NOTUS Feasibility Study: Reducing Chronic Low Back Pain With Mobile App Intervention

NCT06605248 | Completed

• 1 other identifier: X23-0202 & 2023/ETH00540
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (16)

• Individuals meeting the preliminary eligibility criteria

  Proportion of individuals meeting the preliminary eligibility criteria in the pre-consultation tool BetterConsult and who agreed to receive a digital intervention as part of the study, compared to all eligible individuals reporting back pain as the primary health issue in the BetterConsult tool (data from BetterConsult).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• General practitioners who agreed to prescribe a digital intervention

  Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria

  Proportion of individuals who received the Participant Information Form and shared their name, phone number, and email to be contacted by the research group (data from the research group) compared to those who met the preliminary eligibility criteria and whose general practitioners agreed to prescribe a digital intervention as part of the trial (data from BetterConsult).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Individuals who completed the full eligibility criteria compared to those who shared their details

  Proportion of individuals who completed the full eligibility criteria for the study compared to those who shared their details after receiving the Participant Consent Form (data from the research group).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Number of individuals who provided consent to participate

  Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Number of individuals who provided consent for the research group to collect MBS and PBS data.

  Number of individuals who provided consent for the research group to collect Medicare Benefits Scheme and Pharmaceutical Benefits Scheme data (collected by the research group via REDCap).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Proportion of individuals who completed the baseline questionnaires

  Proportion of individuals who completed the socio-demographic baseline questions compared to all individuals who consented to participate in the feasibility study (data from the research group).

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• Recruitment rate per day, week or month.

  Number of individuals randomised in a given day, week or month (collected by the research group via REDCap)

  From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.

• The Acceptability of Intervention Measure

  The Acceptability of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher scores indicate greater acceptability.

  Baseline and 8 week follow-up

• The Appropriateness of Intervention Measure

  The Appropriateness of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher score indicates a higher level of appropriateness.

  Baseline and 8 week follow-up

• Completion rate of questionnaires

  The completion rate of questionnaires at baseline and the eight-week follow-up include: 0 to 10 numeric rating scale average pain and worst pain intensity, 0 to 24 Ronald Morris Disability Questionnaire and DASS-21 (depression, anxiety and stress sub-scales), higher scores indicate worse outcomes. Acceptability of Intervention Measure and Intervention Appropriateness Measure (1 to 5, higher scores indicate better outcomes) The completion rate of questionnaires at the 8-week follow-up include: -5 to 5 Global Perceived Effect Scale, 0 to 1 EuroQol 5 dimensions questionnaire, 0 to 12 Short-Form Pain Self-Efficacy Questionnaire, 0 to 100 Credibility/Expectancy Questionnaire (expectancy sub-scale) and 1 to 5 Mobile App Rating Satisfaction Sub-Scale, higher scores indicate better outcomes. 0 to 28 Short-Form Pain Catastrophising Scale, 9 to 45 Back Beliefs Questionnaire, 11 to 44 Short-Form Tampa Scale for Kinesiophobia, higher scores indicate worse outcomes.

  Baseline and 8 week follow-up

• Adherence to the digital intervention

  The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health).

  Throughout the intervention to the 8 week follow-up

• Mobile App Rating Satisfaction Sub-Scale

  We will assess satisfaction sub-scale using two questions from the Mobile App Rating Scale. Each item ranges from 1 to 5 (higher score indicates a greater level of satisfaction).

  8 week follow-up

• Participants experience through semi-structured interview

  Qualitative study on participants experience in the feasibility study (with at least 6 participants).

  8 week follow-up

• Adverse events

  Assessed by self-reported information

  8 week follow-up

• Participants experience with the intervention

  This study will qualitatively investigate the participants experience with three open-ended questions. These questions include: 1. What have you learned or experienced that has been the most helpful to you? 2. How do you see yourself applying the intervention to your daily life in the long term? 3. What else could we do to help you incorporate the intervention into your daily life?

  8-week follow-up

Study Arms (2)

App-based self-management tool plus usual care

EXPERIMENTAL

App-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care.

Behavioral: App-based self-management tool plus usual care

Patient information digital fact-sheet plus usual care

EXPERIMENTAL

The intervention consists of a fact-sheet delivered after usual care.

Behavioral: Patient information digital fact-sheet plus usual care

Interventions

App-based self-management tool plus usual care BEHAVIORAL

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.

App-based self-management tool plus usual care

Patient information digital fact-sheet plus usual care BEHAVIORAL

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.

Patient information digital fact-sheet plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Neuroscience Research Australia: lead

Study Sites (1)

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James H McAuley, PhD

  Neuroscience Research Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 20, 2024
• Study Start: October 8, 2024
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available after the publication of study reports. There is no end date for the availability of study data.
• Access Criteria: Protocol and ethics must be provided.

Locations

AU (1)