Clinical trial NCT04463043: An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation
Official title: The Effectiveness of an App-based (selfBACK) Versus a Web-based (e-Help) Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation: a Three Arm Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Neck Pain
Keywords: self-management
rehabilitation
mHealth
eHealth
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2020-07-09
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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 pain and/or neck pain
* Own and use a smartphone with internet access to download the mobile application
* Able to provide informed consent

Exclusion Criteria:

* Less than 4 weeks waiting time until scheduled appointment at clinic (i.e., patients prioritized for urgent treatment/examination)
* Unable to take part in exercise/physical activity, e.g. non-ambulatory patients, use of walking aids, unable to get up and down the floor independently
* Unable to speak and/or read Norwegian
* Unable to complete the baseline questionnaire

Primary outcomes:
measure: Musculoskeletal Health Questionnaire (MSK-HQ)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Pain-related disability for low back pain
timeFrame: Change from baseline to 3 months
measure: Pain-related disability for neck pain
timeFrame: Change from baseline to 3 months
measure: Average pain intensity
timeFrame: Change from baseline to 3 months
measure: Worst pain intensity
timeFrame: Change from baseline to 3 months
measure: Health related quality of life
timeFrame: Change from baseline to 3 months
measure: Pain self-efficacy
timeFrame: Change from baseline to 3 months
measure: Illness perception
timeFrame: Change from baseline to 3 months
Other outcomes:
measure: Fear avoidance belief
timeFrame: Change from baseline to 3 months
measure: Stress symptoms
timeFrame: Change from baseline to 3 months
measure: Depressive symptoms
timeFrame: Change from baseline to 3 months
measure: Functional change
timeFrame: Change from baseline to 3 months
measure: Self-reported physical activity
timeFrame: Change from baseline to 3 months
measure: Self-reported sleep
timeFrame: Change from baseline to 3 months
measure: Work ability
timeFrame: Change from baseline to 3 months
measure: Satisfaction with intervention
timeFrame: 3 months
measure: Perceived effect
timeFrame: 3 months
measure: Health care consumption
timeFrame: 1 year
measure: Sickness absence
timeFrame: 1 year
Locations:
city: Trondheim
country: Norway
facility: Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, phd prof
role: STUDY_DIRECTOR
References:
citation: Marcuzzi A, Bach K, Nordstoga AL, Bertheussen GF, Ashikhmin I, Boldermo NO, Kvarner EN, Nilsen TIL, Marchand GH, Ose SO, Aasdahl L, Kaspersen SL, Bardal EM, Borke JB, Mork PJ, Gismervik S. Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial. BMJ Open. 2021 Sep 13;11(9):e047921. doi: 10.1136/bmjopen-2020-047921.