Digitally Delivered Treatments to Reduce Chronic Low Back Pain

NCT ID: NCT06984354

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2028-05-26

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The statistician will be blinded to group allocation.

Study Groups

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Pain education and clinical hypnosis delivered via a mobile app

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

Group Type EXPERIMENTAL

Pain education and clinical hypnosis delivered via a mobile app

Intervention Type BEHAVIORAL

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 factsheet

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

Group Type ACTIVE_COMPARATOR

Guideline-informed factsheet

Intervention Type BEHAVIORAL

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.

Interventions

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Pain education and clinical hypnosis delivered via a mobile app

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.

Intervention Type BEHAVIORAL

Guideline-informed factsheet

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuroscience Research Australia

OTHER

Sponsor Role lead

Responsible Party

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James McAuley

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James H McAuley, PhD

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Research Australia

Locations

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Neuroscience Research Australia

Randwick, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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James H McAuley, PhD

Role: CONTACT

+61293991266

Rodrigo RN Rizzo, PhD

Role: CONTACT

(02) 9399 1000

Facility Contacts

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James H McAuley, PhD

Role: primary

+61293991266

Other Identifiers

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iRECS4383

Identifier Type: -

Identifier Source: org_study_id

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