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Completed

NCT Number: NCT03697759

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

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.

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Key information

Conditions

Low Back Pain Alzheimer Disease Back Pain Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual care + selfBACK

Other

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 names: selfBACK digital decision support system

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • National Research Centre for the Working Environment, Denmark
  • Norwegian University of Science and Technology
  • Robert Gordon University
  • University of Glasgow

Registry information

Acronym: selfBACK

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2018
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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