<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/NCT03791164</url>
  </required_header>
  <id_info>
    <org_study_id>176/17</org_study_id>
    <nct_id>NCT03791164</nct_id>
  </id_info>
  <brief_title>A Comparison of Two Self-management Programmes for Patients With Back Pain</brief_title>
  <official_title>A Comparison of Two Different Self-management Programmes for Patients With Back Pain: A Double-blind Randomised Controlled Trial.</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>
      This investigation is a mixed methods research proposal to answer the question: 'Does Using&#xD;
      the Pain Toolkit Improve Outcomes for Patients accessing the North of England Regional Back&#xD;
      Pain Pathway?'. The study is part of a 5 year professional doctorate programme at Teesside&#xD;
      University. The aim of the study is to test whether with a double blind randomised controlled&#xD;
      trial patients accessing the North of England Regional Back Pain Pathway experience reduced&#xD;
      Oswestry Disability Index (ODI) when using the pain toolkit compared to a control group of&#xD;
      patients offered the standard treatment. The study also contains a nested qualitative element&#xD;
      which aims to explore the participants' experiences of using the Pain Toolkit.&#xD;
&#xD;
      According to the British Pain Society (2017), chronic pain management is a significant burden&#xD;
      to the National Health Service NHS. Back pain alone accounts for a significant disease burden&#xD;
      and loss in productivity among working people (Al Mazroa 2013 and TUC 2008). Commissioners&#xD;
      must justify their expenditure on health services to the local population and therefore for&#xD;
      an area such as pain management where there is significant disease prevalence (WHO 2013) and&#xD;
      significant costs, potential service developments should be considered. The development of&#xD;
      the pain toolkit (Pain Toolkit 2017a) as a straightforward, easy to use self-management&#xD;
      option offers a potentially cost effective support mechanism for patients but as yet there is&#xD;
      no evidence to support its use in clinical practice. This study aims to fill that knowledge&#xD;
      gap.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research Questions The overarching aim of this mixed methods study is to investigate whether&#xD;
      the use of a structured self-management programme (the Pain Toolkit) results in better&#xD;
      outcomes for patients with chronic back pain compared to usual care. There will be a&#xD;
      quantitative and qualitative component to the work. In the quantitative component patients&#xD;
      will complete outcome measure scores at baseline and then 6 and 12 months after receiving the&#xD;
      Pain Toolkit or the standard programme for self-management. In the qualitative component a&#xD;
      group of patients will be invited to participate in semi-structured interviews after using&#xD;
      the Pain Toolkit. The interviews will explore their experience of using of the toolkit, its&#xD;
      acceptability and ease of use.&#xD;
&#xD;
      The principle research question is:&#xD;
&#xD;
        1. To investigate the effectiveness of structured self-management (the Pain Toolkit)&#xD;
           compared to unstructured advice/information on function for patients discharged to&#xD;
           self-management from an evidence based back pain pathway.&#xD;
&#xD;
           The secondary research question is:&#xD;
&#xD;
        2. To investigate the effectiveness of structured self-management (the Pain Toolkit)&#xD;
           compared to unstructured self-management advice/information on pain for patients&#xD;
           discharged to self-management from an evidence based back pain pathway.&#xD;
&#xD;
        3. To investigate the effectiveness of structured self-management (the Pain Toolkit)&#xD;
           compared to unstructured self-management advice/information on quality of life for&#xD;
           patients discharged to self-management from an evidence based back pain pathway&#xD;
&#xD;
        4. To investigate the effectiveness of structured self-management (the Pain Toolkit)&#xD;
           compared to unstructured self-management advice/information on healthcare utilisation&#xD;
           for patients discharged to self-management from an evidence based back pain pathway&#xD;
&#xD;
        5. To explore patients' experiences of using the Pain Toolkit for self-management of pain&#xD;
&#xD;
      Background There is a wealth of literature outlining the disease burden of chronic pain and&#xD;
      in particular back pain, which forms the basis of the background to this study. Pain is&#xD;
      widespread in the UK with almost 10 million people affected almost every day (British Pain&#xD;
      Society 2015). More locally, for Durham Dales, Easington and Sedgefield Clinical&#xD;
      Commissioning Group (DDES CCG) where the student researcher works, the highest cost&#xD;
      prescribed drug is Pregabalin which is primarily used as a pain relieving medication. The CCG&#xD;
      spends in excess of £2m per year on this one drug alone (DDES 2016). Focussing on the&#xD;
      literature relating to back pain, the World Health Organisation state that: 'back pain is not&#xD;
      a disease but a constellation of symptoms. In most cases, the origins remain unknown' (WHO&#xD;
      2013). In 2010 the Global Burden of Disease Study estimated that low back pain was among the&#xD;
      top 10 diseases and injuries that account for the highest number of Disability Adjusted Life&#xD;
      Years worldwide (Al Mazroa 2013). The impact of this is demonstrated in the UK, by the Trades&#xD;
      Union Congress (TUC 2008) who reported that British businesses lose an estimated 4.9 million&#xD;
      days per year to work related back pain, with the North East of England suffering more than&#xD;
      most. Other authors concur that most people will experience low pain at some point in their&#xD;
      lives (Hoy, Brooks et al 2010 p769; Yang et al 2016 p459).&#xD;
&#xD;
      The full cost to the NHS of chronic pain and its management is not known (BPS 2017). For the&#xD;
      specific area of low back pain the World Health Organisation report back pain is one of&#xD;
      'seven high-burden conditions….for which the currently available treatment is inadequate in&#xD;
      reversing or halting the progression of disease '(WHO 2013 page x). The evidence above shows&#xD;
      that back pain is therefore such a widespread concern to patients and commissioners that it&#xD;
      is important to look for an evidence-based approach to manage it.&#xD;
&#xD;
      Using the research question: 'Does using the pain toolkit improve outcomes for patients&#xD;
      accessing the north of England regional back pain pathway?' the student researcher consulted&#xD;
      the following databases and found no results referencing the Pain Toolkit: AMED, EMBASE, OVID&#xD;
      on line, EBM, HMIC and CINAHL. This would indicate that the Pain Toolkit as a method for&#xD;
      self-management of pain has not been well studied. The search terms were widened to include&#xD;
      programmes of self-management of chronic pain. The same databases were searched using the&#xD;
      extended terms. 135 articles were returned from the search which was then narrowed by&#xD;
      removing duplicates and articles that were described as study protocols or descriptive&#xD;
      studies. 2 papers describing randomised control trials or RCTs were removed because they&#xD;
      related to a physical activity programme rather than self-management. One article found&#xD;
      during the literature review reported a review of RCTs which gave advice within&#xD;
      self-management programmes (Liddle, Gracey and Baxter 2007). This paper undertook a&#xD;
      systematic review of 39 randomised control trials exploring various aspects of advice on&#xD;
      self-management for patients with back pain. The authors concluded that 'No conclusions could&#xD;
      be drawn as to the frequency and content of advice that is most effective for LBP [lower back&#xD;
      pain] due to the limited number and poor quality of RCTs in this area' (Liddle, Gracey and&#xD;
      Baxter 2007 p310). They conclude that 'more investigation is needed into the role of&#xD;
      follow-up advice for chronic LBP patients' (Liddle, Gracey and Baxter p 327). They also found&#xD;
      that a wide variety of outcome measures were used in the various studies making meaningful&#xD;
      comparisons between the studies difficult.&#xD;
&#xD;
      As has been argued above, although back pain is a significant burden to patients and the NHS,&#xD;
      the area of self-management has not been well studied and there is no clear guidance as to&#xD;
      appropriate content for self-management programmes. The studies related to self-management&#xD;
      programmes are hampered by use of diverse outcome measures and lack of rigor. Consequently an&#xD;
      appropriately powered randomised control trial, using a validated outcome measure to assess&#xD;
      the effectiveness of a specific intervention, such as the pain toolkit, is required to&#xD;
      address these inadequacies in the literature.&#xD;
&#xD;
      To test the effectiveness of the pain toolkit the following experimental hypothesis has been&#xD;
      developed: Patients using the Pain Toolkit will report an outcome of a 10 point reduction in&#xD;
      the Oswestry Disability Index compared with patients using standard support.&#xD;
&#xD;
      Methods In the proposed study, the intervention of the Pain Toolkit is to be tested to see&#xD;
      whether its use in a specific cohort of patients with back pain at the point of discharge to&#xD;
      self-management, will improve health outcomes. In order to test this there will be 2 groups&#xD;
      of patients who are randomly allocated to receive either the pain toolkit or defined standard&#xD;
      treatment. Other study designs such as case control and cohort studies were considered,&#xD;
      however, because the study is prospective, involves the use of a specific intervention and is&#xD;
      time limited a randomised control trial was judged to be the most appropriate design. For the&#xD;
      qualitative aspect of the study a smaller cohort of 8-12 patients will be selected from the&#xD;
      group that receive the Pain Toolkit to participate in semi-structured interviews, loosely&#xD;
      based around the readiness to change theory (Kerns et al., 1997, Lorig and Stewart 1996).&#xD;
      This aspect of the study will explore participants' experiences of using the Pain Toolkit. A&#xD;
      flowchart showing the process for recruitment is shown at appendix 11. The questions within&#xD;
      the semi-structured interviews are designed to explore whether the participant had tried any&#xD;
      other self-management programmes prior to starting to use the intervention for the study.&#xD;
      This deductive approach had led to a conceptual framework that attitudes towards&#xD;
      self-management may be enhanced by structured literature to support the participant. This&#xD;
      concept will be explore during the qualitative aspect of the study and will give context to&#xD;
      the findings of the quantitative study.&#xD;
&#xD;
      Sample - Quantitative Study The study group will be a convenience sample of patients&#xD;
      accessing the back pain pathway at the point of discharge to self-management. Inclusion&#xD;
      criteria are: patients with back pain who have been referred to the North of England regional&#xD;
      back pain service who consent to take part in the study. Exclusion criteria are patients with&#xD;
      red flag indicators where immediate referral to secondary is indicated (NICE 2016). In&#xD;
      addition children less than 18 years and, people who do not speak English and people with&#xD;
      reduced mental capacity will be excluded. Although easy read versions of the toolkit are&#xD;
      available (Pain toolkit 2017b), the Back Book that will be used for the control group is only&#xD;
      available in English.&#xD;
&#xD;
      Using the NQUERY software, we estimate that a sample size of 70 in each group will have 90%&#xD;
      power to detect a difference in mean change of 10 points (this is considered by NICE to be a&#xD;
      clinically relevant change) between the intervention and comparator groups assuming that the&#xD;
      common standard deviation (SD) of change is 18 points using a two group t-test with a 0.050&#xD;
      two-sided significance level. The estimate of SD of change scores was obtained from some&#xD;
      previously collected data involving 967 participants. Ultimately, the data will be analysed&#xD;
      with a similar between-subjects model for comparison of change scores, but with covariate&#xD;
      adjustment for baseline measurements, age and sex. Similar studies show a 30% drop out rate.&#xD;
      Therefore to ensure that the study is appropriately powered, 100 participants will be&#xD;
      recruited for each group, giving a total of 200 participants overall.&#xD;
&#xD;
      The study will also consider refusals, drop outs and loses to follow up. This may include&#xD;
      patients who do not use the pain toolkit during the study period or who do not complete the&#xD;
      outcomes measures. It would potentially impact on the interpretation of the study results if&#xD;
      either of these groups were large in number, it will therefore be important to determine how&#xD;
      their results will be reported at the end of the study. An anticipated dropout rate of 30%&#xD;
      will be included in the power calculation.&#xD;
&#xD;
      Instruments and analysis are described elsewhere in the registration application.&#xD;
&#xD;
      Conclusion As shown previously the impact of reducing pain in patients will have significant&#xD;
      personal and economic benefits for patients and the whole health economy. The pain toolkit is&#xD;
      perceived as an easy to use, widely available self-management tool that could be given to&#xD;
      patients at any point in their pathway. There is however little evidence to back its use and&#xD;
      so research is needed in this area. Should the study prove that patients using the pain&#xD;
      toolkit experience a reduction in their ODI score this may indicate that it would be cost&#xD;
      effective to offer the pain toolkit more widely to patients. Conversely if the study shows&#xD;
      that there is little or no benefit in the use of the pain toolkit then alternative&#xD;
      self-management tools can be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>This is a randomised controlled trial, with a nested qualitative element</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigator and the outcome assessor are blinded as to which intervention the participants have been allocated until after data collection and evaluation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>a change in the Oswestry Disability Index</measure>
    <time_frame>baseline, 6 months and 1 year</time_frame>
    <description>the ODI is a measure of functionality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>baseline, 6 months and 1 year</time_frame>
    <description>a health outcome measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire relating to Healthcare Usage</measure>
    <time_frame>baseline, 6 months and 1 year</time_frame>
    <description>patients will be asked how frequently they have accessed healthcare</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical pain score</measure>
    <time_frame>baseline, 6 months and 1 year</time_frame>
    <description>Patients will be asked to rate their pain using a commonly used one-dimensional pain intensity scale: the 11-point NRS, the VAS from no pain (=0) to worst pain imaginable [=10 (or 100)] and the four-point categorical verbal rating scale (VRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lower Back Pain Chronic</condition>
  <arm_group>
    <arm_group_label>Pain Toolkit plus the Back Book</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who are being discharged from the regional back pain pathway who are allocated the 'Pain Toolkit' booklet along with the control intervention 'the Back Book'. They follow the interventions in the 'PainToolkit' for 12 months and are followed up 6 months and 1 year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Back Book</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants who are being discharged from the regional back pain pathway who are allocated 'the Back Book'. They are followed up 6 months and 1 year. This is the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Pain Toolkit</intervention_name>
    <description>the Pain Toolkit is a leaflet that encourages self management techniques for patients with chronic pain</description>
    <arm_group_label>Pain Toolkit plus the Back Book</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>the Back Book</intervention_name>
    <description>The Back Book is a patient information leaflet that offers information and advice about back pain</description>
    <arm_group_label>Back Book</arm_group_label>
    <arm_group_label>Pain Toolkit plus the Back Book</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  : patients with back pain who have been referred to the North of England regional back&#xD;
             pain service who consent to take part in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are patients with red flag indicators where immediate referral to&#xD;
             secondary is indicated (NICE 2016). In addition children less than 18 years and,&#xD;
             people who do not speak English and people with reduced mental capacity will be&#xD;
             excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>GILLIAN FINDLEY</last_name>
    <phone>07788903313</phone>
    <email>gillian.findley@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>CORMAC RYAN</last_name>
    <email>C.Ryan@tees.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>County Durham and Darlington Nhs Foundation Trust</name>
      <address>
        <city>Durham</city>
        <zip>DH15TW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DAVID ROLLINS</last_name>
      <phone>01325 743379</phone>
      <email>d.rollind@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>HELEN RIDING</last_name>
      <email>HELENRIDING@NHS.NET</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>May 5, 2019</last_update_submitted>
  <last_update_submitted_qc>May 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Gill Findley</investigator_full_name>
    <investigator_title>Principle Investigator</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>Yes</sharing_ipd>
    <ipd_description>Data relating to the study will be published as a technical appendix to any paper and will be available upon reasonable request once the results have been published</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>following publication of results</ipd_time_frame>
    <ipd_access_criteria>reasonable request to the author</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/NCT03791164
org study id: 176/17
nct id: NCT03791164
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This investigation is a mixed methods research proposal to answer the question: 'Does Using
      the Pain Toolkit Improve Outcomes for Patients accessing the North of England Regional Back
      Pain Pathway?'. The study is part of a 5 year professional doctorate programme at Teesside
      University. The aim of the study is to test whether with a double blind randomised controlled
      trial patients accessing the North of England Regional Back Pain Pathway experience reduced
      Oswestry Disability Index (ODI) when using the pain toolkit compared to a control group of
      patients offered the standard treatment. The study also contains a nested qualitative element
      which aims to explore the participants' experiences of using the Pain Toolkit.

      According to the British Pain Society (2017), chronic pain management is a significant burden
      to the National Health Service NHS. Back pain alone accounts for a significant disease burden
      and loss in productivity among working people (Al Mazroa 2013 and TUC 2008). Commissioners
      must justify their expenditure on health services to the local population and therefore for
      an area such as pain management where there is significant disease prevalence (WHO 2013) and
      significant costs, potential service developments should be considered. The development of
      the pain toolkit (Pain Toolkit 2017a) as a straightforward, easy to use self-management
      option offers a potentially cost effective support mechanism for patients but as yet there is
      no evidence to support its use in clinical practice. This study aims to fill that knowledge
      gap.
Research Questions The overarching aim of this mixed methods study is to investigate whether
      the use of a structured self-management programme (the Pain Toolkit) results in better
      outcomes for patients with chronic back pain compared to usual care. There will be a
      quantitative and qualitative component to the work. In the quantitative component patients
      will complete outcome measure scores at baseline and then 6 and 12 months after receiving the
      Pain Toolkit or the standard programme for self-management. In the qualitative component a
      group of patients will be invited to participate in semi-structured interviews after using
      the Pain Toolkit. The interviews will explore their experience of using of the toolkit, its
      acceptability and ease of use.

      The principle research question is:

        1. To investigate the effectiveness of structured self-management (the Pain Toolkit)
           compared to unstructured advice/information on function for patients discharged to
           self-management from an evidence based back pain pathway.

