Low Back PainselfBACKNCT03697759
A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
A study of Low Back Pain, run by University of Southern Denmark at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Aug 2018to 17 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, 5230
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Usual care + selfBACK
- Keywords
- Digital Decision Support System, App, Self-management
- Medical subject headings
- Low Back Pain, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual care + selfBACKOther
Also called selfBACK digital decision support system
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care + selfBACK | Experimental | Participants will use the selfBACK system and app Receives: Other: Usual care + selfBACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 6 weeks
Secondary outcomes (16)
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.
Measured: 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]
Measured: 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].
Measured: 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".
Measured: 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].
Measured: 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
Measured: 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
Measured: 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.
Measured: change from baseline to 6 weeks
Perceived Stress Scale
a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress
Measured: 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).
Measured: 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].
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 weeks.
Virtual Care Climate Questionnaire
The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.
Measured: 6 weeks
User ratings
Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start20 Aug 2018
- Primary completion5 Feb 2019
- Study completion17 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, National Research Centre for the Working Environment, Denmark, University of Glasgow, Robert Gordon University
- Responsible party
- Sponsor
- Investigators
- Karen Søgaard, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697759
- Sponsor's protocol ID
- S-20182000-24
- Other IDs
- 2018/791
- Acronym
- selfBACK
- Status last verified
- Oct 2018
- First submitted
- 10 Aug 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Sandal LF, Overas CK, Nordstoga AL, Wood K, Bach K, Hartvigsen J, Sogaard K, Mork PJ. A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020.
PubMed 32489674
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
- ClinicalTrials.gov ID
- NCT03697759
- Acronym / sponsor ID
- selfBACK / S-20182000-24
- Conditions
- Low Back Pain
- Keywords
- Digital Decision Support System, App, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, National Research Centre for the Working Environment, Denmark, University of Glasgow, Robert Gordon University
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 17 Feb 2019 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual care + selfBACK | Experimental | Other: Usual care + selfBACKParticipants will use the selfBACK system and app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual care + selfBACKAlso: selfBACK digital decision support systemThe 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 | Usual care + selfBACK |
Primary outcome
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.
16 secondary outcomes
Pain intensity
Time frame: change from baseline to 6 weeks
The Fear avoidance Belief Questionnaire
Time frame: change from baseline to 6 weeks
Pain Self-Efficacy Questionnaire
Time frame: change from baseline to 6 weeks
Activity limitation
Time frame: change from baseline to 6 weeks
Workability
Time frame: change from baseline to 6 weeks
Saltin-Grimby Physical Activity Level Scale
Time frame: change from baseline to 6 weeks
Patient Specific Functional Scale
Time frame: change from baseline to 6 weeks
Sleep
Time frame: change from baseline to 6 weeks
Perceived Stress Scale
Time frame: change from baseline to 6 weeks
Health-related Quality of Life
Time frame: change from baseline to 6 weeks
Brief Illness Perception Questionnaire
Time frame: change from baseline to 6 weeks
Patient Health Questionnaire-8
Time frame: change from baseline to 6 weeks
Patients Global Perceived effect
Time frame: 6 weeks
Patient Acceptable Symptom State
Time frame: 6 weeks.
Virtual Care Climate Questionnaire
Time frame: 6 weeks
User ratings
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- BackgroundBach 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
- Derived from this study: PubMed 32489674Sandal LF, Overas CK, Nordstoga AL, Wood K, Bach K, Hartvigsen J, Sogaard K, Mork PJ. A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020.
- project webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Søgaard, PhD principal investigator
University of Southern Denmark
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Low Back Pain, run by University of Southern Denmark at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Questionnaire (time frame: change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03697759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.