<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/NCT04447508</url>
  </required_header>
  <id_info>
    <org_study_id>E2020:025</org_study_id>
    <nct_id>NCT04447508</nct_id>
  </id_info>
  <brief_title>Reframe Your Pain: A Feasibility and Acceptability Study</brief_title>
  <official_title>Assessing the Feasibility and Acceptability of Reframe Your Pain to Enhance Exercise Adherence in People With Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mitacs</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manitoba</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>
      The study will follow guidelines provided by the ORBIT model for developing behavioural&#xD;
      treatments. This model proposes that to optimize an intervention's effectiveness, its&#xD;
      development should be undertaken in four phases. Phase 1 (design) and 2a (proof of concept)&#xD;
      were completed during the applicant's PhD. The study will complete phase 2b&#xD;
      (pilot-feasibility study) of the model with the aim to determine pre-defined feasibility&#xD;
      outcomes to inform future progression to phase 3 (efficacy trial) and 4 (effectiveness&#xD;
      trials).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately one in five Canadians suffer from persistent low back pain (PLBP). Experiencing&#xD;
      PLBP limits an individual's independence by impacting their ability to participate in family,&#xD;
      social and working life. Canada has the second highest rate of opioid prescribing in the&#xD;
      world and this comes with many risks, including an increase in admissions to addiction&#xD;
      programs and opioid related deaths. Due to the widespread economic, personal and social&#xD;
      impacts, World Health Organization burden of disease profiles have shifted focus from the&#xD;
      treatment of communicable disease to the treatment of non-communicable, long term diseases,&#xD;
      including non-pharmaceutical treatment of PLBP.&#xD;
&#xD;
      Active treatment, including physical activity and exercise has been shown to effectively&#xD;
      reduce pain severity while increasing function and quality of life in patients with PLBP.&#xD;
      However, over half of the patients that are prescribed exercises as treatment for their&#xD;
      conditions do not adhere and there is a recognized gap in the literature of research&#xD;
      exploring exercise adherence in this population.&#xD;
&#xD;
      Preliminary work in this research program included the development and initial testing of a&#xD;
      behaviour change intervention to enhance exercise adherence in a population PLBP. Using the&#xD;
      intervention development framework Intervention Mapping, a group-based exercise program&#xD;
      incorporating an exercise app and one on one psychological support was developed. However,&#xD;
      assessment within a Canadian context, its clinical significance and efficacy for wider&#xD;
      implementation have not yet been assessed.&#xD;
&#xD;
      The primary objective of the proposed project is to inform progression to a large scale&#xD;
      randomized controlled trial of the intervention (vs usual care) through the evaluation of a&#xD;
      pilot-feasibility trial and an efficacy trial.The study will employ a two-arm randomized&#xD;
      controlled pilot-feasibility study with a nested qualitative interview study.&#xD;
&#xD;
      The purpose of pilot-feasibility trials is to assess feasibility of a protocol to provide&#xD;
      estimates for an efficacy trail. Therefore, while the design may look similar to an efficacy&#xD;
      trial, clinical outcomes are not the primary outcome. Due to their smaller sample size,&#xD;
      pilot-feasibility studies may provide unstable estimate of effect size, however their&#xD;
      assessment will determine the sample size needed for the efficacy trial. This study will&#xD;
      allow for the feasibility of transferring the program from a UK context (where it was&#xD;
      originally tested) to a Winnipeg setting.&#xD;
&#xD;
      The program offered will be delivered to patients with PLBP as an adjunct to physiotherapy&#xD;
      designed to facilitate self-management to enhance exercise adherence. Patients receiving the&#xD;
      intervention will be asked to complete an online instructor led group exercise class and five&#xD;
      online one on one motivational interviewing sessions.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objectives of the study are to:&#xD;
&#xD;
      (i) determine feasibility of recruitment (ii) determine adherence to study protocol (iii)&#xD;
      determine completion rates of outcome measures (iv) provide parameters needed for sample size&#xD;
      calculations for future research&#xD;
&#xD;
      Methods Participants will be recruited through the Spine Assessment Clinic at the Health&#xD;
      Sciences Centre and the study will be conducted at the Reh Fit Centre. The signed informed&#xD;
      consent form will be collected at the baseline meeting and baseline measures collected.&#xD;
      Participants will then be randomised to the intervention or control group (computer&#xD;
      generated). Allocation will be single blinded as the personnel delivering the intervention&#xD;
      will be aware of who is in the intervention group. However an independent researcher&#xD;
      (research assistant) will collect and anonymise the data prior to analyses.&#xD;
&#xD;
      All participants will be provided with the exercise program booklet and exercise diary.&#xD;
      Control participants will be asked to compete the exercises twice a week. Intervention&#xD;
      participants will be scheduled for their motivational interviewing sessions and enrolled in&#xD;
      the exercise program.&#xD;
&#xD;
      Participants randomised to the intervention will be enrolled in the group exercise class. The&#xD;
      class will be a rolling start, so that participants will start the exercise class once&#xD;
