Clinical trial NCT06605248: NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention
Official title: NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management With Mobile App-based Pain Education and Clinical Hypnosis in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Neuroscience Research Australia
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This feasibility study will investigate the feasibility of screening, recruiting, and delivering a mobile app intervention that involves pain education and clinical hypnosis to people seeking treatments for chronic low back pain (chronic LBP) in general practices in Australia.

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.


Eligibility criteria: Inclusion Criteria:

* Experiencing chronic LBP, defined as pain in the area between the 12th rib and buttock crease accompanied or not by leg pain for a minimum duration of 12 weeks.
* 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:

* Known or suspected back-specific (e.g., radiculopathy, fracture) or non-back-specific (e.g., tumour, infection) serious spinal 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 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).

Primary outcomes:
measure: Individuals meeting the preliminary eligibility criteria
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: General practitioners who agreed to prescribe a digital intervention
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Individuals who completed the full eligibility criteria compared to those who shared their details
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Number of individuals who provided consent to participate
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Number of individuals who provided consent for the research group to collect MBS and PBS data.
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Proportion of individuals who completed the baseline questionnaires
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: Recruitment rate per day, week or month.
timeFrame: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
measure: The Acceptability of Intervention Measure
timeFrame: Baseline and 8 week follow-up
measure: The Appropriateness of Intervention Measure
timeFrame: Baseline and 8 week follow-up
measure: Completion rate of questionnaires
timeFrame: Baseline and 8 week follow-up
measure: Adherence to the digital intervention
timeFrame: Throughout the intervention to the 8 week follow-up
measure: Mobile App Rating Satisfaction Sub-Scale
timeFrame: 8 week follow-up
measure: Participants experience through semi-structured interview
timeFrame: 8 week follow-up
measure: Adverse events
timeFrame: 8 week follow-up
measure: Participants experience with the intervention
timeFrame: 8-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Neuroscience Research Australia
state: New South Wales
Study officials:
affiliation: Neuroscience Research Australia
name: James H McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References: