NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention

A study of Low Back Pain, run by Neuroscience Research Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteAustralia
Study dates: 8 Oct 2024to 13 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Show all 10Show fewer

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Australia1 site

Neuroscience Research Australia
Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management With Mobile App-based Pain Education and Clinical Hypnosis in Primary Care

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.

Conditions: Low Back Pain
Being tested: App-based self-management tool plus usual care, Patient information digital fact-sheet plus usual care
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

App-based self-management tool plus usual careBehavioural
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.
Patient information digital fact-sheet plus usual careBehavioural
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.

Study groups in NCT06605248
Study group	Role	What they receive
App-based self-management tool plus usual care	Experimental	App-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care. Receives: Behavioral: App-based self-management tool plus usual care
Patient information digital fact-sheet plus usual care	Experimental	The intervention consists of a fact-sheet delivered after usual care. Receives: Behavioral: Patient information digital fact-sheet plus usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

Individuals meeting the preliminary eligibility criteria
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).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
General practitioners who agreed to prescribe a digital intervention
Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
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).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Individuals who completed the full eligibility criteria compared to those who shared their details
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).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals who provided consent to participate
Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals who provided consent for the research group to collect MBS and PBS data.
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).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of individuals who completed the baseline questionnaires
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).
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Recruitment rate per day, week or month.
Number of individuals randomised in a given day, week or month (collected by the research group via REDCap)
Measured: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
The Acceptability of Intervention Measure
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.
Measured: Baseline and 8 week follow-up
The Appropriateness of Intervention Measure
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.
Measured: Baseline and 8 week follow-up
Completion rate of questionnaires
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.
Measured: Baseline and 8 week follow-up
Adherence to the digital intervention
The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health).
Measured: Throughout the intervention to the 8 week follow-up
Mobile App Rating Satisfaction Sub-Scale
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).
Measured: 8 week follow-up
Participants experience through semi-structured interview
Qualitative study on participants experience in the feasibility study (with at least 6 participants).
Measured: 8 week follow-up
Adverse events
Assessed by self-reported information
Measured: 8 week follow-up
Participants experience with the intervention
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?
Measured: 8-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202413 Mar 2025

First posted20 Sep 2024
Study start8 Oct 2024
Primary completion13 Mar 2025
Study completion13 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06605248
Sponsor's protocol ID: X23-0202 & 2023/ETH00540
Status last verified: May 2025
First submitted: 10 Sep 2024
Last updated: 22 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
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Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
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Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
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Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management With Mobile App-based Pain Education and Clinical Hypnosis in Primary Care
ClinicalTrials.gov ID: NCT06605248
Acronym / sponsor ID: X23-0202 & 2023/ETH00540
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Neuroscience Research AustraliaUniversity, hospital or other
Study start: 8 Oct 2024 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 20 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A total of 60 participants will be randomised into two treatment groups.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
App-based self-management tool plus usual care	Experimental	Behavioral: App-based self-management tool plus usual careApp-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care.
Patient information digital fact-sheet plus usual care	Experimental	Behavioral: Patient information digital fact-sheet plus usual careThe intervention consists of a fact-sheet delivered after usual care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
App-based self-management tool plus usual careThe 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.	Behavioural	App-based self-management tool plus usual care
Patient information digital fact-sheet plus usual careThe 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.	Behavioural	Patient information digital fact-sheet plus usual care

Primary outcome

Individuals meeting the preliminary eligibility criteria
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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).
General practitioners who agreed to prescribe a digital intervention
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult).
Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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).
Individuals who completed the full eligibility criteria compared to those who shared their details
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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).
Number of individuals who provided consent to participate
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap).
Number of individuals who provided consent for the research group to collect MBS and PBS data.
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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).
Proportion of individuals who completed the baseline questionnaires
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
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).
Recruitment rate per day, week or month.
Time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals randomised in a given day, week or month (collected by the research group via REDCap)
The Acceptability of Intervention Measure
Time frame: Baseline and 8 week follow-up
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.
The Appropriateness of Intervention Measure
Time frame: Baseline and 8 week follow-up
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.
Completion rate of questionnaires
Time frame: Baseline and 8 week follow-up
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.
Adherence to the digital intervention
Time frame: Throughout the intervention to the 8 week follow-up
The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health).
Mobile App Rating Satisfaction Sub-Scale
Time frame: 8 week follow-up
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).
Participants experience through semi-structured interview
Time frame: 8 week follow-up
Qualitative study on participants experience in the feasibility study (with at least 6 participants).
Adverse events
Time frame: 8 week follow-up
Assessed by self-reported information
Participants experience with the intervention
Time frame: 8-week follow-up
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?

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Individual participant dataSharing planned: Yes. 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).

Related trials for Low Back Pain

Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James H McAuley, PhD principal investigator

Neuroscience Research Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Low Back Pain, run by Neuroscience Research Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Individuals meeting the preliminary eligibility criteria (time frame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.