Randomised Controlled Trial for the selfBACK Project (selfBACK)

A Decision Support System for Self-management of Low Back Pain - a Randomized 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: selfBACK; Other: Usual care

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;

1. information/education
2. recommended daily number of steps
3. recommended strength and flexibility exercises

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

• Study Type: Interventional
• Enrollment (Actual): 461
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5230
    • Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
• Norway
  • Trondheim, Norway
    • Norwegian University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual care + selfBACK; 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	Behavioral: selfBACK; Participants will use the selfBACK system and app in addition to receiving usual care; Other: Usual care; Participants will receive usual care
Active Comparator: Usual care; 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.	Other: Usual care; Participants will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	change from baseline to 3 months
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]	change from baseline to 3 months
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.	change from baseline to 3 months
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].	change from baseline to 3 months
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	change from baseline to 3 months
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	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Workability	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].	change from baseline to 3 months
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).	change from baseline to 3 months
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".	change from baseline to 3 months
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.	change from baseline to 3 months
Perceived Stress Scale	a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress	change from baseline to 3 months
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.	change from baseline to 3 months
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	change from baseline to 3 months
Pain duration and frequency	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.	change from baseline to 3 months
Virtual Care Climate Questionnaire	The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.	4 months
User ratings	Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system	4 months
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 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	weekly for 9 months
Physical activity	The patients' weekly recommended step count goal, and the actual achieved step count per. day	weekly for 9 months
Exercise volume	The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them	weekly for 9 months

Collaborators and Investigators

• 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: App; Self-management; Digital Decision Support System
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 18/17955CDJ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No