<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/NCT04463043</url>
  </required_header>
  <id_info>
    <org_study_id>64084</org_study_id>
    <nct_id>NCT04463043</nct_id>
  </id_info>
  <brief_title>An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation</brief_title>
  <official_title>The Effectiveness of an App-based (selfBACK) Versus a Web-based (e-Help) Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation: a Three Arm Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of an individually tailored&#xD;
      self-management intervention, the selfBACK app, in improving health status in patients on a&#xD;
      waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a&#xD;
      non-tailored web-based self-management solution (e-Help) and usual care only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back,&#xD;
      neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway,&#xD;
      due to low back and/or neck pain are the target group for this study. The average waiting&#xD;
      time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial&#xD;
      approach to support self-management during the waiting period. Therefore, the effectiveness&#xD;
      of these tools in this patients group needs to be evaluated.&#xD;
&#xD;
      A total of 279 participants will be recruited and randomly allocated to one of the three&#xD;
      groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to&#xD;
      usual care; and 3) usual care only. Participants who receive either the selfBACK app and the&#xD;
      e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.&#xD;
&#xD;
      Self-reported outcome measures will be collected through web-based questionnaires at three&#xD;
      follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In&#xD;
      addition, participants receiving the selfBACK app will be asked a set of weekly tailoring&#xD;
      questions to individualize self-management plans. Objective registry based data linked to&#xD;
      social security number in Norway will be used to investigate health care consumption and&#xD;
      sickness absence at 1 year (and up to 5 years).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">December 3, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>This study is a single-blinded trial. Participants and health personnel at the clinic will not be blinded to group allocation, whereas researchers performing the analysis and the interpretation of the results will be blinded to group allocation. Once the study is completed, the data will be extracted from the database in anonymized form for statistical analyses, i.e. all personal information that may identify specific participants or group allocation will be removed and the intervention and control groups will be randomly labelled as A, B and C.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Musculoskeletal Health Questionnaire (MSK-HQ)</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain-related disability for low back pain</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-related disability for neck pain</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain intensity</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The average pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worst pain intensity</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The worst pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The EuroQoL 5-dimension (EQ-5D) questionnaire is used to assess health-related quality of life. 5 items scored 0 - 5 plus visual analogue scale scored 0- 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain self-efficacy</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Pain Self-Efficacy Questionnaire (PSEQ) is used to assess participants' level of confidence in carrying out specific activities despite their pain. 10 items scored 0 - 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness perception</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fear avoidance belief</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Fear-Avoidance Belief Questionnaire (FABQ) - physical activity subscale is used to measure participant's beliefs about how physical activity affect their low back and/or neck pain. 5 items scored 0 - 6</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress symptoms</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Perceived Stress Scale (PSS) is used to evaluate stress levels. 10 items scored 0 - 4.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Patient Health Questionnaire-2 (PHQ-2) is used to evaluate patients' depressive symptoms. 2 items scored 0 - 3.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional change</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The Patient Specific Functional Scale (PSFS) is used to evaluate changes in participant's ability to perform up to two self-selected activities regarded as important by them. Ability levels scored 0 - 10.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported physical activity</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The modernised Saltin-Grimby Physical Activity Level Scale is used to evaluate self-reported leisure time physical activity. 1 item (4 options).</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported sleep</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Sleep problems are assessed by four self-report items which provide information needed to diagnose insomnia according to the DSM-V criteria. 4 items scored 0 - 2.</description>
  </other_outcome>
  <other_outcome>
    <measure>Work ability</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Work ability index (WAI) is used to assess work ability. 1-item rated on an 11-point numeric rating scale (0='completely unable to work' to 10='work ability at its best').</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with intervention</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Acceptable Symptom State (PASS) is used to determine if patients consider themselves well and, as such, are satisfied with the treatment. 1 item (yes/no)</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived effect</measure>
    <time_frame>3 months</time_frame>
