xml: <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/NCT05998434</url>
    </required_header>
    <id_info>
      <org_study_id>[2023]102</org_study_id>
      <nct_id>NCT05998434</nct_id>
    </id_info>
    <brief_title>Home-Based Rehabilitation Training for Chronic Low Back Pain Patients</brief_title>
    <official_title>Home-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital, Sun Yat-Sen University</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 goal of this clinical trial is to test the effectiveness of a new digital therapy for&#xD;
        managing chronic low back pain in adults. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does the digital therapy improve back function and reduce pain intensity in participants&#xD;
             with chronic low back pain?&#xD;
  &#xD;
          -  How does the digital therapy's impact compare to traditional exercise therapy?&#xD;
  &#xD;
        Participants in this study will be asked to use the digital therapy app on their smartphones.&#xD;
        They will receive guided core stability exercises through the app and will be encouraged to&#xD;
        perform these exercises at home. Researchers will assess participants' progress by monitoring&#xD;
        their exercise adherence and tracking changes in their back function and pain intensity over&#xD;
        time.&#xD;
  &#xD;
        To compare the effects of the digital therapy, some participants will follow a traditional&#xD;
        exercise therapy program guided by a physical therapist. Researchers will compare the&#xD;
        outcomes of these two groups to determine whether the digital therapy is as effective as&#xD;
        traditional therapy in improving back function and reducing pain intensity in individuals&#xD;
        with chronic low back pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This detailed description provides an extended overview of the protocol for the clinical&#xD;
        trial focused on testing the efficacy of a digital therapy for managing chronic low back&#xD;
        pain. The trial seeks to compare the digital therapy's impact against traditional exercise&#xD;
        therapy in individuals with chronic low back pain.&#xD;
  &#xD;
        Participants and Procedures:&#xD;
  &#xD;
        Participants will be recruited based on specific eligibility criteria, including age, medical&#xD;
        history, and duration of chronic low back pain. After obtaining informed consent,&#xD;
        participants will be randomly assigned to one of two groups: the digital therapy group or the&#xD;
        traditional exercise therapy group.&#xD;
  &#xD;
        Digital Therapy Group:&#xD;
  &#xD;
        Participants in this group will receive access to a digital therapy app on their smartphones.&#xD;
        The app will guide them through core stability exercises, providing step-by-step instructions&#xD;
        and visual demonstrations. Participants will be encouraged to perform these exercises&#xD;
        regularly at home. Researchers will monitor participants' exercise adherence and collect data&#xD;
        on their back function and pain intensity over the study period.&#xD;
  &#xD;
        Traditional Exercise Therapy Group:&#xD;
  &#xD;
        Participants in this group will receive traditional exercise therapy guided by a physical&#xD;
        therapist. They will attend in-person sessions at a designated clinic, where they will&#xD;
        receive personalized exercise recommendations and instructions. Similar to the digital&#xD;
        therapy group, researchers will monitor exercise adherence and track changes in back function&#xD;
        and pain intensity.&#xD;
  &#xD;
        Quality Assurance and Data Management:&#xD;
  &#xD;
        The study will implement a comprehensive quality assurance plan to ensure the accuracy and&#xD;
        reliability of collected data. This plan will include data validation procedures, site&#xD;
        monitoring, and auditing. Data checks will be conducted to identify inconsistencies or errors&#xD;
        in the collected data. Source data verification will be employed to cross-reference registry&#xD;
        data with external sources, such as medical records.&#xD;
  &#xD;
        Data Dictionary and Standard Operating Procedures:&#xD;
  &#xD;
        A data dictionary will be developed, detailing each variable used in the registry. This will&#xD;
        include the source of the variable, coding information, and normal ranges if relevant.&#xD;
        Standard Operating Procedures (SOPs) will be established to govern registry operations and&#xD;
        analysis activities, covering patient recruitment, data collection, data management,&#xD;
        analysis, adverse event reporting, and change management.&#xD;
  &#xD;
        Sample Size and Missing Data:&#xD;
  &#xD;
        A sample size assessment will be conducted to determine the number of participants or&#xD;
        participant years required to demonstrate a statistically significant effect. A plan for&#xD;
        handling missing data will be devised to address situations where variables are missing or&#xD;
        inconsistent due to various reasons.&#xD;
  &#xD;
        Statistical Analysis Plan:&#xD;
  &#xD;
        A detailed statistical analysis plan will be developed, outlining the analytical principles&#xD;
        and statistical techniques to address primary and secondary objectives outlined in the study&#xD;
        protocol or plan. This will guide the analysis of data collected throughout the trial.&#xD;
  &#xD;
        In summary, this comprehensive protocol describes the structure, procedures, and quality&#xD;
        measures of a clinical trial comparing the effectiveness of a digital therapy and traditional&#xD;
        exercise therapy in managing chronic low back pain. The implementation of rigorous quality&#xD;
        assurance procedures and data management strategies will ensure the reliability and validity&#xD;
        of the study's findings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2025</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>11-point numeric rating scale（NRS）</measure>
      <time_frame>baseline，4 weeks and 16 weeks</time_frame>
      <description>NRS;0=no pain, 10=unbearable pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the Oswestry Disability Index (ODI)</measure>
      <time_frame>baseline，4 weeks and 16 weeks</time_frame>
      <description>The ODI evaluated disability across 10 domains, encompassing pain intensity and functional abilities related to personal care, lifting, walking, sitting, standing, sleeping, sexual activities, social life, and traveling. Each domain was rated on a 6-point scale ranging from 0 to 5. A score of 0 indicated the highest level of functioning, while a score of 50 indicated total disability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The 36-item Short Form Health Survey (SF-36)</measure>
      <time_frame>baseline，4 weeks and 16 weeks</time_frame>
      <description>it evaluates an individual's physical, mental, and social health experiences across eight domains, including Physical Functioning, Mental Health, and more. With 36 questions, responses are scored from 0 to 100, reflecting higher scores for better health status. Its brevity, versatility, and comprehensive health dimension coverage are notable advantages. The SF-36 finds applications in clinical practice, epidemiology, and health outcome studies, aiding in diagnosis, treatment, and policy decisions.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Chronic Low Back Pain</condition>
    <arm_group>
      <arm_group_label>the digital therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants randomly assigned to the intervention group will receive home-based exercise training with human key-point detection.They will be instructed to complete a minimum of three sports training sessions per week at their preferred time and location.The exercise prescription will be formulated based on previous comprehensive studies, encompassing exercises targeting strength, balance, flexibility, and mobility.Human key point detection technology accurately estimates 25 key points of the human body in pictures or videos using visual detection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>traditional exercise therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The participants randomly assigned to the control group will receive traditional face-to-face exercise instruction. An experienced therapist( 10 years of experience) will be arranged to provide the subjects with 20-30 minutes of exercise instruction three times a week for four weeks. The training sessions were scheduled to start at 4 p.m. on Monday, Wednesday, and Friday of each week. The exercise training content selected for the control group will be consistent with that of the intervention group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Improving Low Back Pain Through Motor Control Training</intervention_name>
      <description>In the digital healthcare group, participants utilized app-based online motor control training. In contrast, participants in the traditional treatment group underwent motor control training under the guidance of healthcare professionals at the hospital.</description>
      <arm_group_label>the digital therapy</arm_group_label>
      <arm_group_label>traditional exercise therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age between 18 and 60 years;&#xD;
  &#xD;
            2. Duration of low back pain of at least 12 weeks;&#xD;
  &#xD;
            3. Strong willingness to participate in the study and signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Presence of potential &quot;red flag signs&quot; (e.g., unilateral leg pain and numbness&#xD;
               consistent with nerve distribution, intermittent claudication, unexplained sudden&#xD;
               weight loss, nocturnal lumbar pain, traumatic lumbago);&#xD;
  &#xD;
            2. NRS score less than 4 points;&#xD;
  &#xD;
            3. Regular engagement in core stability training in the past four weeks;&#xD;
  &#xD;
            4. Inability to independently complete the Chinese electronic questionnaire.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Fuming Zheng</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Human Key-Point Detection</keyword>
    <keyword>Core Stability Exercise</keyword>
    <keyword>digital healthcare</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998434
  org study id: [2023]102
  nct id: NCT05998434
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effectiveness of a new digital therapy for
        managing chronic low back pain in adults. The main questions it aims to answer are:
  
