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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
Date last updated
22/05/2025
Titles & IDs
Public title
NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention
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Scientific title
NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management With Mobile App-based Pain Education and Clinical Hypnosis in Primary Care
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Secondary ID [1]
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X23-0202 & 2023/ETH00540
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Low Back Pain
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Individuals meeting the preliminary eligibility criteria
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Assessment method [1]
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Proportion of individuals meeting the preliminary eligibility criteria in the pre-consultation tool BetterConsult and who agreed to receive a digital intervention as part of the study, compared to all eligible individuals reporting back pain as the primary health issue in the BetterConsult tool (data from BetterConsult).
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Timepoint [1]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [2]
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General practitioners who agreed to prescribe a digital intervention
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Assessment method [2]
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Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult).
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Timepoint [2]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [3]
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Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
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Assessment method [3]
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Proportion of individuals who received the Participant Information Form and shared their name, phone number, and email to be contacted by the research group (data from the research group) compared to those who met the preliminary eligibility criteria and whose general practitioners agreed to prescribe a digital intervention as part of the trial (data from BetterConsult).
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Timepoint [3]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [4]
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Individuals who completed the full eligibility criteria compared to those who shared their details
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Assessment method [4]
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Proportion of individuals who completed the full eligibility criteria for the study compared to those who shared their details after receiving the Participant Consent Form (data from the research group).
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Timepoint [4]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [5]
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Number of individuals who provided consent to participate
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Assessment method [5]
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Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap).
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Timepoint [5]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [6]
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Number of individuals who provided consent for the research group to collect MBS and PBS data.
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Assessment method [6]
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Number of individuals who provided consent for the research group to collect Medicare Benefits Scheme and Pharmaceutical Benefits Scheme data (collected by the research group via REDCap).
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Timepoint [6]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [7]
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Proportion of individuals who completed the baseline questionnaires
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Assessment method [7]
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Proportion of individuals who completed the socio-demographic baseline questions compared to all individuals who consented to participate in the feasibility study (data from the research group).
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Timepoint [7]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [8]
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Recruitment rate per day, week or month.
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Assessment method [8]
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Number of individuals randomised in a given day, week or month (collected by the research group via REDCap)
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Timepoint [8]
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From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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Primary outcome [9]
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The Acceptability of Intervention Measure
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Assessment method [9]
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The Acceptability of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher scores indicate greater acceptability.
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Timepoint [9]
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Baseline and 8 week follow-up
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Primary outcome [10]
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The Appropriateness of Intervention Measure
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Assessment method [10]
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The Appropriateness of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher score indicates a higher level of appropriateness.
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Timepoint [10]
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Baseline and 8 week follow-up
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Primary outcome [11]
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Completion rate of questionnaires
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Assessment method [11]
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The completion rate of questionnaires at baseline and the eight-week follow-up include: 0 to 10 numeric rating scale average pain and worst pain intensity, 0 to 24 Ronald Morris Disability Questionnaire and DASS-21 (depression, anxiety and stress sub-scales), higher scores indicate worse outcomes. Acceptability of Intervention Measure and Intervention Appropriateness Measure (1 to 5, higher scores indicate better outcomes) The completion rate of questionnaires at the 8-week follow-up include: -5 to 5 Global Perceived Effect Scale, 0 to 1 EuroQol 5 dimensions questionnaire, 0 to 12 Short-Form Pain Self-Efficacy Questionnaire, 0 to 100 Credibility/Expectancy Questionnaire (expectancy sub-scale) and 1 to 5 Mobile App Rating Satisfaction Sub-Scale, higher scores indicate better outcomes. 0 to 28 Short-Form Pain Catastrophising Scale, 9 to 45 Back Beliefs Questionnaire, 11 to 44 Short-Form Tampa Scale for Kinesiophobia, higher scores indicate worse outcomes.
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Timepoint [11]
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Baseline and 8 week follow-up
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Primary outcome [12]
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Adherence to the digital intervention
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Assessment method [12]
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The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health).
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Timepoint [12]
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Throughout the intervention to the 8 week follow-up
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Primary outcome [13]
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Mobile App Rating Satisfaction Sub-Scale
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Assessment method [13]
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We will assess satisfaction sub-scale using two questions from the Mobile App Rating Scale. Each item ranges from 1 to 5 (higher score indicates a greater level of satisfaction).
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Timepoint [13]
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8 week follow-up
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Primary outcome [14]
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Participants experience through semi-structured interview
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Assessment method [14]
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Qualitative study on participants experience in the feasibility study (with at least 6 participants).
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Timepoint [14]
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8 week follow-up
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Primary outcome [15]
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Adverse events
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Assessment method [15]
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Assessed by self-reported information
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Timepoint [15]
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8 week follow-up
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Primary outcome [16]
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Participants experience with the intervention
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Assessment method [16]
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This study will qualitatively investigate the participants experience with three open-ended questions. These questions include: 1. What have you learned or experienced that has been the most helpful to you? 2. How do you see yourself applying the intervention to your daily life in the long term? 3. What else could we do to help you incorporate the intervention into your daily life?
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Timepoint [16]
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8-week follow-up
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/10/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/03/2025
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Sample size
Target
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Accrual to date
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Final
60
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This feasibility study will investigate the feasibility of screening, recruiting, and delivering a mobile app intervention that involves pain education and clinical hypnosis to people seeking treatments for chronic low back pain (chronic LBP) in general practices in Australia. This study aims to assess the recruitment strategy, the willingness of participants to be included in the proposed treatments, whether the intervention can be delivered as intended within the health care system and clinical setting, the adherence of participants to the proposed treatment, response rates to questionnaires, loss to the short-term follow-up, and the appropriateness and acceptability of the interventions. This feasibility study will inform possible modifications in the recruitment and treatments for the main clinical trial. A total of 60 participants will be randomised into two treatment groups.
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Trial website
https://clinicaltrials.gov/study/NCT06605248
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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James H McAuley, PhD
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Address
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Neuroscience Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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James H James H McAuley, PhD
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Address
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Country
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Phone
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+61293991266
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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
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