Digitally Delivered Treatments to Reduce Chronic Low Back Pain

Neuroscience Research Australia720 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

720

Conditions

Low Back Pain Chronic Pain (Back / Neck)General Practice (GP), Primary Care Settings Digital Health Hypnosis, Chronic Pain Management

Interventions

Pain education and clinical hypnosis delivered via a mobile appBEHAVIORAL

Pain education and clinical hypnosis will be delivered via a mobile app. The 8-week intervention includes daily sessions on pain education and clinical hypnosis for managing back pain (5 minutes of education, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes). The first six weeks will be semi-standardised, with participants following a set program with the option to repeat sessions. The last two weeks will be flexible, allowing participants to choose a specific program or self-paced continuation of the intervention. Adherence will be monitored by tracking the number of days participants complete sessions, as recorded by the mobile app.

Guideline-informed factsheetBEHAVIORAL

A single guideline-informed factsheet for back pain delivered via a webpage. Participants will be informed that the factsheet intends to provide reassurance for their back pain and encourage reflections on treatments and self-management options.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Pain intensity

Average pain intensity over the past 7 days measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable)

Time frame: Week 8 post-randomisation

Disability

Disability will be measured using the Roland-Morris Disability Questionnaire scale, ranging from 0 to 24, with higher scores representing higher levels of disability.

Time frame: Week 8 post-randomisation

Secondary Outcomes

Pain intensity

Average pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).

Time frame: Weeks 12, 26 and 52 post-randomisation

Disability

Disability will be measured using the Roland Morris Disability Questionnaire, 0 to 24, with higher scores representing higher levels of disability.

Time frame: Weeks 12, 26 and 52 post-randomisation

Worst pain intensity

Worst pain intensity over the past 7 days will be measured using the Numeric Rating Scale, 0 (no pain) to 10 (worst pain imaginable).