          -  Does the digital therapy improve back function and reduce pain intensity in participants
             with chronic low back pain?
  
          -  How does the digital therapy's impact compare to traditional exercise therapy?
  
        Participants in this study will be asked to use the digital therapy app on their smartphones.
        They will receive guided core stability exercises through the app and will be encouraged to
        perform these exercises at home. Researchers will assess participants' progress by monitoring
        their exercise adherence and tracking changes in their back function and pain intensity over
        time.
  
        To compare the effects of the digital therapy, some participants will follow a traditional
        exercise therapy program guided by a physical therapist. Researchers will compare the
        outcomes of these two groups to determine whether the digital therapy is as effective as
        traditional therapy in improving back function and reducing pain intensity in individuals
        with chronic low back pain.
  This detailed description provides an extended overview of the protocol for the clinical
        trial focused on testing the efficacy of a digital therapy for managing chronic low back
        pain. The trial seeks to compare the digital therapy's impact against traditional exercise
        therapy in individuals with chronic low back pain.
  
        Participants and Procedures:
  
        Participants will be recruited based on specific eligibility criteria, including age, medical
        history, and duration of chronic low back pain. After obtaining informed consent,
        participants will be randomly assigned to one of two groups: the digital therapy group or the
        traditional exercise therapy group.
  
