, LBP can become chronic, causing a huge impact in
      patients' daily life, and ultimately promoting a high consumption of healthcare resources. In
      the US alone, health expenditures for adults with spinal problems were estimated at $6000 per
      person, representing a total cost of $102 billion each year.

      The dim picture described above highlights the urgent need for effective interventions that
      minimize disability, improve quality of life and decrease productivity losses.

      Current guidelines on CLBP management recommend patient education, exercise, physical
      therapy, and behavioural therapy as the mainstays treatments for this condition. Despite some
      discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back
      schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually
      designed programs, supervised home exercise, and group exercise), exercise therapy is
      recommended nearly transversally, with most studies concluding that exercise intervention
      programs should include a combination of muscular strength, flexibility and aerobic fitness
      exercises. Moreover, home exercises with a regular therapist follow-up has proven highly
      effective. Importantly, however, the main driver of the direct cost component in the care of
      LBP is physical therapy, meaning new ways of delivering therapy are warranted.

      Besides exercise therapy, opioid prescription is also a common practice, despite known
      opioid-related morbidity and mortality rates. Because the prevalence of CLBP is continuously
      rising, and opioid misuse is an issue of great concern globally, identifying effective
      non-opioid alternatives for CLBP is of paramount importance.

      Thus, SWORD Health has developed an evidence-based program for this disorder based on two
      main pillars - patient education and therapeutic exercise - the latter delivered through our
      digital therapist, directly at the patient´s home, and with continuous clinical supervision.

      This approach has already demonstrated to be feasible, safe and to lead to better outcomes
      than conventional home-based rehabilitation after joint replacement. These results were
      explained by (a) the positive impact of a kinematic biofeedback tool on patient performance,
      especially regarding error correction and stimulation of a greater range of motion; (b)
      patient empowerment regarding their rehabilitation process; (c) high patient engagement
      through the use of gamification strategies; (d) the positive effect of remote monitoring on
      patient effort and (e) the availability of objective data for clinical review, enabling
      data-driven decisions.

      The present study is a a single-center, prospective, non-blind, parallel-group, randomized
      controlled trial, designed to evaluate the clinical impact of a home-based program using a
      new digital solution on the treatment of non-specific CLBP in adults versus standard of care.
      The hypothesis is that all the clinical outcomes measured will significantly improve after
      the program, and patients using this novel system will attain better outcomes than the ones
      in the standard of care group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Oswestry Disability Index (ODI) score
time frame: Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program
description: The ODI is a condition-specific self-reported measure, that aims to assess the level of disability in different physical activities in patients with low back pain. Scoring: 10 items, each with 6 possible answers (scored from 0 to 5 points) and a total score ranging from 0-100, being 100 the worst function/disability possible. The total score of ODI is calculated through te total sum of the section scores, divided by the total possible score and the result is then multiplied by 100, to achieve a percentage score.
measure: Change in Fear-Avoidance Beliefs Questionnaire (FABQ)
time frame: Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program
description: Assesses fear-avoidance beliefs regarding physical activity and work in low back pain patients. It is composed by a total of 15 items, each with a 7 option Likert scale. Those with a lower score are less likely to comply with an exercise program.
measure: Change in Pain Catastrophizing Scale (PCS)
time frame: Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program
description: Pain catastrophizing is highly correlated with pain and disability in individuals with chronic low back pain and is considered one predictor of low back pain with disability. 13-item questionnaire regarding individuals thoughts and feelings about pain, with 3 subscales: rumination, magnification and helplessness. Higher scores indicate higher pain catastrophizing.
measure: Change in Numeric Rating Scale (NRS) score
time frame: Baseline, 6 weeks and 12 weeks after initiation of rehabilitation program
description: Unidimensional 11 point measure of pain, in which the patients are asked to classify their pain from 0 (no pain) to 10 (worst imaginable pain).
arm group label: Digital Rehabilitation
arm group type: Experimental
description: Standard medical treatment + Fully remote rehabilitation program with a digital therapist
arm group label: Conventional Rehabilitation
arm group type: Active Comparator
description: Standard medical treatment + Home-based rehabilitation program
intervention type: Device
intervention name: Home-based rehabilitation with a digital biofeedback system
description: Participants in the experimental group will perform a 12-week digital exercise program, to be performed independently at home using the SWORD Phoenix® medical device, under remote monitoring from a physical therapist.
Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.
arm group label: Digital Rehabilitation
intervention type: Other
intervention name: Conventional home-based rehabilitation
description: Participants in the control group will benefit from a 12-week home-based rehabilitation program, consisting of 12 face-to-face sessions (1 per week) with a physical therapist, complemented by additional non-supervised sessions. Both supervised and unsupervised sessions will follow the same set of exercises defined for the experimental group.
Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises.
arm group label: Conventional Rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sérgio Moreira, MD
role: Principal Investigator
affiliation: Centro Hospitalar e Universitário do Porto
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Upon study publication, for at least five years.
ipd access criteria: Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.