An interventional study of Usual care + selfBACK in Low Back Pain, sponsored by University of Southern Denmark. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: selfBACK digital decision support system
Roland Morris Disability Questionnaire
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.
Time frame: change from baseline to 6 weeks
Pain intensity
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.
Time frame: change from baseline to 6 weeks
The Fear avoidance Belief Questionnaire
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 \[completely agree\]
Time frame: change from baseline to 6 weeks
Pain Self-Efficacy Questionnaire
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 \[completely agree\].
Time frame: change from baseline to 6 weeks
Activity limitation
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".
Time frame: change from baseline to 6 weeks
Workability
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 \[work ability at its best\].
Time frame: change from baseline to 6 weeks
Saltin-Grimby Physical Activity Level Scale
Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active
Time frame: change from baseline to 6 weeks
Patient Specific Functional Scale
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
Time frame: change from baseline to 6 weeks
Sleep
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.
Time frame: change from baseline to 6 weeks
Perceived Stress Scale
a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress
Time frame: change from baseline to 6 weeks
Health-related Quality of Life
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).
Time frame: change from baseline to 6 weeks
Brief Illness Perception Questionnaire
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 \[worst severity\].
Time frame: change from baseline to 6 weeks
Patient Health Questionnaire-8
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.
Time frame: change from baseline to 6 weeks
Patients Global Perceived effect
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
Time frame: 6 weeks
Patient Acceptable Symptom State
a single item question on whether or not the patient considers their current symptom state as acceptable or not
Time frame: 6 weeks.
Virtual Care Climate Questionnaire
The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.
Time frame: 6 weeks
User ratings
Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system
Time frame: 6 weeks
Tailoring variables
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
Time frame: Weekly for 6 weeks
Physical activity
The patients' weekly recommended step count goal, and the actual achieved step count per. day
Time frame: weekly for 6 weeks
Exercise volume
The patients report back their completed exercise volume as number of set and repetitions for their suggested exercises, when they perform them
Time frame: weekly for 6 weeks
Plan to share: No
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Southern Denmark