           The secondary research question is:

        2. To investigate the effectiveness of structured self-management (the Pain Toolkit)
           compared to unstructured self-management advice/information on pain for patients
           discharged to self-management from an evidence based back pain pathway.

        3. To investigate the effectiveness of structured self-management (the Pain Toolkit)
           compared to unstructured self-management advice/information on quality of life for
           patients discharged to self-management from an evidence based back pain pathway

        4. To investigate the effectiveness of structured self-management (the Pain Toolkit)
           compared to unstructured self-management advice/information on healthcare utilisation
           for patients discharged to self-management from an evidence based back pain pathway

        5. To explore patients' experiences of using the Pain Toolkit for self-management of pain

      Background There is a wealth of literature outlining the disease burden of chronic pain and
      in particular back pain, which forms the basis of the background to this study. Pain is
      widespread in the UK with almost 10 million people affected almost every day (British Pain
      Society 2015). More locally, for Durham Dales, Easington and Sedgefield Clinical
      Commissioning Group (DDES CCG) where the student researcher works, the highest cost
      prescribed drug is Pregabalin which is primarily used as a pain relieving medication. The CCG
      spends in excess of £2m per year on this one drug alone (DDES 2016). Focussing on the
      literature relating to back pain, the World Health Organisation state that: 'back pain is not
      a disease but a constellation of symptoms. In most cases, the origins remain unknown' (WHO
      2013). In 2010 the Global Burden of Disease Study estimated that low back pain was among the
      top 10 diseases and injuries that account for the highest number of Disability Adjusted Life
      Years worldwide (Al Mazroa 2013). The impact of this is demonstrated in the UK, by the Trades
      Union Congress (TUC 2008) who reported that British businesses lose an estimated 4.9 million
      days per year to work related back pain, with the North East of England suffering more than
      most. Other authors concur that most people will experience low pain at some point in their
      lives (Hoy, Brooks et al 2010 p769; Yang et al 2016 p459).

      The full cost to the NHS of chronic pain and its management is not known (BPS 2017). For the
      specific area of low back pain the World Health Organisation report back pain is one of
      'seven high-burden conditions….for which the currently available treatment is inadequate in
      reversing or halting the progression of disease '(WHO 2013 page x). The evidence above shows
      that back pain is therefore such a widespread concern to patients and commissioners that it
      is important to look for an evidence-based approach to manage it.

