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

Norwegian University of Science and Technology

Status: Completed

Conditions: Back Pain; Neck Pain

Treatments: Device: SelfBACK app; Other: e-Help webpage; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04463043

64084

Details and patient eligibility

About

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.

Full 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).

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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294 participants in 3 patient groups

SelfBACK app

Experimental group

Description:

The selfBACK app in addition to usual care

Treatment:

Device: SelfBACK app

Other: Usual care

e-Help webpage

Active Comparator group

Description:

The e-Help webpage in addition to usual care

Treatment:

Other: e-Help webpage

Other: Usual care

Usual care

Active Comparator group

Description:

Usual care only

Treatment:

Other: Usual care