      enrolled in the study and finishing after six weeks. Therefore, not all participants will&#xD;
      start at the same time to avoid some participants waiting for a long duration until 10&#xD;
      participants are randomised to the intervention group. The exercise class will be one hour in&#xD;
      duration and run once a week for 6 weeks. It will be conducted virtually using Zoom.&#xD;
&#xD;
      Four motivational interviewing sessions will be provided concurrently with the group exercise&#xD;
      class and held over Zoom. Motivational interviewing is a person-centered form of&#xD;
      communication to support behaviour change. These sessions, informed by behaviour change&#xD;
      theory, employ motivational techniques guided by the motivational interviewing protocol. The&#xD;
      sessions are typically 30-45 minutes in duration and guided by the needs of the participant,&#xD;
      however to inform progress and training, a guideline has been previously created during the&#xD;
      applicant's PhD to ensure behaviour change methods are being utilised. The first session will&#xD;
      occur at the start of the intervention with the duration between each appointment doubling&#xD;
      each time. Following completion of the exercise class participants will be asked to attend a&#xD;
      final online (Zoom) follow up motivational interviewing sessions at six weeks post&#xD;
      intervention. The content of this session will be similar to the previous sessions and driven&#xD;
      by the participant, however will be to assess the self-management techniques the participant&#xD;
      may or may not have used to continue to engage with their exercises on their own. Zoom is an&#xD;
      encrypted software that allows for secure web conferencing. Health support provided by&#xD;
      e-health programming is becoming more prominent in the literature and promotes accessibility&#xD;
      and cost-effectiveness to care. Motivational interviewing has been provided to patients with&#xD;
      persistent pain and its delivery within this context is warranted.&#xD;
&#xD;
      Following completion of the final follow up, participants will be invited to complete a&#xD;
      qualitative interview with researchers to assess acceptability of the intervention, as well&#xD;
      as to explore personnel most appropriate to deliver motivational interviewing. Staff involved&#xD;
      in delivering the intervention will also be invited to provide their views of acceptability&#xD;
      of intervention implementation. The interview topic guides will be informed by the&#xD;
      Theoretical Framework of Acceptability which outlines seven constructs to assess program&#xD;
      acceptability; ethicality, affective attitude, burden, opportunity costs, perceived&#xD;
      effectiveness, self-efficacy, and intervention coherence. These interviews will be conducted&#xD;
      by an independent researcher (research assistant) to facilitate open and honest responses by&#xD;
      the participants.&#xD;
&#xD;
      Following the acceptability interviews participants will be debriefed on the study. This will&#xD;
      take approximately 5 minutes and the research assistant will share with the participant the&#xD;
      rationale and purpose of the study and explain which group they were randomised to. For&#xD;
      control participants this will take place following their completion of the final&#xD;
      questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to restrictions pertaining to COVD study has been halted&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2021</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">April 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eligibility</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Number of eligible participants identified/week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Percentage of eligible participants recruited/week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment completion</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Percentage of participants that complete at least 3 of 5 motivational interviewing sessions and 5 of the 6 exercise classes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follow up</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Loss of follow up at 6 weeks post intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion of outcome measures</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Percentage of participants that complete baseline and follow up measures and complete exercise diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence rating scale (EARS)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
    <description>16 item questionnaire on 5-point Likert scale (0-completely agree, 4-completely disagree) higher scores indicating stronger adherence to exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaire</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
    <description>17 item questionnaire to determine yellow flags to outcomes. Domains measured include negative mood, fear-avoidance, positive affect/coping. Higher scores equate to better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculoskeletal health (MSK-HQ)</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
    <description>14 item questionnaire to measure constructs of pain and function. The item is scored on a range of 0-56, with a better score indicating better MSK-HQ health status. The total score is calculated by adding the numbers next to the box that the respondent has ticked on the questionnaire form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Action Process Approach (HAPA)constructs</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
    <description>Measures domains of outcome expectations,risk perception,self-efficacy, action and coping plans; the variables of the theoretical model underpinning the intervention. Each domain has one question with 5 anchor points on a 4 point Likert scale (0-not true at all, 4-Exactly true). Higher scores indicate stronger strong use of the concepts. A change in scores will indicate if the intervention targeted the concepts it is theorized to target.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence self report</measure>
