NCT07205991

Brief Summary

This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is: Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain? Participants will: A) Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
25mo left

Started Oct 2025

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025May 2028

First Submitted

Initial submission to the registry

September 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

September 25, 2025

Last Update Submit

January 12, 2026

Conditions

Low Back Pain

Keywords

Back PainDigital HealthHypnosisPain EducationChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Number of sessions completed

    Mean difference of the number of sessions completed over 8 weeks between groups.

    Week 8 post-randomisation

Secondary Outcomes (4)

  • Adherence rate (completer vs. non-completer)

    Week 8 post-randomisation

  • Missing follow-up rate

    Week 8 post-randomisation

  • Withdrawal rate

    Week 8 post-randomisation

  • Cost-effectiveness

    Week 8 post-randomisation

Study Arms (3)

App notifications

ACTIVE COMPARATOR

Participants will receive the standard app notifications. Reminders are automatically sent at 8pm each day. A user can change the time of their reminder or turn off reminders in the app. The purpose of the app notifications is to increase motivation to complete the app sessions. An example app notification is: Your path to pain management is just a session away. Have you listened today?

Behavioral: App notifications

Phone calls

EXPERIMENTAL

Participants will receive standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two phone calls or voice messages, one week apart. The purpose of these calls will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. We expect the calls to last no longer than five minutes. The phone call will include the following communication: Hi \[Name\], it's \[Researcher\] from Neuroscience Research Australia calling about the NOTUS back pain trial. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system.

Behavioral: Phone calls

Text messages

EXPERIMENTAL

Participants will receive the standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two SMS reminders, one week apart. The purpose of these SMS will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. The text messages will include the following: Hey \[Name\], this is \[Researcher\] from Neuroscience Research Australia. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system.

Behavioral: Text messages

Interventions

Phone callsBEHAVIORAL

Participants will receive standard app notifications and be contacted for adherence via two phone calls, a week apart, if they fail to engage with the intervention for more than three consecutive days. The purpose of these calls will be to assess whether participants are experiencing any difficulties using the app or completing the sessions.

Phone calls
Text messagesBEHAVIORAL

Participants will receive the standard app notifications and receive a maximum of 2 text messages (SMS) a week apart, if they fail to engage with the intervention for more than three consecutive days.

Text messages
App notificationsBEHAVIORAL

Participants will receive the standard app notifications .

App notifications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Randomised to experimental group at NOTUS Trial.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuroscience Research Australia

Sydney, New South Wales, 2031, Australia

RECRUITING

Related Links

MeSH Terms

Conditions

Low Back PainBack PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

James H McAuley, PhD

CONTACT

+61293991266j.mcauley@neura.edu.au

Rodrigo RN Rizzo, PhD

CONTACT

(02) 9399 1000r.rizzo@neura.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
General practitioners and statisticians will be blind to group allocation. Blinding will be maintained for the entire duration of the trial until all data have been collected, and data analysis and interpretation have been completed. The personnel involved in the daily operations of the trial (e.g., research assistants and investigators who will provide possible technical support to participants and trial managers) will be unblinded to group allocation and will not be involved in the analyses.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will randomly allocate participants from the intervention group of the NOTUS Trial into one of three parallel arms in a 1:1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2025

First Posted

October 3, 2025

Study Start

October 30, 2025

Primary Completion (Estimated)

May 26, 2027

Study Completion (Estimated)

May 26, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee. Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be made available after the publication of the study reports. There is no end date for the availability of study data.

Locations

AU(1)