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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain education and clinical hypnosis delivered via a mobile app | Experimental | Pain education and clinical hypnosis for self-managing back pain, delivered via a mobile app. |
|
| Guideline-informed factsheet | Active Comparator | A guideline-informed factsheet for back pain, delivered via a webpage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain education and clinical hypnosis delivered via a mobile app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable) | Week 8 post-randomisation |
| 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. | Week 8 post-randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weeks 12, 26 and 52 post-randomisation |
| Disability |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomisation to week 52 post-randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James H McAuley, PhD | Contact | +61293991266 | j.mcauley@neura.edu.au | |
| Rodrigo RN Rizzo, PhD | Contact | (02) 9399 1000 | r.rizzo@neura.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| James H McAuley, PhD | Neuroscience Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroscience Research Australia | Recruiting | Randwick | New South Wales | 2031 | Australia |
De-identified individual participant data will be made available to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee.
Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).
Data will be made available after the publication of the study reports. There is no end date for the availability of study data.
Protocol and ethics must be provided.
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The statistician will be blinded to group allocation.
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|
| Guideline-informed factsheet | Behavioral | 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. |
|
Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.
| Weeks 12, 26 and 52 post-randomisation |
| 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). | Weeks 8, 12, 26 and 52 post-randomisation |
| Adverse events | Adverse events will be assessed using self-reported information during the trial. | Week 8 post-randomisation |
| Health-related quality of life | 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. | Weeks 8, 12, 26 and 52 post-randomisation |
| Global impression of change | 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). | Weeks 8, 12, 26 and 52 post-randomisation |
| Anxiety symptoms | 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. | Weeks 8, 12, 26 and 52 post-randomisation |
| Depression symptoms | 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. | Weeks 8, 12, 26 and 52 post-randomisation |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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