    <time_frame>Through study completion, up to 12 weeks</time_frame>
    <description>Exercise log</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Exercise class and motivational interviewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving the intervention will be enrolled in an online instructor led group exercise class and five online one on one motivational interviewing sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive an exercise booklet and educated on the benefits of exercise for low back pain. They will be advised to exercise for the duration of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Participants receive one on one motivational interviewing and participate in a group exercise class virtually.</intervention_name>
    <description>Participants have one group exercise class over zoom per week and an online one on one motivational interviewing session every second week.</description>
    <arm_group_label>Exercise class and motivational interviewing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (over 18 years old)&#xD;
&#xD;
          -  Low back pain for three months or longer and no current plans for surgical&#xD;
             intervention&#xD;
&#xD;
          -  Previously been prescribed exercises by a physiotherapist&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Plans for long absences during the study period&#xD;
&#xD;
          -  Participating in other studies or interventions targeting exercise or behaviour change&#xD;
             during study&#xD;
&#xD;
          -  Recent (2 months) changes to medications&#xD;
&#xD;
          -  Receiving or have received prior psychological interventions for their pain (i.e.,&#xD;
             cognitive behavioural therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Summers S. Evidence-based practice part 1: pain definitions, pathophysiologic mechanisms, and theories. J Perianesth Nurs. 2000 Oct;15(5):357-65. doi: 10.1053/jpan.2000.18211.</citation>
    <PMID>11811340</PMID>
  </reference>
  <reference>
    <citation>Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.</citation>
    <PMID>3461421</PMID>
  </reference>
  <reference>
    <citation>Briggs AM, Woolf AD, Dreinhofer K, Homb N, Hoy DG, Kopansky-Giles D, Akesson K, March L. Reducing the global burden of musculoskeletal conditions. Bull World Health Organ. 2018 May 1;96(5):366-368. doi: 10.2471/BLT.17.204891. Epub 2018 Apr 12. No abstract available.</citation>
    <PMID>29875522</PMID>
  </reference>
  <reference>
    <citation>Gomes T, Mamdani MM, Dhalla IA, Cornish S, Paterson JM, Juurlink DN. The burden of premature opioid-related mortality. Addiction. 2014 Sep;109(9):1482-8. doi: 10.1111/add.12598. Epub 2014 Jul 7.</citation>
    <PMID>25041316</PMID>
  </reference>
  <reference>
    <citation>Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.</citation>
    <PMID>28436583</PMID>
  </reference>
  <reference>
    <citation>Meade LB, Bearne LM, Sweeney LH, Alageel SH, Godfrey EL. Behaviour change techniques associated with adherence to prescribed exercise in patients with persistent musculoskeletal pain: Systematic review. Br J Health Psychol. 2019 Feb;24(1):10-30. doi: 10.1111/bjhp.12324. Epub 2018 Jun 17.</citation>
    <PMID>29911311</PMID>
  </reference>
  <reference>
    <citation>Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.</citation>
    <PMID>25642841</PMID>
  </reference>
  <reference>
    <citation>Kok G, Gottlieb NH, Peters GJ, Mullen PD, Parcel GS, Ruiter RA, Fernandez ME, Markham C, Bartholomew LK. A taxonomy of behaviour change methods: an Intervention Mapping approach. Health Psychol Rev. 2016 Sep;10(3):297-312. doi: 10.1080/17437199.2015.1077155. Epub 2015 Oct 15.</citation>
    <PMID>26262912</PMID>
  </reference>
  <reference>
    <citation>Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.</citation>
    <PMID>17716083</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Laura Meade</investigator_full_name>
    <investigator_title>Principle Investigator,Postdoctoral Research Fellow</investigator_title>
  </responsible_party>
  <keyword>Pain, behaviour change, exercise</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>Undecided</sharing_ipd>
    <ipd_description>Feasibility outcomes may be shared with other researchers to inform progression in other parallel research</ipd_description>
  </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/NCT04447508
org study id: E2020:025
nct id: NCT04447508
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will follow guidelines provided by the ORBIT model for developing behavioural
      treatments. This model proposes that to optimize an intervention's effectiveness, its
      development should be undertaken in four phases. Phase 1 (design) and 2a (proof of concept)
      were completed during the applicant's PhD. The study will complete phase 2b
      (pilot-feasibility study) of the model with the aim to determine pre-defined feasibility
      outcomes to inform future progression to phase 3 (efficacy trial) and 4 (effectiveness
      trials).
Approximately one in five Canadians suffer from persistent low back pain (PLBP). Experiencing
      PLBP limits an individual's independence by impacting their ability to participate in family,
      social and working life. Canada has the second highest rate of opioid prescribing in the
      world and this comes with many risks, including an increase in admissions to addiction
      programs and opioid related deaths. Due to the widespread economic, personal and social
      impacts, World Health Organization burden of disease profiles have shifted focus from the
      treatment of communicable disease to the treatment of non-communicable, long term diseases,
      including non-pharmaceutical treatment of PLBP.

