Low Back Pain
Conditions
Keywords
Back Pain, Digital Health, Hypnosis, Pain Education, Chronic Pain
Brief summary
This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is: Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain? Participants will: A) Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.
Interventions
BEHAVIORALPhone calls
Participants will receive standard app notifications and be contacted for adherence via two phone calls, a week apart, if they fail to engage with the intervention for more than three consecutive days. The purpose of these calls will be to assess whether participants are experiencing any difficulties using the app or completing the sessions.
BEHAVIORALText messages
Participants will receive the standard app notifications and receive a maximum of 2 text messages (SMS) a week apart, if they fail to engage with the intervention for more than three consecutive days.
BEHAVIORALApp notifications
Participants will receive the standard app notifications .
Sponsors
Neuroscience Research Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
General practitioners and statisticians will be blind to group allocation. Blinding will be maintained for the entire duration of the trial until all data have been collected, and data analysis and interpretation have been completed. The personnel involved in the daily operations of the trial (e.g., research assistants and investigators who will provide possible technical support to participants and trial managers) will be unblinded to group allocation and will not be involved in the analyses.
Intervention model description
The study will randomly allocate participants from the intervention group of the NOTUS Trial into one of three parallel arms in a 1:1:1 ratio.
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. * Randomised to experimental group at NOTUS Trial.
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 |
|---|---|---|
| Number of sessions completed | Week 8 post-randomisation | Mean difference of the number of sessions completed over 8 weeks between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence rate (completer vs. non-completer) | Week 8 post-randomisation | Participants will be classified as completers if they have attended at least 24 sessions (new or repeated) during the 8-week treatment period of the host trial. This threshold represents an average of three clinical sessions per week over 8 weeks. |
| Missing follow-up rate | Week 8 post-randomisation | Participants will be classified as follow-up completer when they completed all primary, secondary and intermediate measures or as follow-up missing when they did not complete all primary, secondary and intermediate measures at the 8-week follow-up. |
| Withdrawal rate | Week 8 post-randomisation | Participants will be classified as withdrawal if they formally withdrew consent, or as non-withdrawal if they remained enrolled in the trial at the 8-week follow-up. |
| Cost-effectiveness | Week 8 post-randomisation | The mean difference in costs and adherence between groups will be used to calculate the incremental cost-effectiveness ratio (ICER), representing the average additional cost (expressed in Australian dollars - AUD) required to achieve one additional completed session. This outcome reflects the economic efficiency of each engagement strategy (SMS or phone call) compared to others. |
Countries
Australia
Contacts
Primary ContactJames H McAuley, PhD
Backup ContactRodrigo RN Rizzo, PhD
Outcome results
None listed