Status:
COMPLETED
NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention
Lead Sponsor:
Neuroscience Research Australia
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- 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).
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06605248
Start Date
October 8 2024
End Date
March 13 2025
Last Update
May 22 2025
Active Locations (1)
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1
Neuroscience Research Australia
Randwick, New South Wales, Australia, 2031