Low Back PainNOTUSNCT06984354
Digitally Delivered Treatments to Reduce Chronic Low Back Pain
A study testing Pain education and clinical hypnosis delivered via a mobile app and Guideline-informed factsheet in people with Low Back Pain and Chronic Pain (Back / Neck), run by Neuroscience Research Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Chronic Pain (Back / Neck), General Practice (GP), Primary Care Settings
- What is being tested?
- Pain education and clinical hypnosis delivered via a mobile app and Guideline-informed factsheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Jun 2025to 26 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Neuroscience Research Australia
Randwick, New South Wales, 2031
James H McAuley, PhD, +61293991266, j.mcauley@neura.edu.au
About this study
Official title: NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
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.
- Conditions
- Low Back Pain, Chronic Pain (Back / Neck), General Practice (GP), Primary Care Settings, Digital Health, Hypnosis, Chronic Pain Management, Patient Education
- Being tested
- Pain education and clinical hypnosis delivered via a mobile app, Guideline-informed factsheet
- Keywords
- Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
- Medical subject headings
- Low Back Pain, Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain education and clinical hypnosis delivered via a mobile appBehavioural
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.
Guideline-informed factsheetBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain education and clinical hypnosis delivered via a mobile app | Experimental | Pain education and clinical hypnosis for self-managing back pain, delivered via a mobile app. Receives: Behavioral: Pain education and clinical hypnosis delivered via a mobile app |
| Guideline-informed factsheet | Active comparator | A guideline-informed factsheet for back pain, delivered via a webpage. Receives: Behavioral: Guideline-informed factsheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
Measured: Week 8 post-randomisation
Disability
Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.
Measured: Week 8 post-randomisation
Secondary outcomes (8)
Pain intensity
Average pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).
Measured: Weeks 12, 26 and 52 post-randomisation
Disability
Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.
Measured: Weeks 12, 26 and 52 post-randomisation
Worst pain intensity
Worst pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).
Measured: Weeks 8, 12, 26 and 52 post-randomisation
Adverse events
Adverse events will be assessed using self-reported information during the trial.
Measured: Week 8 post-randomisation
Health-related quality of life
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.
Measured: Weeks 8, 12, 26 and 52 post-randomisation
Global impression of change
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).
Measured: Weeks 8, 12, 26 and 52 post-randomisation
Anxiety symptoms
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.
Measured: Weeks 8, 12, 26 and 52 post-randomisation
Depression symptoms
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.
Measured: Weeks 8, 12, 26 and 52 post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start2 Jun 2025
- Primary completion26 May 2027 (estimated)
- Study completion26 May 2028 (estimated)
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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroscience Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James McAuley, Neuroscience Research Australia
- Investigators
- James H McAuley, PhD, Principal investigator, Neuroscience Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984354
- Sponsor's protocol ID
- iRECS4383
- Acronym
- NOTUS
- Status last verified
- Aug 2026
- First submitted
- 14 May 2025
- Last updated
- 14 Aug 2026
- 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 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 (j.mcauley@neura.edu.au).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
- ClinicalTrials.gov ID
- NCT06984354
- Acronym / sponsor ID
- NOTUS / iRECS4383
- Conditions
- Low Back Pain, Chronic Pain (Back / Neck), General Practice (GP), Primary Care Settings, Digital Health, Hypnosis, Chronic Pain Management, Patient Education
- Keywords
- Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Neuroscience Research AustraliaUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 22 May 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain education and clinical hypnosis delivered via a mobile app | Experimental | Behavioral: Pain education and clinical hypnosis delivered via a mobile appPain education and clinical hypnosis for self-managing back pain, delivered via a mobile app. |
| Guideline-informed factsheet | Active comparator | Behavioral: Guideline-informed factsheetA guideline-informed factsheet for back pain, delivered via a webpage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Pain education and clinical hypnosis delivered via a mobile appPain 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. | Behavioural | Pain education and clinical hypnosis delivered via a mobile app |
| Guideline-informed factsheetA 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. | Behavioural | Guideline-informed factsheet |
Primary outcome
Pain intensity
Time frame: Week 8 post-randomisation
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
Disability
Time frame: Week 8 post-randomisation
Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.
8 secondary outcomes
Pain intensity
Time frame: Weeks 12, 26 and 52 post-randomisation
Disability
Time frame: Weeks 12, 26 and 52 post-randomisation
Worst pain intensity
Time frame: Weeks 8, 12, 26 and 52 post-randomisation
Adverse events
Time frame: Week 8 post-randomisation
Health-related quality of life
Time frame: Weeks 8, 12, 26 and 52 post-randomisation
Global impression of change
Time frame: Weeks 8, 12, 26 and 52 post-randomisation
Anxiety symptoms
Time frame: Weeks 8, 12, 26 and 52 post-randomisation
Depression symptoms
Time frame: Weeks 8, 12, 26 and 52 post-randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. 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 (j.mcauley@neura.edu.au).
Related trials for Low Back Pain
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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.
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 testing Pain education and clinical hypnosis delivered via a mobile app and Guideline-informed factsheet in people with Low Back Pain and Chronic Pain (Back / Neck), 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 8 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James H McAuley, PhD (+61293991266, j.mcauley@neura.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Week 8 post-randomisation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.