RecruitingNot ApplicableNCT06984354

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

Sponsor

Neuroscience Research Australia

Enrollment

720 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria5

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).

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Interventions

BEHAVIORALPain 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.

BEHAVIORALGuideline-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.