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Recruiting NCT06984354

Digitally Delivered Treatments to Reduce Chronic Low Back Pain

No phase Interventional Low Back Pain Chronic Pain (Back / Neck) General Practice (GP), Primary Care Settings Digital Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain education and clinical hypnosis delivered via a mobile app, Guideline-informed factsheet.
Who it may be relevant to
Registry conditions: Low Back Pain, Chronic Pain (Back / Neck), General Practice (GP), Primary Care Settings, Digital Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

NOTUS Trial: A Randomised Controlled Trial of Two Digitally Delivered Treatment Options for Chronic Back Pain

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.

Interventions

  • Behavioral 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
  • 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.

Primary outcome measures

  • Pain intensity [Time frame: Week 8 post-randomisation]
  • Disability [Time frame: Week 8 post-randomisation]
Secondary outcome measures (8)
  • Pain intensity [Time frame: Weeks 12, 26 and 52 post-randomisation]
  • Disability [Time frame: Weeks 12, 26 and 52 post-randomisation]
  • Worst pain intensity [Time frame: Weeks 8, 12, 26 and 52 post-randomisation]
  • Adverse events [Time frame: Week 8 post-randomisation]
  • Health-related quality of life [Time frame: Weeks 8, 12, 26 and 52 post-randomisation]
  • Global impression of change [Time frame: Weeks 8, 12, 26 and 52 post-randomisation]
  • Anxiety symptoms [Time frame: Weeks 8, 12, 26 and 52 post-randomisation]
  • Depression symptoms [Time frame: Weeks 8, 12, 26 and 52 post-randomisation]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Neuroscience Research Australia — Randwick

Identifiers

NCT: NCT06984354 · iRECS4383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