Mobile app delivering pain education and clinical hypnosis for chronic low back pain

NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain

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

• Phase: NA
• Study type: Interventional
• Enrollment: 720 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Neuroscience Research Australia (other)
• Locations: 1 site (Randwick, New South Wales)
• Trial ID: NCT06984354 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Randwick, New South Wales

• 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

Conditions: Low Back Pain, Chronic Pain, General Practice, Primary Care Settings, Digital Health, Hypnosis, Chronic Pain Management, Patient Education, Back Pain, Hypnosis