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

Not Applicable

Completed

• Conditions: Back Pain; Neck Pain
• Interventions: Device: SelfBACK app; Other: e-Help webpage; Other: Usual care

• Registration Number: NCT04463043
• Lead Sponsor: Norwegian University of Science and Technology

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).

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-07-03
• Study Start: 2020-07-09
• Study First Posted: 2020-07-09
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SelfBACK app	Usual care	The selfBACK app in addition to usual care
Usual care	Usual care	Usual care only
SelfBACK app	SelfBACK app	The selfBACK app in addition to usual care
e-Help webpage	e-Help webpage	The e-Help webpage in addition to usual care
e-Help webpage	Usual care	The e-Help webpage in addition to usual care

Primary Outcome Measures

Name	Time	Method
Musculoskeletal Health Questionnaire (MSK-HQ)	Change from baseline to 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Pain-related disability for low back pain	Change from baseline to 3 months	Pain-related disability is measured by the Roland Morris Disability Questionnaire (RMDQ) ranging from 0 to 24. Higher scores indicate higher pain-related disability.
Pain-related disability for neck pain	Change from baseline to 3 months	Pain-related disability is measured by the Neck Disability Index (NDI) ranging from 0 to 50. Higher scores indicate higher pain-related disability.
Average pain intensity	Change from baseline to 3 months	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'.
Worst pain intensity	Change from baseline to 3 months	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'.
Health related quality of life	Change from baseline to 3 months	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.
Pain self-efficacy	Change from baseline to 3 months	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.
Illness perception	Change from baseline to 3 months	The Brief Illness Perception Questionnaire (BIPQ) is used to evaluate participants' illness perception. 8 items scored 0 - 10.

Trial Locations

Locations (1)

Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital; 🇳🇴 Trondheim, Norway