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

Neuroscience Research Australia

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Behavioral: App-based self-management tool plus usual care; Behavioral: Patient information digital fact-sheet plus usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06605248

X23-0202 & 2023/ETH00540 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

App-based self-management tool plus usual care

Experimental group

Description:

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

Treatment:

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

Patient information digital fact-sheet plus usual care

Experimental group

Description:

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

Treatment:

Behavioral: Patient information digital fact-sheet plus usual care