      Active treatment, including physical activity and exercise has been shown to effectively
      reduce pain severity while increasing function and quality of life in patients with PLBP.
      However, over half of the patients that are prescribed exercises as treatment for their
      conditions do not adhere and there is a recognized gap in the literature of research
      exploring exercise adherence in this population.

      Preliminary work in this research program included the development and initial testing of a
      behaviour change intervention to enhance exercise adherence in a population PLBP. Using the
      intervention development framework Intervention Mapping, a group-based exercise program
      incorporating an exercise app and one on one psychological support was developed. However,
      assessment within a Canadian context, its clinical significance and efficacy for wider
      implementation have not yet been assessed.

      The primary objective of the proposed project is to inform progression to a large scale
      randomized controlled trial of the intervention (vs usual care) through the evaluation of a
      pilot-feasibility trial and an efficacy trial.The study will employ a two-arm randomized
      controlled pilot-feasibility study with a nested qualitative interview study.

      The purpose of pilot-feasibility trials is to assess feasibility of a protocol to provide
      estimates for an efficacy trail. Therefore, while the design may look similar to an efficacy
      trial, clinical outcomes are not the primary outcome. Due to their smaller sample size,
      pilot-feasibility studies may provide unstable estimate of effect size, however their
      assessment will determine the sample size needed for the efficacy trial. This study will
      allow for the feasibility of transferring the program from a UK context (where it was
      originally tested) to a Winnipeg setting.

      The program offered will be delivered to patients with PLBP as an adjunct to physiotherapy
      designed to facilitate self-management to enhance exercise adherence. Patients receiving the
      intervention will be asked to complete an online instructor led group exercise class and five
      online one on one motivational interviewing sessions.

      Objectives:

      The primary objectives of the study are to:

      (i) determine feasibility of recruitment (ii) determine adherence to study protocol (iii)
      determine completion rates of outcome measures (iv) provide parameters needed for sample size
      calculations for future research

      Methods Participants will be recruited through the Spine Assessment Clinic at the Health
      Sciences Centre and the study will be conducted at the Reh Fit Centre. The signed informed
      consent form will be collected at the baseline meeting and baseline measures collected.
      Participants will then be randomised to the intervention or control group (computer
      generated). Allocation will be single blinded as the personnel delivering the intervention
      will be aware of who is in the intervention group. However an independent researcher
      (research assistant) will collect and anonymise the data prior to analyses.

      All participants will be provided with the exercise program booklet and exercise diary.
      Control participants will be asked to compete the exercises twice a week. Intervention
      participants will be scheduled for their motivational interviewing sessions and enrolled in
      the exercise program.

      Participants randomised to the intervention will be enrolled in the group exercise class. The
      class will be a rolling start, so that participants will start the exercise class once
      enrolled in the study and finishing after six weeks. Therefore, not all participants will
      start at the same time to avoid some participants waiting for a long duration until 10
      participants are randomised to the intervention group. The exercise class will be one hour in
      duration and run once a week for 6 weeks. It will be conducted virtually using Zoom.

      Four motivational interviewing sessions will be provided concurrently with the group exercise
      class and held over Zoom. Motivational interviewing is a person-centered form of
      communication to support behaviour change. These sessions, informed by behaviour change
      theory, employ motivational techniques guided by the motivational interviewing protocol. The
      sessions are typically 30-45 minutes in duration and guided by the needs of the participant,
      however to inform progress and training, a guideline has been previously created during the
      applicant's PhD to ensure behaviour change methods are being utilised. The first session will
      occur at the start of the intervention with the duration between each appointment doubling
      each time. Following completion of the exercise class participants will be asked to attend a
      final online (Zoom) follow up motivational interviewing sessions at six weeks post
      intervention. The content of this session will be similar to the previous sessions and driven
      by the participant, however will be to assess the self-management techniques the participant
      may or may not have used to continue to engage with their exercises on their own. Zoom is an
      encrypted software that allows for secure web conferencing. Health support provided by
      e-health programming is becoming more prominent in the literature and promotes accessibility
      and cost-effectiveness to care. Motivational interviewing has been provided to patients with
      persistent pain and its delivery within this context is warranted.

