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A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY (selfBACK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697759
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Norwegian University of Science and Technology
National Research Centre for the Working Environment, Denmark
University of Glasgow
Robert Gordon University
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

The pilot study precedes a larger randomized controlled trial, to be starting in February 2019.

In this pilot study all participants are allocated to the intervention group.

The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain. The plan is presented to the participant in the selfBACK app.


Condition or disease Intervention/treatment Phase
Low Back Pain Other: Usual care + selfBACK Not Applicable

Detailed Description:

The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain.

The SELFBACK system constitutes a data-driven predictive decision support system that uses Case-Based Reasoning methodology to capture and reuse participant cases in order to suggest the most suitable self-management plan for participants. The selfBACK system is an intelligent system that will adjust the suggested self-management plan to the individual participants by using the information available on the participant (baseline questionnaires), weekly self-reported of changes in health status through the app, and data on physical activity via the step-detecting wristband.

The weekly plan includes three categories of content; 1) information/education, 2) physical activity monitoring through wearing a step-detecting wristband, and 3) strength and flexibility exercises.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
Masking: None (Open Label)
Masking Description: Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.
Primary Purpose: Treatment
Official Title: A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Usual care + selfBACK
Participants will use the selfBACK system and app
Other: Usual care + selfBACK

The selfBACK intervention is a digital Decision Support System (DSS) for self-management of LBP provided to the participant via a smartphone app (selfBACK app). In addition, the participant is provided with a step-detecting wristband (Xiaomi Mi Band 2) that interacts with the selfBACK app.

The DSS provides individually tailored self-management plans including content from three categories; 1) information/education, 2) physical activity monitoring through wearing the step-detecting wristband, and 3) strength and flexibility exercises. The weekly plans are individually tailored to the specific patient, using the data available from the patient, and each week the patients report back their progress on physical activity (step count) and exercise (volume completed). These data are matched with the patients follow-up data to create a self-management plan that is up to date and adaptable to variation in health-status of the individual patient.

Other Name: selfBACK digital decision support system




Primary Outcome Measures :
  1. Roland Morris Disability Questionnaire [ Time Frame: change from baseline to 6 weeks ]
    The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability.


Secondary Outcome Measures :
  1. Pain intensity [ Time Frame: change from baseline to 6 weeks ]

    Pain intensity measured as average and worst within the past week. Measured on a 0 - 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable.

    Pain duration measures patients' selfreported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for low back pain.


  2. The Fear avoidance Belief Questionnaire [ Time Frame: change from baseline to 6 weeks ]
    The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree]

  3. Pain Self-Efficacy Questionnaire [ Time Frame: change from baseline to 6 weeks ]
    The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain [52, 53]. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree].

  4. Activity limitation [ Time Frame: change from baseline to 6 weeks ]
    Activity Limitation evaluates if LBP has limited work and leisure time activities. The questionnaire consists of two single items with response options "yes" and "no".

  5. Workability [ Time Frame: change from baseline to 6 weeks ]
    Work Ability is measured by a single-item and rated on an 11-point NRS scale ranging from zero [completely unable to work] to 10 [work ability at its best].

  6. Saltin-Grimby Physical Activity Level Scale [ Time Frame: change from baseline to 6 weeks ]
    Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active

  7. Patient Specific Functional Scale [ Time Frame: change from baseline to 6 weeks ]
    Participants rate their function on up to two self-selected activities, are asked to rate if they are unable to do or are having difficulty with the their ability to perform self-selected activities regarded as important by the participants themselves

  8. Sleep [ Time Frame: change from baseline to 6 weeks ]
    Sleep is assessed by self-report using four items concerning problems with falling asleep, waking up repeatedly, waking up too early, and feeling sleepy during the day.

  9. Perceived Stress Scale [ Time Frame: change from baseline to 6 weeks ]
    a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress

  10. Health-related Quality of Life [ Time Frame: change from baseline to 6 weeks ]
    The EuroQoL 5-dimension (EQ-5D) questionnaire is used to asses quality of life within each of the five dimension (i.e., mobility, self-care, activities, pain/discomfort and anxiety/depression).

  11. Brief Illness Perception Questionnaire [ Time Frame: change from baseline to 6 weeks ]
    the questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity].

  12. Patient Health Questionnaire-8 [ Time Frame: change from baseline to 6 weeks ]
    the questionnaire is an 8-item questionnaire used to evaluate the participants' depressive symptoms. Items are scored on a 4-point Likert scale scoring frequency of experiencing symptoms of depression.

  13. Patients Global Perceived effect [ Time Frame: 6 weeks ]
    a single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention

  14. Patient Acceptable Symptom State [ Time Frame: 6 weeks. ]
    a single item question on whether or not the patient considers their current symptom state as acceptable or not

  15. Virtual Care Climate Questionnaire [ Time Frame: 6 weeks ]
    The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.

  16. User ratings [ Time Frame: 6 weeks ]
    Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system


Other Outcome Measures:
  1. Tailoring variables [ Time Frame: Weekly for 6 weeks ]

    Participants in the intervention are on a weekly basis asked a set of tailoring questions. These are tracked over the intervention period. The tailoring questions include items on pain (NRS for pain intensity), function, fear-avoidance, work ability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management.

    Note. not all questions are asked on a weekly basis


  2. Physical activity [ Time Frame: weekly for 6 weeks ]
    The patients' weekly recommended step count goal, and the actual achieved step count per. day

  3. Exercise volume [ Time Frame: weekly for 6 weeks ]
    The patients report back their completed exercise volume as number of set and repetitions for their suggested exercises, when they perform them



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seeking care from primary health-care practice or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks
  • LBP of any duration
  • Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale.
  • Age: ≥18 years
  • Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
  • Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

Exclusion Criteria:

  • Not interested
  • Unable to speak, read or write in the national language (Danish/ Norwegian)
  • Cognitive impairment or learning disabilities
  • Pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution)
  • Serious mental illness, such as major depression, schizophrenia, and psychosis
  • Terminal illness
  • Unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently)
  • Fibromyalgia (diagnosed by a Health Care Professional)
  • Pregnancy
  • Previous back surgery
  • Ongoing participation in other research trials for LBP management

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697759


Locations
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Denmark
Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, Denmark, 5230
Norway
Norwegian University of Science and Techonology
Trondheim, Norway
Sponsors and Collaborators
University of Southern Denmark
Norwegian University of Science and Technology
National Research Centre for the Working Environment, Denmark
University of Glasgow
Robert Gordon University
Investigators
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Principal Investigator: Karen Søgaard, PhD University of Southern Denmark

Additional Information:
Publications:
Bach K, Szczepanski T, Aamodt A, Gundersen OE, Mork. PJ. Case Representation and Similarity Assessment in the selfBACK Decision Support System ICCBR 2016: Case-Based Reasoning Research and Development pp 32-46

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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03697759    
Other Study ID Numbers: S-20182000-24
2018/791 ( Other Identifier: The Regional Committee for Medicine and Health Related Research Ethics )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Digital Decision Support System
App
Self-management
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms