Randomised Controlled Trial for the selfBACK Project (selfBACK)

• ClinicalTrials.gov Identifier: NCT03798288
• Recruitment Status: Completed
• First Posted: January 9, 2019
• Last Update Posted: February 17, 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
• Information provided by (Responsible Party): University of Southern Denmark

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain	Behavioral: selfBACK; Other: Usual care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 461 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study design is a multi-center randomised controlled trial with 2 parallel arms
• Masking: Single (Investigator)
• Masking Description: The analysis of the data will be performed blindly.
• Primary Purpose: Treatment
• Official Title: A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project
• Actual Study Start Date: March 8, 2019
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: October 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Roland Morris Disability Questionnaire [ Time Frame: change from baseline to 3 months ]
   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 :

1. Pain Self-Efficacy Questionnaire [ Time Frame: change from baseline to 3 months ]
   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].
2. The Fear Avoidance Belief Questionnaire [ Time Frame: change from baseline to 3 months ]
   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]
3. Pain intensity [ Time Frame: change from baseline to 3 months ]
   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.
4. Brief Illness Perception Questionnaire [ Time Frame: change from baseline to 3 months ]
   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].
5. Saltin-Grimby Physical Activity Level Scale [ Time Frame: change from baseline to 3 months ]
   Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active
6. Patients Global Perceived Effect [ Time Frame: 3 months ]
   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

Other Outcome Measures:

1. Workability [ Time Frame: change from baseline to 3 months ]
   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].
2. Health-related Quality of Life [ Time Frame: change from baseline to 3 months ]
   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).
3. Activity limitation [ Time Frame: change from baseline to 3 months ]
   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".
4. Sleep [ Time Frame: change from baseline to 3 months ]
   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.
5. Perceived Stress Scale [ Time Frame: change from baseline to 3 months ]
   a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress
6. Patient Health Questionnaire-8 [ Time Frame: change from baseline to 3 months ]
   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.
7. Patient Specific Functional Scale [ Time Frame: change from baseline to 3 months ]
   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
8. Pain duration and frequency [ Time Frame: change from baseline to 3 months ]
   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.
9. Virtual Care Climate Questionnaire [ Time Frame: 4 months ]
   The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.
10. User ratings [ Time Frame: 4 months ]
    Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system
11. Tailoring variables [ Time Frame: weekly for 9 months ]

    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

12. Physical activity [ Time Frame: weekly for 9 months ]
    The patients' weekly recommended step count goal, and the actual achieved step count per. day
13. Exercise volume [ Time Frame: weekly for 9 months ]
    The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Denmark

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

Odense, Denmark, 5230

Norway

Norwegian University of Science and Technology

Trondheim, Norway

Sponsors and Collaborators

University of Southern Denmark

Norwegian University of Science and Technology

National Research Centre for the Working Environment, Denmark

University of Glasgow

Robert Gordon University

Investigators

• Principal Investigator: Karen Søgaard, PhD; University of Southern Denmark

  Study Documents (Full-Text)

Documents provided by University of Southern Denmark:

Study Protocol  [PDF] February 20, 2019

Statistical Analysis Plan  [PDF] February 8, 2023

More Information

Additional Information:

project webpage 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT03798288
• Other Study ID Numbers: 18/17955CDJ
• First Posted: January 9, 2019
• Last Update Posted: February 17, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Southern Denmark:

Digital Decision Support System; App; Self-management

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations