Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06984354

Digitally Delivered Treatments to Reduce Chronic Low 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Low Back Pain Back Pain Chronic Pain Chronic Pain (Back / Neck) Digital Health General Practice (GP), Primary Care Settings Hypnosis, Chronic Pain Management Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Education Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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).

Treatment and study plan

Pain education and clinical hypnosis delivered via a mobile app

Behavioral

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 factsheet

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Pain intensity

    Time frame: Weeks 12, 26 and 52 post-randomisation

    Average pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).

  2. Disability

    Time frame: Weeks 12, 26 and 52 post-randomisation

    Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.

  3. Worst pain intensity

    Time frame: Weeks 8, 12, 26 and 52 post-randomisation

    Worst pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).

  4. Adverse events

    Time frame: Week 8 post-randomisation

    Adverse events will be assessed using self-reported information during the trial.

  5. Health-related quality of life

    Time frame: Weeks 8, 12, 26 and 52 post-randomisation

    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.

  6. Global impression of change

    Time frame: Weeks 8, 12, 26 and 52 post-randomisation

    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).

  7. Anxiety symptoms

    Time frame: Weeks 8, 12, 26 and 52 post-randomisation

    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.

  8. Depression symptoms

    Time frame: Weeks 8, 12, 26 and 52 post-randomisation

    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.

Other outcomes

  1. Cost-utility analysis

    Time frame: From randomisation to week 52 post-randomisation

    The cost-utility of the intervention will be evaluated by calculating quality-adjusted life years using the EuroQOL EQ-5D-5L measure. The total cost of delivering the intervention within the trial will be calculated, along with total healthcare consumption external to the trial, using data from the Medicare and Pharmaceutical Benefits Scheme databases and self-reports.

Study contacts

Contact information is provided by the study sponsor or research team.

James H McAuley, PhD

CONTACT

[email protected]

+61293991266

Rodrigo RN Rizzo, PhD

CONTACT

[email protected]

(02) 9399 1000

Sponsors and collaborators

Lead sponsor

Neuroscience Research Australia

Other

Registry information

Official study title

NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain

Acronym: NOTUS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 22, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.