Improving use of a mobile app for chronic low back pain
Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)
This will test whether phone calls or text messages help people with chronic low back pain use a pain-management app more than the app's standard notifications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuroscience Research Australia Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT07205991 on ClinicalTrials.gov |
What this trial studies
Adults with non-specific chronic low back pain will use a mobile app that delivers pain education and clinical hypnosis. Participants are randomized to receive up to two phone calls, up to two text messages, or only the app's standard push notifications to encourage app use. The main outcome is app adherence measured through usage metrics captured by the app. Recruitment is conducted via the NOTUS trial with coordination at Neuroscience Research Australia in Sydney.
Who should consider this trial
Good fit: Ideal candidates are adults in Australia with non-specific chronic low back pain (average pain ≥3/10) who are consulting a GP, can read English, and have a smartphone and internet access.
Not a fit: Patients with specific spinal pathology (for example radiculopathy, fracture, tumour or infection), those less than six months post-spinal surgery, people without a compatible mobile device or internet, or individuals not enrolled via the NOTUS trial are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could help people stick with an app-based pain program longer, which may improve their self-management and symptoms.
How similar studies have performed: Text-message reminders and brief phone calls have improved engagement in some digital health programs, but evidence specifically for app adherence in chronic low back pain is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease. * LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain). * Currently consulting with a general practitioner for their non-specific chronic LBP across Australia. * Mean pain intensity score on the Numeric Rating Scale ≥ 3/10 in the past week. * A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire. * Access to a mobile device with minimal requirements to download the study app (300MB). * An internet connection to access the mobile app functionalities. * Able to understand English via reading and audio materials. * Randomised to experimental group at NOTUS Trial. Exclusion Criteria: * Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology. * Less than six months post-spinal surgery. * Scheduled for major surgery during the program or the follow-up period. * Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities. * Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).
Where this trial is running
Sydney, New South Wales
- Neuroscience Research Australia — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: James H McAuley, PhD
- Email: j.mcauley@neura.edu.au
- Phone: +61293991266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.