    <description>Patient's Global Perceived Effect is used to investigate participants' perception of effect from the intervention they received. 1 item scored -5 to 5</description>
  </other_outcome>
  <other_outcome>
    <measure>Health care consumption</measure>
    <time_frame>1 year</time_frame>
    <description>Objective registry based data linked to social security number in Norway are used to investigate health care consumption.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sickness absence</measure>
    <time_frame>1 year</time_frame>
    <description>Objective registry based data linked to social security number in Norway are used to investigate sickness absence.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">294</enrollment>
  <condition>Back Pain</condition>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>SelfBACK app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The selfBACK app in addition to usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>e-Help webpage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The e-Help webpage in addition to usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care only</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SelfBACK app</intervention_name>
    <description>The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.</description>
    <arm_group_label>SelfBACK app</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>e-Help webpage</intervention_name>
    <description>The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.</description>
    <arm_group_label>e-Help webpage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care refers to seeking care or receiving treatments or help as usual.</description>
    <arm_group_label>SelfBACK app</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_label>e-Help webpage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On waiting list for treatment at the multidisciplinary outpatient clinic for back,&#xD;
             neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital,&#xD;
             Norway due to low back pain and/or neck pain&#xD;
&#xD;
          -  Own and use a smartphone with internet access to download the mobile application&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients&#xD;
             prioritized for urgent treatment/examination)&#xD;
&#xD;
          -  Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use&#xD;
             of walking aids, unable to get up and down the floor independently&#xD;
&#xD;
          -  Unable to speak and/or read Norwegian&#xD;
&#xD;
          -  Unable to complete the baseline questionnaire&#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>Siri Forsmo, phd prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.</citation>
    <PMID>34518253</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>self-management</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>mHealth</keyword>
  <keyword>eHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be available, including data dictionaries. Data available to share include individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Beginning 5 years after end of trial and ending 30 years after end of trial.</ipd_time_frame>
    <ipd_access_criteria>Investigators whose proposed use of the data has been approved by the national ethics committee. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement. Information regarding submitting proposals and accessing data may be found at (Link will be provided after completing the trial).</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/NCT04463043
org study id: 64084
nct id: NCT04463043
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effectiveness of an individually tailored
      self-management intervention, the selfBACK app, in improving health status in patients on a
      waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a
      non-tailored web-based self-management solution (e-Help) and usual care only.
Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back,
      neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway,
      due to low back and/or neck pain are the target group for this study. The average waiting
      time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial
      approach to support self-management during the waiting period. Therefore, the effectiveness
      of these tools in this patients group needs to be evaluated.

      A total of 279 participants will be recruited and randomly allocated to one of the three
      groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to
      usual care; and 3) usual care only. Participants who receive either the selfBACK app and the
      e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual.

      Self-reported outcome measures will be collected through web-based questionnaires at three
      follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In
      addition, participants receiving the selfBACK app will be asked a set of weekly tailoring
      questions to individualize self-management plans. Objective registry based data linked to
      social security number in Norway will be used to investigate health care consumption and
      sickness absence at 1 year (and up to 5 years).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: This study is a single-blinded trial. Participants and health personnel at the clinic will not be blinded to group allocation, whereas researchers performing the analysis and the interpretation of the results will be blinded to group allocation. Once the study is completed, the data will be extracted from the database in anonymized form for statistical analyses, i.e. all personal information that may identify specific participants or group allocation will be removed and the intervention and control groups will be randomly labelled as A, B and C.
measure: Musculoskeletal Health Questionnaire (MSK-HQ)
time frame: Change from baseline to 3 months
description: The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.
measure: Pain-related disability for low back pain
time frame: Change from baseline to 3 months
description: Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.
measure: Pain-related disability for neck pain
time frame: Change from baseline to 3 months
description: Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.
