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Information leaflets regarding diagnostic imaging for low back pain

Effect of three types of information leaflets on intention to undergo diagnostic imaging for non-specific low back pain: a randomised controlled trial in patients and the general public

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000392167
Enrollment
418
Registered
2019-03-12
Start date
2019-06-04
Completion date
2019-07-29
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to evaluate the effectiveness of different types of information leaflets on intention to undergo imaging for non-serious low back pain in patients with low back pain and the general public.

Interventions

This trial includes community participants and patient participants. Community participants will complete a survey (hosted by Qualtrics) on their computer. They will be asked to imagine that they have developed sudden, severe low back pain and have gone to their local emergency department. The scenario will state that before they have a consultation with the emergency department doctor, they pick-up a leaflet in the waiting room. At this point, the randomiser function in Qualitrics survey will

This trial includes community participants and patient participants. Community participants will complete a survey (hosted by Qualtrics) on their computer. They will be asked to imagine that they have developed sudden, severe low back pain and have gone to their local emergency department. The scenario will state that before they have a consultation with the emergency department doctor, they pick-up a leaflet in the waiting room. At this point, the randomiser function in Qualitrics survey will randomly allocate each community participant to view one of the three leaflets on their computer screen. The leaflets contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires. Patient participants will also be given one of three leaflets to read but will base their answers on their own experience rather than receive the hypothetical scenario. After consenting to participate, a research assistant will give patient participants, who are waiting for their appointment at a back pain clinic, an iPad on which to read the leaflet. At this point, the randomiser function in Qualitrics survey will randomly allocate each patient participant to view one of the three leaflets on the iPad. The leaflets (identical to those provided to community participants) contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires. Types of intervention leaflets: 1. Fact Box leaflet This leaflet contains "Fact Box" which contains balanced information on the benefits and harms of imaging for low back pain, presented side by side. 2. Nudge Leaflet This leaflet contains information that is biased towards highlighting the harms of imaging for low back pain, more than any benefits.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Community participants: Community sample of people with or without a history of low back pain. Patient participants: Patients with low back pain before seeing clinicians at a back pain clinic attached to a teaching hospital in Sydney, Australia.

Exclusion criteria

Participants who cannot speak English Patients who have undergone imaging for the recent episode of low back pain

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026