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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06605248




Registration number
NCT06605248
Ethics application status
Date submitted
10/09/2024
Date registered
20/09/2024

Titles & IDs
Public title
NOTUS Feasibility Study: Reducing Chronic Low Back Pain with Mobile App Intervention
Scientific title
NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management with Mobile App-based Pain Education and Clinical Hypnosis in Primary Care
Secondary ID [1] 0 0
X23-0202 & 2023/ETH00540
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 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 - App-based self-management tool plus usual care
BEHAVIORAL - Patient information digital fact-sheet plus usual care

Experimental: App-based self-management tool plus usual care - App-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care.

Experimental: Patient information digital fact-sheet plus usual care - The intervention consists of a fact-sheet delivered after usual care.


BEHAVIORAL: App-based self-management tool plus usual care
The app-based self-management tool will be delivered after patients receive usual care from their general practitioners. The 8-week mobile app intervention will involve daily sessions on pain education and clinical hypnosis for back pain management (5 minutes, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes.

BEHAVIORAL: Patient information digital fact-sheet plus usual care
The face-sheet will be delivered after patients receive usual care from their general practitioners.This digital intervention will contain educational material for chronic back pain that includes details about diagnosis, prognosis and treatment options.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Individuals meeting the preliminary eligibility criteria
Timepoint [1] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [2] 0 0
General practitioners who agreed to prescribe a digital intervention
Timepoint [2] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [3] 0 0
Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
Timepoint [3] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [4] 0 0
Individuals who completed the full eligibility criteria compared to those who shared their details
Timepoint [4] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [5] 0 0
Number of individuals who provided consent to participate
Timepoint [5] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [6] 0 0
Number of individuals who provided consent for the research group to collect MBS and PBS data.
Timepoint [6] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [7] 0 0
Proportion of individuals who completed the baseline questionnaires
Timepoint [7] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [8] 0 0
Recruitment rate per day, week or month.
Timepoint [8] 0 0
From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Primary outcome [9] 0 0
The Acceptability of Intervention Measure
Timepoint [9] 0 0
Baseline and 8 week follow-up
Primary outcome [10] 0 0
The Appropriateness of Intervention Measure
Timepoint [10] 0 0
Baseline and 8 week follow-up
Primary outcome [11] 0 0
Completion rate of questionnaires
Timepoint [11] 0 0
Baseline and 8 week follow-up
Primary outcome [12] 0 0
Adherence to the digital intervention
Timepoint [12] 0 0
Throughout the intervention to the 8 week follow-up
Primary outcome [13] 0 0
Mobile App Rating Satisfaction Sub-Scale
Timepoint [13] 0 0
8 week follow-up
Primary outcome [14] 0 0
Participants experience through semi-structured interview
Timepoint [14] 0 0
8 week follow-up
Primary outcome [15] 0 0
Adverse events
Timepoint [15] 0 0
8 week follow-up
Primary outcome [16] 0 0
Participants experience with the intervention
Timepoint [16] 0 0
8-week follow-up

Eligibility
Key inclusion criteria
* Experiencing chronic LBP, defined as pain in the area between the 12th rib and buttock crease accompanied or not by leg pain for a minimum duration of 12 weeks.
* LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
* Currently attending general practice across Australia.
* Mean pain intensity score on the NRS = 3/10 in the past week.
* A score of at least moderate on question 8 of the physical functioning component of the SF36 questionnaire.
* Access to a mobile device with minimal requirements to download the study app (300MB).
* Internet connection to access the mobile app functionalities.
* Able to understand English via reading and audio materials.
* Individuals who reported interest in participating in a clinical trial involving digital interventions after consultation with their general practitioners.
* Individuals whose general practitioners permitted them to receive information about the trial after the general practice consultation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected back-specific (e.g., radiculopathy, fracture) or non-back-specific (e.g., tumour, infection) serious spinal 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 the 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
24/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
60
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 James H McAuley, PhD
Address 0 0
Country 0 0
Phone 0 0
+61293991266
Fax 0 0
Email 0 0
j.mcauley@neura.edu.au
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 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).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Data will be made available after the publication of 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/NCT06605248