Clinical trial NCT06984354: Digitally Delivered Treatments to Reduce Chronic Low Back Pain
Official title: NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Neuroscience Research Australia
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Pain intensity
timeFrame: Week 8 post-randomisation
measure: Disability
timeFrame: Week 8 post-randomisation
Secondary outcomes:
measure: Pain intensity
timeFrame: Weeks 12, 26 and 52 post-randomisation
measure: Disability
timeFrame: Weeks 12, 26 and 52 post-randomisation
measure: Worst pain intensity
timeFrame: Weeks 8, 12, 26 and 52 post-randomisation
measure: Adverse events
timeFrame: Week 8 post-randomisation
measure: Health-related quality of life
timeFrame: Weeks 8, 12, 26 and 52 post-randomisation
measure: Global impression of change
timeFrame: Weeks 8, 12, 26 and 52 post-randomisation
measure: Anxiety symptoms
timeFrame: Weeks 8, 12, 26 and 52 post-randomisation
measure: Depression symptoms
timeFrame: Weeks 8, 12, 26 and 52 post-randomisation
Other outcomes:
measure: Cost-utility analysis
timeFrame: From randomisation to week 52 post-randomisation
Locations:
city: Randwick
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: Neuroscience Research Australia
name: James H McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References: