Digitally Delivered Treatments to Reduce Chronic Low Back Pain
NOTUS
NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
1 other identifier
interventional
720
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Jun 2025
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
June 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 26, 2028
July 20, 2025
May 1, 2025
2 years
May 14, 2025
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain intensity
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
Week 8 post-randomisation
Disability
Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.
Week 8 post-randomisation
Secondary Outcomes (8)
Pain intensity
Weeks 12, 26 and 52 post-randomisation
Disability
Weeks 12, 26 and 52 post-randomisation
Worst pain intensity
Weeks 8, 12, 26 and 52 post-randomisation
Adverse events
Week 8 post-randomisation
Health-related quality of life
Weeks 8, 12, 26 and 52 post-randomisation
- +3 more secondary outcomes
Other Outcomes (1)
Cost-utility analysis
From randomisation to week 52 post-randomisation
Study Arms (2)
Pain education and clinical hypnosis delivered via a mobile app
EXPERIMENTALPain education and clinical hypnosis for self-managing back pain, delivered via a mobile app.
Guideline-informed factsheet
ACTIVE COMPARATORA guideline-informed factsheet for back pain, delivered via a webpage.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuroscience Research Australia
Randwick, New South Wales, 2031, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James H McAuley, PhD
Neuroscience Research Australia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The statistician will be blinded to group allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 14, 2025
First Posted
May 22, 2025
Study Start
June 2, 2025
Primary Completion (Estimated)
May 26, 2027
Study Completion (Estimated)
May 26, 2028
Last Updated
July 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will be made available after the publication of the study reports. There is no end date for the availability of study data.
- Access Criteria
- Protocol and ethics must be provided.
De-identified individual participant data will be made available to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee. Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).