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Randomised Controlled Trial for the selfBACK Project (selfBACK)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
selfBACK
Usual care
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

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 (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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual care + selfBACK

Usual care

Arm Description

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

Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal.

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 Self-Efficacy Questionnaire
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].
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 intensity
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.
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].
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
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

Full Information

First Posted
January 7, 2019
Last Updated
February 14, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT03798288
Brief Title
Randomised Controlled Trial for the selfBACK Project
Acronym
selfBACK
Official Title
A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
October 20, 2020 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 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.

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
Parallel Assignment
Model Description
The study design is a multi-center randomised controlled trial with 2 parallel arms
Masking
Investigator
Masking Description
The analysis of the data will be performed blindly.
Allocation
Randomized
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care + selfBACK
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal.
Intervention Type
Behavioral
Intervention Name(s)
selfBACK
Intervention Description
Participants will use the selfBACK system and app in addition to receiving usual care
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants will receive usual care
Primary Outcome Measure Information:
Title
Roland Morris Disability Questionnaire
Description
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 3 months
Secondary Outcome Measure Information:
Title
Pain Self-Efficacy Questionnaire
Description
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].
Time Frame
change from baseline to 3 months
Title
The Fear Avoidance Belief Questionnaire
Description
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 3 months
Title
Pain intensity
Description
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.
Time Frame
change from baseline to 3 months
Title
Brief Illness Perception Questionnaire
Description
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 3 months
Title
Saltin-Grimby Physical Activity Level Scale
Description
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 3 months
Title
Patients Global Perceived Effect
Description
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
3 months
Other Pre-specified Outcome Measures:
Title
Workability
Description
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].
Time Frame
change from baseline to 3 months
Title
Health-related Quality of Life
Description
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 3 months
Title
Activity limitation
Description
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 3 months
Title
Sleep
Description
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 3 months
Title
Perceived Stress Scale
Description
a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress
Time Frame
change from baseline to 3 months
Title
Patient Health Questionnaire-8
Description
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 3 months
Title
Patient Specific Functional Scale
Description
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 3 months
Title
Pain duration and frequency
Description
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.
Time Frame
change from baseline to 3 months
Title
Virtual Care Climate Questionnaire
Description
The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.
Time Frame
4 months
Title
User ratings
Description
Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system
Time Frame
4 months
Title
Tailoring variables
Description
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
Time Frame
weekly for 9 months
Title
Physical activity
Description
The patients' weekly recommended step count goal, and the actual achieved step count per. day
Time Frame
weekly for 9 months
Title
Exercise volume
Description
The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them
Time Frame
weekly for 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Søgaard, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
City
Odense
ZIP/Postal Code
5230
Country
Denmark
Facility Name
Norwegian University of Science and Technology
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30030208
Citation
Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379. Erratum In: JMIR Res Protoc. 2019 Jan 03;8(1):e12180.
Results Reference
background
PubMed Identifier
35130898
Citation
Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z.
Results Reference
derived
PubMed Identifier
34338710
Citation
Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097.
Results Reference
derived
PubMed Identifier
33118959
Citation
Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308.
Results Reference
derived
PubMed Identifier
31793897
Citation
Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720.
Results Reference
derived
Links:
URL
http://www.selfback.eu
Description
project webpage

Learn more about this trial

Randomised Controlled Trial for the selfBACK Project

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