Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06984354
Registration number
NCT06984354
Ethics application status
Date submitted
14/05/2025
Date registered
22/05/2025
Date last updated
25/05/2025
Titles & IDs
Public title
Digitally Delivered Treatments to Reduce Chronic Low Back Pain
Query!
Scientific title
NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
Query!
Secondary ID [1]
0
0
iRECS4383
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
NOTUS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Low Back Pain
0
0
Query!
Chronic Pain (Back / Neck)
0
0
Query!
General Practice (GP), Primary Care Settings
0
0
Query!
Digital Health
0
0
Query!
Hypnosis, Chronic Pain Management
0
0
Query!
Patient Education
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
BEHAVIORAL - Pain education and clinical hypnosis delivered via a mobile app
BEHAVIORAL - Guideline-informed factsheet
Experimental: Pain education and clinical hypnosis delivered via a mobile app - Pain education and clinical hypnosis for self-managing back pain, delivered via a mobile app.
Active comparator: Guideline-informed factsheet - A guideline-informed factsheet for back pain, delivered via a webpage.
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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Pain intensity
Query!
Assessment method [1]
0
0
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
Query!
Timepoint [1]
0
0
Week 8 post-randomisation
Query!
Primary outcome [2]
0
0
Disability
Query!
Assessment method [2]
0
0
Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.
Query!
Timepoint [2]
0
0
Week 8 post-randomisation
Query!
Secondary outcome [1]
0
0
Pain intensity
Query!
Assessment method [1]
0
0
Average pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).
Query!
Timepoint [1]
0
0
Weeks 12, 26 and 52 post-randomisation
Query!
Secondary outcome [2]
0
0
Disability
Query!
Assessment method [2]
0
0
Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.
Query!
Timepoint [2]
0
0
Weeks 12, 26 and 52 post-randomisation
Query!
Secondary outcome [3]
0
0
Worst pain intensity
Query!
Assessment method [3]
0
0
Worst pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).
Query!
Timepoint [3]
0
0
Weeks 8, 12, 26 and 52 post-randomisation
Query!
Secondary outcome [4]
0
0
Adverse events
Query!
Assessment method [4]
0
0
Adverse events will be assessed using self-reported information during the trial.
Query!
Timepoint [4]
0
0
Week 8 post-randomisation
Query!
Secondary outcome [5]
0
0
Health-related quality of life
Query!
Assessment method [5]
0
0
Health-related quality of life will be measured using the EuroQol 5-Dimensions 5-Level (EQ-5D-5L) questionnaire, which includes an index score ranging from 0 to 1 and a health visual analogue scale (VAS) ranging from 0 to 100, with higher scores indicating a better health state.
Query!
Timepoint [5]
0
0
Weeks 8, 12, 26 and 52 post-randomisation
Query!
Secondary outcome [6]
0
0
Global impression of change
Query!
Assessment method [6]
0
0
Global impression of change measured by the Global Perceived Effect Scale using the following questions: 'With respect to your low back pain, how would you describe yourself now compared to when you started the treatment program?' (range, -5 to 5; lower scores indicate worse outcomes).
Query!
Timepoint [6]
0
0
Weeks 8, 12, 26 and 52 post-randomisation
Query!
Secondary outcome [7]
0
0
Anxiety symptoms
Query!
Assessment method [7]
0
0
Anxiety symptoms will be measured by the anxiety sub-scale from the Depression, Anxiety, Stress Scale (DASS-21), scores ranging from 0 to 42, with higher scores indicating worse symptoms.
Query!
Timepoint [7]
0
0
Weeks 8, 12, 26 and 52 post-randomisation
Query!
Secondary outcome [8]
0
0
Depression symptoms
Query!
Assessment method [8]
0
0
Depression symptoms will be measured by the depression sub-scale from the Depression, Anxiety, Stress Scale (DASS-21), scores ranging from 0 to 42, with higher scores indicating worse symptoms.
Query!
Timepoint [8]
0
0
Weeks 8, 12, 26 and 52 post-randomisation
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
26/05/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
26/05/2028
Query!
Actual
Query!
Sample size
Target
720
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Neuroscience Research Australia - Randwick
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Neuroscience Research Australia
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06984354
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
James H McAuley, PhD
Query!
Address
0
0
Neuroscience Research Australia
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
James H McAuley, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61293991266
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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 (
[email protected]
).
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Analytic code
Query!
When will data be available (start and end dates)?
Data will be made available after the publication of the study reports. There is no end date for the availability of study data.
Query!
Available to whom?
Protocol and ethics must be provided.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06984354
Download to PDF