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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Usual care + selfBACK

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Digital Decision Support System, App, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Usual care + selfBACK

Arm Description

Participants will use the selfBACK system and app

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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]

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].

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".

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].

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

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

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.

Perceived Stress Scale

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

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).

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].

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.

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

Patient Acceptable Symptom State

a single item question on whether or not the patient considers their current symptom state as acceptable or not

Virtual Care Climate Questionnaire

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

User ratings

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

Full Information

NCT ID

NCT03697759

First Posted

August 10, 2018

Last Updated

February 27, 2019

Sponsor

University of Southern Denmark

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03697759

Brief Title

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

Acronym

selfBACK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 20, 2018 (Actual)

Primary Completion Date

February 5, 2019 (Actual)

Study Completion Date

February 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Southern Denmark

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Digital Decision Support System, App, Self-management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual care + selfBACK

Arm Type

Experimental

Arm Description

Participants will use the selfBACK system and app

Intervention Type

Other

Intervention Name(s)

Usual care + selfBACK

Other Intervention Name(s)

selfBACK digital decision support system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Roland Morris Disability Questionnaire

Description

Time Frame