Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment720 (estimated)
SponsorNeuroscience Research Australia
Academic / other
Locations1 site (Randwick, New South Wales)
StatusRecruiting
StartedJune 2, 2025
Main results expectedMay 26, 2027
Study endsMay 26, 2028
Registry record updatedAugust 14, 2026
Trial IDNCT06984354 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.