measure: Average pain intensity
time frame: Change from baseline to 3 months
description: The average pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
measure: Worst pain intensity
time frame: Change from baseline to 3 months
description: The worst pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
measure: Health related quality of life
time frame: Change from baseline to 3 months
description: The EuroQoL 5-dimension (EQ-5D) questionnaire is used to assess health-related quality of life. 5 items scored 0 - 5 plus visual analogue scale scored 0- 100.
measure: Pain self-efficacy
time frame: Change from baseline to 3 months
description: The Pain Self-Efficacy Questionnaire (PSEQ) is used to assess participants' level of confidence in carrying out specific activities despite their pain. 10 items scored 0 - 6.
measure: Illness perception
time frame: Change from baseline to 3 months
description: The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.
measure: Fear avoidance belief
time frame: Change from baseline to 3 months
description: The Fear-Avoidance Belief Questionnaire (FABQ) - physical activity subscale is used to measure participant's beliefs about how physical activity affect their low back and/or neck pain. 5 items scored 0 - 6
measure: Stress symptoms
time frame: Change from baseline to 3 months
description: The Perceived Stress Scale (PSS) is used to evaluate stress levels. 10 items scored 0 - 4.
measure: Depressive symptoms
time frame: Change from baseline to 3 months
description: The Patient Health Questionnaire-2 (PHQ-2) is used to evaluate patients' depressive symptoms. 2 items scored 0 - 3.
measure: Functional change
time frame: Change from baseline to 3 months
description: The Patient Specific Functional Scale (PSFS) is used to evaluate changes in participant's ability to perform up to two self-selected activities regarded as important by them. Ability levels scored 0 - 10.
measure: Self-reported physical activity
time frame: Change from baseline to 3 months
description: The modernised Saltin-Grimby Physical Activity Level Scale is used to evaluate self-reported leisure time physical activity. 1 item (4 options).
measure: Self-reported sleep
time frame: Change from baseline to 3 months
description: Sleep problems are assessed by four self-report items which provide information needed to diagnose insomnia according to the DSM-V criteria. 4 items scored 0 - 2.
measure: Work ability
time frame: Change from baseline to 3 months
description: Work ability index (WAI) is used to assess work ability. 1-item rated on an 11-point numeric rating scale (0='completely unable to work' to 10='work ability at its best').
measure: Satisfaction with intervention
time frame: 3 months
description: Patient Acceptable Symptom State (PASS) is used to determine if patients consider themselves well and, as such, are satisfied with the treatment. 1 item (yes/no)
measure: Perceived effect
time frame: 3 months
description: Patient's Global Perceived Effect is used to investigate participants' perception of effect from the intervention they received. 1 item scored -5 to 5
measure: Health care consumption
time frame: 1 year
description: Objective registry based data linked to social security number in Norway are used to investigate health care consumption.
measure: Sickness absence
time frame: 1 year
description: Objective registry based data linked to social security number in Norway are used to investigate sickness absence.
arm group label: SelfBACK app
arm group type: Experimental
description: The selfBACK app in addition to usual care
arm group label: e-Help webpage
arm group type: Active Comparator
description: The e-Help webpage in addition to usual care
arm group label: Usual care
arm group type: Active Comparator
description: Usual care only
intervention type: Device
intervention name: SelfBACK app
description: The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
arm group label: SelfBACK app
intervention type: Other
intervention name: e-Help webpage
description: The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
arm group label: e-Help webpage
intervention type: Other
intervention name: Usual care
description: Usual care refers to seeking care or receiving treatments or help as usual.
arm group label: SelfBACK app
arm group label: Usual care
arm group label: e-Help webpage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Siri Forsmo, phd prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
citation: Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.
PMID: 34518253
responsible party type: Sponsor
mesh term: Neck Pain
sharing ipd: Yes
ipd description: Individual participant data will be available, including data dictionaries. Data available to share include individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Beginning 5 years after end of trial and ending 30 years after end of trial.
ipd access criteria: Investigators whose proposed use of the data has been approved by the national ethics committee. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement. Information regarding submitting proposals and accessing data may be found at (Link will be provided after completing the trial).