An interventional study of SelfBACK app and e-Help webpage in Back Pain and Neck Pain, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment
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).
2,389 studies on the registry are indexed under Back Pain; 282 are open to participants now.
This study's enrollment of 294 is above the median of 60 across 1,952 interventional studies indexed under Back Pain.
Browse Back Pain studies →Norwegian University of Science and Technology is the lead sponsor of 494 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The selfBACK app in addition to usual care
Device: SelfBACK app · Other: Usual care
The e-Help webpage in addition to usual care
Other: e-Help webpage · Other: Usual care
Usual care only
Other: Usual care
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.
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
Fear avoidance belief
The Fear-Avoidance Belief Questionnaire (FABQ) - physical activity subscale is used to measure participant's beliefs about how physical activity affect their low back and/or neck pain. 5 items scored 0 - 6
Time frame: Change from baseline to 3 months
Stress symptoms
The Perceived Stress Scale (PSS) is used to evaluate stress levels. 10 items scored 0 - 4.
Time frame: Change from baseline to 3 months
Depressive symptoms
The Patient Health Questionnaire-2 (PHQ-2) is used to evaluate patients' depressive symptoms. 2 items scored 0 - 3.
Time frame: Change from baseline to 3 months
Functional change
The Patient Specific Functional Scale (PSFS) is used to evaluate changes in participant's ability to perform up to two self-selected activities regarded as important by them. Ability levels scored 0 - 10.
Time frame: Change from baseline to 3 months
Self-reported physical activity
The modernised Saltin-Grimby Physical Activity Level Scale is used to evaluate self-reported leisure time physical activity. 1 item (4 options).
Time frame: Change from baseline to 3 months
Self-reported sleep
Sleep problems are assessed by four self-report items which provide information needed to diagnose insomnia according to the DSM-V criteria. 4 items scored 0 - 2.
Time frame: Change from baseline to 3 months
Work ability
Work ability index (WAI) is used to assess work ability. 1-item rated on an 11-point numeric rating scale (0='completely unable to work' to 10='work ability at its best').
Time frame: Change from baseline to 3 months
Satisfaction with intervention
Patient Acceptable Symptom State (PASS) is used to determine if patients consider themselves well and, as such, are satisfied with the treatment. 1 item (yes/no)
Time frame: 3 months
Perceived effect
Patient's Global Perceived Effect is used to investigate participants' perception of effect from the intervention they received. 1 item scored -5 to 5
Time frame: 3 months
Health care consumption
Objective registry based data linked to social security number in Norway are used to investigate health care consumption.
Time frame: 1 year
Sickness absence
Objective registry based data linked to social security number in Norway are used to investigate sickness absence.
Time frame: 1 year
Plan to share: Yes — Individual participant data will be available, including data dictionaries. Data available to share include individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 5 years after end of trial and ending 30 years after end of trial.
Access criteria: Investigators whose proposed use of the data has been approved by the national ethics committee. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement. Information regarding submitting proposals and accessing data may be found at (Link will be provided after completing the trial).
Ran from Jul 2020 to primary completion in Aug 2021, 12 months.
Of 933 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 12 months is above that.
Counting every sponsor, half of 997 studies reached it within 11 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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