Chronic Pain (Back / Neck), Digital Health, General Practice (GP), Primary Care Settings, Hypnosis, Chronic Pain Management, Low Back Pain, Patient Education
Conditions
Keywords
Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
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.
Interventions
BEHAVIORALPain education and clinical hypnosis delivered via a mobile app
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.
BEHAVIORALGuideline-informed factsheet
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.
Sponsors
Neuroscience Research Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statistician will be blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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) |
| Disability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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). |
| Disability | 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. |
| Worst pain intensity | 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). |
| Adverse events | Week 8 post-randomisation | Adverse events will be assessed using self-reported information during the trial. |
| Health-related quality of life | 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. |
| Global impression of change | 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). |
| Anxiety symptoms | 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. |
| Depression symptoms | 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. |
Countries
Australia
Contacts
CONTACTJames H McAuley, PhD
CONTACTRodrigo RN Rizzo, PhD
PRINCIPAL_INVESTIGATORJames H McAuley, PhD
Neuroscience Research Australia
Outcome results
None listed