      Using the research question: 'Does using the pain toolkit improve outcomes for patients
      accessing the north of England regional back pain pathway?' the student researcher consulted
      the following databases and found no results referencing the Pain Toolkit: AMED, EMBASE, OVID
      on line, EBM, HMIC and CINAHL. This would indicate that the Pain Toolkit as a method for
      self-management of pain has not been well studied. The search terms were widened to include
      programmes of self-management of chronic pain. The same databases were searched using the
      extended terms. 135 articles were returned from the search which was then narrowed by
      removing duplicates and articles that were described as study protocols or descriptive
      studies. 2 papers describing randomised control trials or RCTs were removed because they
      related to a physical activity programme rather than self-management. One article found
      during the literature review reported a review of RCTs which gave advice within
      self-management programmes (Liddle, Gracey and Baxter 2007). This paper undertook a
      systematic review of 39 randomised control trials exploring various aspects of advice on
      self-management for patients with back pain. The authors concluded that 'No conclusions could
      be drawn as to the frequency and content of advice that is most effective for LBP [lower back
      pain] due to the limited number and poor quality of RCTs in this area' (Liddle, Gracey and
      Baxter 2007 p310). They conclude that 'more investigation is needed into the role of
      follow-up advice for chronic LBP patients' (Liddle, Gracey and Baxter p 327). They also found
      that a wide variety of outcome measures were used in the various studies making meaningful
      comparisons between the studies difficult.

      As has been argued above, although back pain is a significant burden to patients and the NHS,
      the area of self-management has not been well studied and there is no clear guidance as to
      appropriate content for self-management programmes. The studies related to self-management
      programmes are hampered by use of diverse outcome measures and lack of rigor. Consequently an
      appropriately powered randomised control trial, using a validated outcome measure to assess
      the effectiveness of a specific intervention, such as the pain toolkit, is required to
      address these inadequacies in the literature.

      To test the effectiveness of the pain toolkit the following experimental hypothesis has been
      developed: Patients using the Pain Toolkit will report an outcome of a 10 point reduction in
      the Oswestry Disability Index compared with patients using standard support.

      Methods In the proposed study, the intervention of the Pain Toolkit is to be tested to see
      whether its use in a specific cohort of patients with back pain at the point of discharge to
      self-management, will improve health outcomes. In order to test this there will be 2 groups
      of patients who are randomly allocated to receive either the pain toolkit or defined standard
      treatment. Other study designs such as case control and cohort studies were considered,
      however, because the study is prospective, involves the use of a specific intervention and is
      time limited a randomised control trial was judged to be the most appropriate design. For the
      qualitative aspect of the study a smaller cohort of 8-12 patients will be selected from the
      group that receive the Pain Toolkit to participate in semi-structured interviews, loosely
      based around the readiness to change theory (Kerns et al., 1997, Lorig and Stewart 1996).
      This aspect of the study will explore participants' experiences of using the Pain Toolkit. A
      flowchart showing the process for recruitment is shown at appendix 11. The questions within
      the semi-structured interviews are designed to explore whether the participant had tried any
      other self-management programmes prior to starting to use the intervention for the study.
      This deductive approach had led to a conceptual framework that attitudes towards
      self-management may be enhanced by structured literature to support the participant. This
      concept will be explore during the qualitative aspect of the study and will give context to
      the findings of the quantitative study.

      Sample - Quantitative Study The study group will be a convenience sample of patients
      accessing the back pain pathway at the point of discharge to self-management. Inclusion
      criteria are: patients with back pain who have been referred to the North of England regional
      back pain service who consent to take part in the study. Exclusion criteria are patients with
      red flag indicators where immediate referral to secondary is indicated (NICE 2016). In
      addition children less than 18 years and, people who do not speak English and people with
      reduced mental capacity will be excluded. Although easy read versions of the toolkit are
      available (Pain toolkit 2017b), the Back Book that will be used for the control group is only
      available in English.

      Using the NQUERY software, we estimate that a sample size of 70 in each group will have 90%
      power to detect a difference in mean change of 10 points (this is considered by NICE to be a
      clinically relevant change) between the intervention and comparator groups assuming that the
      common standard deviation (SD) of change is 18 points using a two group t-test with a 0.050
      two-sided significance level. The estimate of SD of change scores was obtained from some
      previously collected data involving 967 participants. Ultimately, the data will be analysed
      with a similar between-subjects model for comparison of change scores, but with covariate
      adjustment for baseline measurements, age and sex. Similar studies show a 30% drop out rate.
      Therefore to ensure that the study is appropriately powered, 100 participants will be
      recruited for each group, giving a total of 200 participants overall.

      The study will also consider refusals, drop outs and loses to follow up. This may include
      patients who do not use the pain toolkit during the study period or who do not complete the
      outcomes measures. It would potentially impact on the interpretation of the study results if
      either of these groups were large in number, it will therefore be important to determine how
      their results will be reported at the end of the study. An anticipated dropout rate of 30%
      will be included in the power calculation.

      Instruments and analysis are described elsewhere in the registration application.

      Conclusion As shown previously the impact of reducing pain in patients will have significant
      personal and economic benefits for patients and the whole health economy. The pain toolkit is
      perceived as an easy to use, widely available self-management tool that could be given to
      patients at any point in their pathway. There is however little evidence to back its use and
      so research is needed in this area. Should the study prove that patients using the pain
      toolkit experience a reduction in their ODI score this may indicate that it would be cost
      effective to offer the pain toolkit more widely to patients. Conversely if the study shows
      that there is little or no benefit in the use of the pain toolkit then alternative
      self-management tools can be explored.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomised controlled trial, with a nested qualitative element
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: The investigator and the outcome assessor are blinded as to which intervention the participants have been allocated until after data collection and evaluation
measure: a change in the Oswestry Disability Index
time frame: baseline, 6 months and 1 year
description: the ODI is a measure of functionality
measure: EQ-5D
time frame: baseline, 6 months and 1 year
description: a health outcome measure
measure: Questionnaire relating to Healthcare Usage
time frame: baseline, 6 months and 1 year
description: patients will be asked how frequently they have accessed healthcare
measure: Numerical pain score
time frame: baseline, 6 months and 1 year
description: Patients will be asked to rate their pain using a commonly used one-dimensional pain intensity scale: the 11-point NRS, the VAS from no pain (=0) to worst pain imaginable [=10 (or 100)] and the four-point categorical verbal rating scale (VRS)
arm group label: Pain Toolkit plus the Back Book
arm group type: Experimental
description: Participants who are being discharged from the regional back pain pathway who are allocated the 'Pain Toolkit' booklet along with the control intervention 'the Back Book'. They follow the interventions in the 'PainToolkit' for 12 months and are followed up 6 months and 1 year.
arm group label: Back Book
arm group type: Active Comparator
description: Participants who are being discharged from the regional back pain pathway who are allocated 'the Back Book'. They are followed up 6 months and 1 year. This is the control group.
intervention type: Behavioral
intervention name: The Pain Toolkit
description: the Pain Toolkit is a leaflet that encourages self management techniques for patients with chronic pain
arm group label: Pain Toolkit plus the Back Book
intervention type: Behavioral
intervention name: the Back Book
description: The Back Book is a patient information leaflet that offers information and advice about back pain
arm group label: Back Book
arm group label: Pain Toolkit plus the Back Book
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GILLIAN FINDLEY
phone: 07788903313
email: gillian.findley@nhs.net
last name: CORMAC RYAN
email: C.Ryan@tees.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Gill Findley
investigator title: Principle Investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Yes
ipd description: Data relating to the study will be published as a technical appendix to any paper and will be available upon reasonable request once the results have been published
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: following publication of results
ipd access criteria: reasonable request to the author