        Digital Therapy Group:
  
        Participants in this group will receive access to a digital therapy app on their smartphones.
        The app will guide them through core stability exercises, providing step-by-step instructions
        and visual demonstrations. Participants will be encouraged to perform these exercises
        regularly at home. Researchers will monitor participants' exercise adherence and collect data
        on their back function and pain intensity over the study period.
  
        Traditional Exercise Therapy Group:
  
        Participants in this group will receive traditional exercise therapy guided by a physical
        therapist. They will attend in-person sessions at a designated clinic, where they will
        receive personalized exercise recommendations and instructions. Similar to the digital
        therapy group, researchers will monitor exercise adherence and track changes in back function
        and pain intensity.
  
        Quality Assurance and Data Management:
  
        The study will implement a comprehensive quality assurance plan to ensure the accuracy and
        reliability of collected data. This plan will include data validation procedures, site
        monitoring, and auditing. Data checks will be conducted to identify inconsistencies or errors
        in the collected data. Source data verification will be employed to cross-reference registry
        data with external sources, such as medical records.
  
        Data Dictionary and Standard Operating Procedures:
  
        A data dictionary will be developed, detailing each variable used in the registry. This will
        include the source of the variable, coding information, and normal ranges if relevant.
        Standard Operating Procedures (SOPs) will be established to govern registry operations and
        analysis activities, covering patient recruitment, data collection, data management,
        analysis, adverse event reporting, and change management.
  
        Sample Size and Missing Data:
  
        A sample size assessment will be conducted to determine the number of participants or
        participant years required to demonstrate a statistically significant effect. A plan for
        handling missing data will be devised to address situations where variables are missing or
        inconsistent due to various reasons.
  
        Statistical Analysis Plan:
  
        A detailed statistical analysis plan will be developed, outlining the analytical principles
        and statistical techniques to address primary and secondary objectives outlined in the study
        protocol or plan. This will guide the analysis of data collected throughout the trial.
  
        In summary, this comprehensive protocol describes the structure, procedures, and quality
        measures of a clinical trial comparing the effectiveness of a digital therapy and traditional
        exercise therapy in managing chronic low back pain. The implementation of rigorous quality
        assurance procedures and data management strategies will ensure the reliability and validity
        of the study's findings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 11-point numeric rating scale（NRS）
  time frame: baseline，4 weeks and 16 weeks
  description: NRS;0=no pain, 10=unbearable pain
  measure: the Oswestry Disability Index (ODI)
  time frame: baseline，4 weeks and 16 weeks
  description: The ODI evaluated disability across 10 domains, encompassing pain intensity and functional abilities related to personal care, lifting, walking, sitting, standing, sleeping, sexual activities, social life, and traveling. Each domain was rated on a 6-point scale ranging from 0 to 5. A score of 0 indicated the highest level of functioning, while a score of 50 indicated total disability
  measure: The 36-item Short Form Health Survey (SF-36)
  time frame: baseline，4 weeks and 16 weeks
  description: it evaluates an individual's physical, mental, and social health experiences across eight domains, including Physical Functioning, Mental Health, and more. With 36 questions, responses are scored from 0 to 100, reflecting higher scores for better health status. Its brevity, versatility, and comprehensive health dimension coverage are notable advantages. The SF-36 finds applications in clinical practice, epidemiology, and health outcome studies, aiding in diagnosis, treatment, and policy decisions.
  arm group label: the digital therapy
  arm group type: Experimental
  description: The participants randomly assigned to the intervention group will receive home-based exercise training with human key-point detection.They will be instructed to complete a minimum of three sports training sessions per week at their preferred time and location.The exercise prescription will be formulated based on previous comprehensive studies, encompassing exercises targeting strength, balance, flexibility, and mobility.Human key point detection technology accurately estimates 25 key points of the human body in pictures or videos using visual detection.
  arm group label: traditional exercise therapy
  arm group type: Active Comparator
  description: The participants randomly assigned to the control group will receive traditional face-to-face exercise instruction. An experienced therapist( 10 years of experience) will be arranged to provide the subjects with 20-30 minutes of exercise instruction three times a week for four weeks. The training sessions were scheduled to start at 4 p.m. on Monday, Wednesday, and Friday of each week. The exercise training content selected for the control group will be consistent with that of the intervention group.
  intervention type: Behavioral
  intervention name: Improving Low Back Pain Through Motor Control Training
  description: In the digital healthcare group, participants utilized app-based online motor control training. In contrast, participants in the traditional treatment group underwent motor control training under the guidance of healthcare professionals at the hospital.
  arm group label: the digital therapy
  arm group label: traditional exercise therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
  investigator full name: Fuming Zheng
  investigator title: Principal Investigator
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No