Actively Recruiting
NOTUS Trial: Comparing Two Digital Treatments for Chronic Back Pain to Reduce Pain and Disability
Led by Neuroscience Research Australia · Updated on 2025-07-20
720
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two digitally delivered treatments to reduce pain and disability in people with chronic low back pain who visit general practitioners. The study compares pain education and clinical hypnosis delivered via a mobile app to a guideline-informed factsheet provided through a webpage. The goal is to see which approach better helps manage chronic low back pain symptoms. One group will use a mobile app for eight weeks, which includes daily sessions with five minutes of pain education, fifteen minutes of hypnotherapy audio, and five minutes of physical or social activities. The first six weeks follow a structured program with options to repeat sessions, while the last two weeks allow flexible, self-paced continuation. The other group receives a single factsheet online that provides reassurance and encourages self-management reflections. Participants will be involved for at least eight weeks post-randomization, during which pain intensity and disability will be measured. Additional assessments include pain, quality of life, anxiety, depression, and adverse events over 12, 26, and 52 weeks. Researchers will monitor app usage to track adherence. This helps understand the impact of the digital interventions on chronic low back pain over time.
CONDITIONS
Brief Title
Digitally Delivered Treatments to Reduce Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experiencing non-specific chronic low back pain between the 12th rib and buttock crease
- Low back pain may include leg pain but must be worse than leg pain if present
- Currently consulting a general practitioner for chronic low back pain in Australia
- Mean pain intensity score of 3 or higher on the Numeric Rating Scale in the past week
- At least moderate physical functioning score on question 8 of the SF-36 questionnaire
- Access to a mobile device able to download a 300MB app
- Internet connection to use the mobile app features
- Able to understand English through reading and audio materials
You will not qualify if you...
- Known or suspected specific spinal problems like radiculopathy or fracture
- Known or suspected non-spinal serious conditions such as tumor or infection
- Less than six months since spinal surgery
- Scheduled for major surgery during the program or follow-up
- Untreated serious psychiatric condition affecting trial participation
- Sight or hearing problems limiting ability to access app's reading or audio
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 8 weeks
Participants receive an 8-week behavioral intervention to manage chronic low back pain. One group uses a mobile app delivering pain education and clinical hypnosis with daily sessions, while the other group receives a guideline-informed factsheet via a webpage.
Daily sessions via mobile app or webpage
Duration - Up to 44 weeks after treatment
Participants are monitored for pain intensity, disability, and other health outcomes up to 52 weeks after treatment completion.
Assessments at Weeks 12, 26, and 52 post-randomisation
Trial Site Locations
Total: 1 location
1
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031
Actively Recruiting
Research Team
J
James H McAuley, PhD
R
Rodrigo RN Rizzo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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