NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention
NCT ID: NCT06605248
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-10-08
2025-03-13
Brief Summary
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This study aims to assess the recruitment strategy, the willingness of participants to be included in the proposed treatments, whether the intervention can be delivered as intended within the health care system and clinical setting, the adherence of participants to the proposed treatment, response rates to questionnaires, loss to the short-term follow-up, and the appropriateness and acceptability of the interventions. This feasibility study will inform possible modifications in the recruitment and treatments for the main clinical trial.
A total of 60 participants will be randomised into two treatment groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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App-based self-management tool plus usual care
App-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care.
App-based self-management tool plus usual care
The app-based self-management tool will be delivered after patients receive usual care from their general practitioners. The 8-week mobile app intervention will involve daily sessions on pain education and clinical hypnosis for back pain management (5 minutes, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes.
Patient information digital fact-sheet plus usual care
The intervention consists of a fact-sheet delivered after usual care.
Patient information digital fact-sheet plus usual care
The face-sheet will be delivered after patients receive usual care from their general practitioners.This digital intervention will contain educational material for chronic back pain that includes details about diagnosis, prognosis and treatment options.
Interventions
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App-based self-management tool plus usual care
The app-based self-management tool will be delivered after patients receive usual care from their general practitioners. The 8-week mobile app intervention will involve daily sessions on pain education and clinical hypnosis for back pain management (5 minutes, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes.
Patient information digital fact-sheet plus usual care
The face-sheet will be delivered after patients receive usual care from their general practitioners.This digital intervention will contain educational material for chronic back pain that includes details about diagnosis, prognosis and treatment options.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
ALL
No
Sponsors
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Neuroscience Research Australia
OTHER
Responsible Party
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James McAuley
Principal Investigator
Principal Investigators
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James H McAuley, PhD
Role: PRINCIPAL_INVESTIGATOR
Neuroscience Research Australia
Locations
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Neuroscience Research Australia
Randwick, New South Wales, Australia
Countries
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Other Identifiers
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X23-0202 & 2023/ETH00540
Identifier Type: -
Identifier Source: org_study_id
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