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

NCT04463043 | Completed

• 1 other identifier: 64084
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Neck Pain

Keywords

self-management; rehabilitation; mHealth; eHealth

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 3 months

Secondary Outcomes (7)

• Pain-related disability for low back pain

  Change from baseline to 3 months

• Pain-related disability for neck pain

  Change from baseline to 3 months

• Average pain intensity

  Change from baseline to 3 months

• Worst pain intensity

  Change from baseline to 3 months

• Health related quality of life

  Change from baseline to 3 months

Other Outcomes (11)

• Fear avoidance belief

  Change from baseline to 3 months

• Stress symptoms

  Change from baseline to 3 months

• Depressive symptoms

  Change from baseline to 3 months

Study Arms (3)

SelfBACK app

EXPERIMENTAL

The selfBACK app in addition to usual care

Device: SelfBACK app; Other: Usual care

e-Help webpage

ACTIVE COMPARATOR

The e-Help webpage in addition to usual care

Other: e-Help webpage; Other: Usual care

Usual care

ACTIVE COMPARATOR

Usual care only

Other: Usual care

Interventions

SelfBACK app DEVICE

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.

SelfBACK app

e-Help webpage OTHER

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.

e-Help webpage

Usual care OTHER

Usual care refers to seeking care or receiving treatments or help as usual.

SelfBACK app; Usual care; e-Help webpage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Tverrfaglig poliklinikk rygg/nakke/skulder, St. Olavs Hospital

Trondheim, Norway

Location

Related Publications (3)

• 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.

  PMID: 34518253 BACKGROUND

• Marcuzzi A, Klevanger NE, Aasdahl L, Gismervik S, Bach K, Mork PJ, Nordstoga AL. An Artificial Intelligence-Based App for Self-Management of Low Back and Neck Pain in Specialist Care: Process Evaluation From a Randomized Clinical Trial. JMIR Hum Factors. 2024 Jul 9;11:e55716. doi: 10.2196/55716.

  PMID: 38980710 DERIVED

• Marcuzzi A, Nordstoga AL, Bach K, Aasdahl L, Nilsen TIL, Bardal EM, Boldermo NO, Falkener Bertheussen G, Marchand GH, Gismervik S, Mork PJ. Effect of an Artificial Intelligence-Based Self-Management App on Musculoskeletal Health in Patients With Neck and/or Low Back Pain Referred to Specialist Care: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2320400. doi: 10.1001/jamanetworkopen.2023.20400.

  PMID: 37368401 DERIVED

MeSH Terms

Conditions

Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siri Forsmo, phd prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is a single-blinded trial. Participants and health personnel at the clinic will not be blinded to group allocation, whereas researchers performing the analysis and the interpretation of the results will be blinded to group allocation. Once the study is completed, the data will be extracted from the database in anonymized form for statistical analyses, i.e. all personal information that may identify specific participants or group allocation will be removed and the intervention and control groups will be randomly labelled as A, B and C.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 9, 2020
• Study Start: July 9, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 3, 2021
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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).

Locations

NO (1)