Digitally Delivered Treatments to Reduce Chronic Low Back Pain (NOTUS)

Neuroscience Research Australia

Status: Enrolling

Conditions: Hypnosis, Chronic Pain Management; Digital Health; General Practice (GP), Primary Care Settings; Chronic Pain (Back / Neck); Patient Education; Low Back Pain

Treatments: Behavioral: Guideline-informed factsheet; Behavioral: Pain education and clinical hypnosis delivered via a mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT06984354

iRECS4383

Details and patient eligibility

About

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Enrollment: 720 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 2 patient groups

Pain education and clinical hypnosis delivered via a mobile app

Experimental group

Description:

Pain education and clinical hypnosis for self-managing back pain, delivered via a mobile app.

Treatment:

Behavioral: Pain education and clinical hypnosis delivered via a mobile app

Guideline-informed factsheet

Active Comparator group

Description:

A guideline-informed factsheet for back pain, delivered via a webpage.

Treatment:

Behavioral: Guideline-informed factsheet