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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
22/05/2025

Titles & IDs
Public title
Digitally Delivered Treatments to Reduce Chronic Low Back Pain: Randomised Controlled Trial
Scientific title
NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
Secondary ID [1] 0 0
iRECS4383
Universal Trial Number (UTN)
Trial acronym
NOTUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Chronic Pain (Back / Neck) 0 0
General Practice (GP), Primary Care Settings 0 0
Digital Health 0 0
Hypnosis, Chronic Pain Management 0 0
Patient Education 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Week 8 post-randomisation
Primary outcome [2] 0 0
Disability
Timepoint [2] 0 0
Week 8 post-randomisation
Secondary outcome [1] 0 0
Pain intensity
Timepoint [1] 0 0
Weeks 12, 26 and 52 post-randomisation
Secondary outcome [2] 0 0
Disability
Timepoint [2] 0 0
Weeks 12, 26 and 52 post-randomisation
Secondary outcome [3] 0 0
Worst pain intensity
Timepoint [3] 0 0
Weeks 8, 12, 26 and 52 post-randomisation
Secondary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
Week 8 post-randomisation
Secondary outcome [5] 0 0
Health-related quality of life
Timepoint [5] 0 0
Weeks 8, 12, 26 and 52 post-randomisation
Secondary outcome [6] 0 0
Global impression of change
Timepoint [6] 0 0
Weeks 8, 12, 26 and 52 post-randomisation
Secondary outcome [7] 0 0
Anxiety symptoms
Timepoint [7] 0 0
Weeks 8, 12, 26 and 52 post-randomisation
Secondary outcome [8] 0 0
Depression symptoms
Timepoint [8] 0 0
Weeks 8, 12, 26 and 52 post-randomisation

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/05/2028
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James H McAuley, PhD
Address 0 0
Neuroscience Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James H McAuley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61293991266
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
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.
Available to whom?
Protocol and ethics must be provided.
Available for what types of analyses?
How or where can data be obtained?


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