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.
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.
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.
Parallel
Pain education and clinical hypnosis delivered via a mobile app
BehavioralPain 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
BehavioralA 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.
Pain intensity
Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)
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.
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).
Disability
Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.
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).
Adverse events
Adverse events will be assessed using self-reported information during the trial.
Cost-utility analysis
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.
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