NCT06984354

Digitally Delivered Treatments to Reduce Chronic Low Back Pain

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Neuroscience Research Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Conditions

• Low Back Pain
• Chronic Pain (Back / Neck)
• General Practice (GP), Primary Care Settings
• Digital Health
• Hypnosis, Chronic Pain Management
• Patient Education

Interventions

Type	Name	Description
BEHAVIORAL	Pain education and clinical hypnosis delivered via a mobile app	Pain education and clinical hypnosis will be delivered via a mobile app. The 8-week intervention includes daily sessions on pain education and clinical hypnosis for managing back pain (5 minutes of education, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes). The first six weeks will be semi-standardised, with participants following a set program with the option to repeat sessions. The last two weeks will be flexible, allowing participants to choose a specific program or self-paced continuation of the intervention. Adherence will be monitored by tracking the number of days participants complete sessions, as recorded by the mobile app.
BEHAVIORAL	Guideline-informed factsheet	A single guideline-informed factsheet for back pain delivered via a webpage. Participants will be informed that the factsheet intends to provide reassurance for their back pain and encourage reflections on treatments and self-management options.

Timeline

• Start date: 2025-06-02
• Primary completion: 2027-05-26
• Completion: 2028-05-26
• First posted: 2025-05-22
• Last updated: 2025-07-20

Locations

1 site across 1 country: Australia