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Completed

NCT Number: NCT03798288

Randomised Controlled Trial for the selfBACK Project

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 (LBP) via an smartphone app.

Completed

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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 decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.

The weekly plan includes three categories of content;

  • information/education
  • recommended daily number of steps
  • recommended strength and flexibility exercises

Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

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 (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
  • LBP of any duration
  • Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
  • 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 understand the national language (Danish/ Norwegian),
  • Cognitive impairments or learning disabilities limiting participation,
  • Mental or physical illness or condition limiting participation,
  • Inability to take part in exercise/physical activity,
  • Fibromyalgia (diagnosed by a health care professional),
  • Pregnancy,
  • Previous back surgery
  • Ongoing participation in other research trials for LBP management.

Treatment and study plan

selfBACK

Behavioral

Participants will use the selfBACK system and app in addition to receiving usual care

Usual Care

Other

Participants will receive usual care

Primary outcomes

  1. Roland Morris Disability Questionnaire

    Time frame: change from baseline to 3 months

    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 Self-Efficacy Questionnaire

    Time frame: change from baseline to 3 months

    The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree].

  2. The Fear Avoidance Belief Questionnaire

    Time frame: change from baseline to 3 months

    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 intensity

    Time frame: change from baseline to 3 months

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

  4. Brief Illness Perception Questionnaire

    Time frame: change from baseline to 3 months

    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].

  5. Saltin-Grimby Physical Activity Level Scale

    Time frame: change from baseline to 3 months

    Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active

  6. Patients Global Perceived Effect

    Time frame: 3 months

    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

Other outcomes

  1. Workability

    Time frame: change from baseline to 3 months

    Workability 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].

  2. Health-related Quality of Life

    Time frame: change from baseline to 3 months

    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).

  3. Activity limitation

    Time frame: change from baseline to 3 months

    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".

  4. Sleep

    Time frame: change from baseline to 3 months

    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.

  5. Perceived Stress Scale

    Time frame: change from baseline to 3 months

    a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress

  6. Patient Health Questionnaire-8

    Time frame: change from baseline to 3 months

    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.

  7. Patient Specific Functional Scale

    Time frame: change from baseline to 3 months

    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. Pain duration and frequency

    Time frame: change from baseline to 3 months

    Pain duration measures patients' self-reported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for LBP.

  9. Virtual Care Climate Questionnaire

    Time frame: 4 months

    The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.

  10. User ratings

    Time frame: 4 months

    Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system

  11. Tailoring variables

    Time frame: weekly for 9 months

    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 lob back pain (NRS for pain intensity), function, fear-avoidance, workability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management.

    Note. not all questions are asked on a weekly basis

  12. Physical activity

    Time frame: weekly for 9 months

    The patients' weekly recommended step count goal, and the actual achieved step count per. day

  13. Exercise volume

    Time frame: weekly for 9 months

    The patients report back their completed exercise volume as number of sets 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

Official study title

A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project

Acronym: selfBACK

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2019
Registry last updated
Feb 17, 2023

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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