<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/NCT03804567</url>
  </required_header>
  <id_info>
    <org_study_id>163/18</org_study_id>
    <nct_id>NCT03804567</nct_id>
  </id_info>
  <brief_title>Oldpain2go®: an Exploratory (Pre-Feasibility) Study.</brief_title>
  <acronym>Oldpain2go®</acronym>
  <official_title>Oldpain2go®: an Exploratory (Pre-Feasibility) Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teesside University</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>
      Research question: Is there any evidence to suggest that the oldpain2go® intervention merits&#xD;
      scientific investigation?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims:&#xD;
&#xD;
        1. To collect data to:&#xD;
&#xD;
             1. give an indication of the potential effect size, of any effects, from the&#xD;
                oldpain2go® intervention, in people with persistent low back pain.&#xD;
&#xD;
             2. to explore the eligibility criteria, recruitment methods and materials proposed&#xD;
                here, for potential use in a future Feasibility study, of the oldpain2go®&#xD;
                intervention.&#xD;
&#xD;
        2. To compare demographic characteristics, medical history and outcome measure data of:&#xD;
&#xD;
             1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session),&#xD;
                with those for whom it is not,&#xD;
&#xD;
             2. people for whom the Oldpain2go® intervention works, after one treatment, with those&#xD;
                for whom it does not, and&#xD;
&#xD;
             3. people for whom the Oldpain2go® intervention works, after one, or two, treatments,&#xD;
                with those for whom it does not work after two treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain</measure>
    <time_frame>Change measures at three points, baseline, 1 week and 2 weeks from baseline</time_frame>
    <description>A self reported pain level scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Roland Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Change measures at three points, baseline, 1 week and 2 weeks from baseline</time_frame>
    <description>A measure of disability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Oldpain2go®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine low back pain management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Normal accepted physiotherapy treatment for persistent low back pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oldpain2go®</intervention_name>
    <description>This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs such as chronic pain that are troubling them.</description>
    <arm_group_label>Oldpain2go®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine low back pain management</intervention_name>
    <description>Standard low back persistent physiotherapy management as recommended by national guidelines.</description>
    <arm_group_label>Routine low back pain management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently suffering from persistent, non-specific, low back pain&#xD;
&#xD;
          -  Aged over 18 years&#xD;
&#xD;
          -  For whom Oldpain2go® is indicated as a treatment option after the standard clinical&#xD;
             screening process for the Oldpain2go® treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any Red Flags,&#xD;
&#xD;
          -  Any causative (or potentially causative) structural abnormality, or pathology detected&#xD;
             or suspected&#xD;
&#xD;
          -  Any concurrent pathology, or condition that would limit options for Physiotherapy&#xD;
             treatment,&#xD;
&#xD;
          -  Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alasdair MacSween, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Teesside University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norton Physiotherapy Centre</name>
      <address>
        <city>Norton</city>
        <state>Stockton-on-Tees</state>
        <zip>TS20 2PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Alasdair MacSween</investigator_full_name>
    <investigator_title>Principal Lecturer in Research Governance</investigator_title>
  </responsible_party>
  <keyword>Oldpain2go®</keyword>
  <keyword>Feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic 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/NCT03804567
org study id: 163/18
nct id: NCT03804567
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Research question: Is there any evidence to suggest that the oldpain2go® intervention merits
      scientific investigation?
Aims:

        1. To collect data to:

             1. give an indication of the potential effect size, of any effects, from the
                oldpain2go® intervention, in people with persistent low back pain.

             2. to explore the eligibility criteria, recruitment methods and materials proposed
                here, for potential use in a future Feasibility study, of the oldpain2go®
                intervention.

        2. To compare demographic characteristics, medical history and outcome measure data of:

             1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session),
                with those for whom it is not,

             2. people for whom the Oldpain2go® intervention works, after one treatment, with those
                for whom it does not, and

             3. people for whom the Oldpain2go® intervention works, after one, or two, treatments,
                with those for whom it does not work after two treatments.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
time frame: Change measures at three points, baseline, 1 week and 2 weeks from baseline
description: A self reported pain level scale
measure: The Roland Morris Disability Questionnaire (RMDQ)
time frame: Change measures at three points, baseline, 1 week and 2 weeks from baseline
description: A measure of disability
arm group label: Oldpain2go®
arm group type: Experimental
description: This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs (chronic pain) that are troubling them.
arm group label: Routine low back pain management
arm group type: Active Comparator
description: Normal accepted physiotherapy treatment for persistent low back pain.
intervention type: Other
intervention name: Oldpain2go®
description: This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs such as chronic pain that are troubling them.
arm group label: Oldpain2go®
intervention type: Other
intervention name: Routine low back pain management
description: Standard low back persistent physiotherapy management as recommended by national guidelines.
arm group label: Routine low back pain management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alasdair MacSween, Dr
role: Principal Investigator
affiliation: Teesside University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Alasdair MacSween
investigator title: Principal Lecturer in Research Governance
mesh term: Chronic Pain