      Following completion of the final follow up, participants will be invited to complete a
      qualitative interview with researchers to assess acceptability of the intervention, as well
      as to explore personnel most appropriate to deliver motivational interviewing. Staff involved
      in delivering the intervention will also be invited to provide their views of acceptability
      of intervention implementation. The interview topic guides will be informed by the
      Theoretical Framework of Acceptability which outlines seven constructs to assess program
      acceptability; ethicality, affective attitude, burden, opportunity costs, perceived
      effectiveness, self-efficacy, and intervention coherence. These interviews will be conducted
      by an independent researcher (research assistant) to facilitate open and honest responses by
      the participants.

      Following the acceptability interviews participants will be debriefed on the study. This will
      take approximately 5 minutes and the research assistant will share with the participant the
      rationale and purpose of the study and explain which group they were randomised to. For
      control participants this will take place following their completion of the final
      questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Eligibility
time frame: Through study completion, up to 12 weeks
description: Number of eligible participants identified/week
measure: Recruitment
time frame: Through study completion, up to 12 weeks
description: Percentage of eligible participants recruited/week
measure: Treatment completion
time frame: Through study completion, up to 12 weeks
description: Percentage of participants that complete at least 3 of 5 motivational interviewing sessions and 5 of the 6 exercise classes
measure: Follow up
time frame: Through study completion, up to 12 weeks
description: Loss of follow up at 6 weeks post intervention
measure: Completion of outcome measures
time frame: Through study completion, up to 12 weeks
description: Percentage of participants that complete baseline and follow up measures and complete exercise diary
measure: Exercise adherence rating scale (EARS)
time frame: Baseline, 6 weeks, 12 weeks
description: 16 item questionnaire on 5-point Likert scale (0-completely agree, 4-completely disagree) higher scores indicating stronger adherence to exercise.
measure: Optimal Screening for Prediction of Referral and Outcome (OSPRO) questionnaire
time frame: Baseline, 6 weeks, 12 weeks
description: 17 item questionnaire to determine yellow flags to outcomes. Domains measured include negative mood, fear-avoidance, positive affect/coping. Higher scores equate to better outcomes.
measure: Musculoskeletal health (MSK-HQ)
time frame: Baseline, 6 weeks, 12 weeks
description: 14 item questionnaire to measure constructs of pain and function. The item is scored on a range of 0-56, with a better score indicating better MSK-HQ health status. The total score is calculated by adding the numbers next to the box that the respondent has ticked on the questionnaire form.
measure: Health Action Process Approach (HAPA)constructs
time frame: Baseline, 6 weeks, 12 weeks
description: Measures domains of outcome expectations,risk perception,self-efficacy, action and coping plans; the variables of the theoretical model underpinning the intervention. Each domain has one question with 5 anchor points on a 4 point Likert scale (0-not true at all, 4-Exactly true). Higher scores indicate stronger strong use of the concepts. A change in scores will indicate if the intervention targeted the concepts it is theorized to target.
measure: Exercise adherence self report
time frame: Through study completion, up to 12 weeks
description: Exercise log
arm group label: Exercise class and motivational interviewing
arm group type: Experimental
description: Patients receiving the intervention will be enrolled in an online instructor led group exercise class and five online one on one motivational interviewing sessions.
arm group label: Usual care
arm group type: No Intervention
description: Participants in the control group will receive an exercise booklet and educated on the benefits of exercise for low back pain. They will be advised to exercise for the duration of the study
intervention type: Behavioral
intervention name: Participants receive one on one motivational interviewing and participate in a group exercise class virtually.
description: Participants have one group exercise class over zoom per week and an online one on one motivational interviewing session every second week.
arm group label: Exercise class and motivational interviewing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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PMID: 28436583
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PMID: 29911311
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PMID: 25642841
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PMID: 26262912
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PMID: 17716083
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Laura Meade
investigator title: Principle Investigator,Postdoctoral Research Fellow
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided
ipd description: Feasibility outcomes may be shared with other researchers to inform progression in other parallel research