Mobile app delivering pain education and clinical hypnosis for chronic low back pain
Official title: NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
Run by Neuroscience Research Australia · NCT06984354 · Data updated 2026-11-12
This study will test whether a mobile app that provides pain education and clinical hypnosis can reduce pain and disability in people with non-specific chronic low back pain who are seeing a GP in Australia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 720 (estimated) |
| Sponsor | Neuroscience Research Australia Academic / other |
| Locations | 1 site (Randwick, New South Wales) |
| Status | Recruiting |
| Started | June 2, 2025 |
| Main results expected | May 26, 2027 |
| Study ends | May 26, 2028 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT06984354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults in Australia with non-specific chronic low back pain (average pain ≥3/10) who are currently consulting a GP, have at least moderate physical functioning impairment, and can use a smartphone with internet access.
✕Probably not a fit
People with known specific spinal or non-spinal pathology (e.g., radiculopathy, fracture, tumour, infection), those less than six months post-spinal surgery or scheduled for major surgery, or those without a compatible mobile device or English proficiency are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with non-specific chronic low back pain who are currently consulting a general practitioner are invited to participate. Participants are allocated to receive either a mobile app combining pain education and clinical hypnosis or a guideline-informed factsheet. The app delivers audio hypnosis sessions and educational modules and requires a compatible mobile device and internet access. Outcomes focus on changes in pain intensity and physical disability over the intervention and follow-up periods to compare the two approaches.
Why it matters
Potential benefit: If effective, the app could provide an accessible, low-cost way to reduce pain and improve function for people with chronic low back pain.
How similar studies have gone: Prior digital pain-education and app-based self-management studies have shown modest improvements in chronic pain and function, while digitally delivered clinical hypnosis has more limited but promising early evidence.
Who can join: the full rules
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. 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 it's running
-
Neuroscience Research Australia
Randwick, New South Wales, Australia Recruiting
Study contacts
- Principal investigator: James H McAuley, PhD — Neuroscience Research Australia
- Study coordinator: James H McAuley, PhD
- Email: j.mcauley@neura.edu.au
- Phone: +61293991266
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.