The purpose of this study is to evaluate the effectiveness of an individually tailored self-management intervention, the selfBACK app, in improving health status in patients on a waiting list for outpatient rehabilitation due to low back and/or neck pain compared to a non-tailored web-based self-management solution (e-Help) and usual care only.
Patients on waiting list for treatment at the multidisciplinary outpatient clinic for back, neck and shoulder rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway, due to low back and/or neck pain are the target group for this study. The average waiting time for receiving treatment is 8-10 weeks. The use of digital solutions can be a beneficial approach to support self-management during the waiting period. Therefore, the effectiveness of these tools in this patients group needs to be evaluated. A total of 279 participants will be recruited and randomly allocated to one of the three groups: 1) the selfBACK app in addition to usual care; 2) the e-Help webpage in addition to usual care; and 3) usual care only. Participants who receive either the selfBACK app and the e-Help webpage will be allowed to seek care, treatment or help elsewhere as usual. Self-reported outcome measures will be collected through web-based questionnaires at three follow-up time points: 1) 6 weeks; 2) 3 months (primary endpoint); and 3) 6 months. In addition, participants receiving the selfBACK app will be asked a set of weekly tailoring questions to individualize self-management plans. Objective registry based data linked to social security number in Norway will be used to investigate health care consumption and sickness absence at 1 year (and up to 5 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
294
The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
Usual care refers to seeking care or receiving treatments or help as usual.
Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital
Trondheim, Norway
Musculoskeletal Health Questionnaire (MSK-HQ)
The MSK-HQ is used to measure musculoskeletal health status. The MSK-HQ contains 14 items scored from 0 to 4. The final score ranges from 0 to 56 (sum of all items), with higher scores indicating better musculoskeletal health status.
Time frame: Change from baseline to 3 months
Pain-related disability for low back pain
Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.
Time frame: Change from baseline to 3 months
Pain-related disability for neck pain
Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.
Time frame: Change from baseline to 3 months
Average pain intensity
The average pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
Time frame: Change from baseline to 3 months
Worst pain intensity
The worst pain intensity within the past week is measured by a 11-point numerical rating scale (NRS) ranging from 0='no pain' to 10='worst pain imaginable'.
Time frame: Change from baseline to 3 months
Health related quality of life
The EuroQoL 5-dimension (EQ-5D) questionnaire is used to assess health-related quality of life. 5 items scored 0 - 5 plus visual analogue scale scored 0- 100.
Time frame: Change from baseline to 3 months
Pain self-efficacy
The Pain Self-Efficacy Questionnaire (PSEQ) is used to assess participants' level of confidence in carrying out specific activities despite their pain. 10 items scored 0 - 6.
Time frame: Change from baseline to 3 months
Illness perception
The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.
Time frame: Change from baseline to 3 months
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