Skip to content

Feasibility of testing the effectiveness of a theory-informed implementation intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial

Feasibility of testing the effectiveness of a theory-informed implementation intervention consisting of general practitioner training to use a low back pain patient education and management booklet designed to reduce imaging for low back pain: a pilot cluster randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000991112
Enrollment
10
Registered
2019-07-11
Start date
2019-09-02
Completion date
2020-01-29
Last updated
2021-02-16

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

Conditions

None listed

Brief summary

Imaging is overused in the management of low back pain, resulting in high healthcare costs and poorer patient outcomes. Previous strategies to reduce imaging have been largely ineffective. In prior work our research team has developed an intervention to reduce non-indicated imaging for low back pain. Prior to future effectiveness testing of the intervention, it is important to assess the feasibility of using the intervention in clinical practice and conducting a large-scale randomised controlled trial (RCT). The overall aim of this study is to perform a pilot cluster RCT to determine the feasibility of a fully powered effectiveness study, and to assess the feasibility of implementing the developed intervention in clinical practice. This is critical to gain funding for future effectiveness testing using a large high-quality cluster RCT.

Interventions

Low back pain education and management booklet General practitioners in the intervention group will be provided with a 30 minute face-to-face individual training session with one of the research team. The researcher administering the training session will be a chiropractor with PhD qualification who was involved in the development of the intervention. The training session will include information on appropriate use of imaging for low back pain, an introduction to the low back pain booklet and w

Low back pain education and management booklet General practitioners in the intervention group will be provided with a 30 minute face-to-face individual training session with one of the research team. The researcher administering the training session will be a chiropractor with PhD qualification who was involved in the development of the intervention. The training session will include information on appropriate use of imaging for low back pain, an introduction to the low back pain booklet and why it was developed, and instruction on how the booklet is intended to be used in practice. Practitioners will also be provided with hardcopy and digital copies of the booklet, a digital version of the training presentation, an information sheet summarising the training information, and copies of recent guidelines regarding low back pain management and appropriate use of imaging. Practitioners will be given an opportunity to ask questions regarding the study or use of the booklet. Practitioners will be contacted fortnightly during the 4 month study period by phone and/or email as per practitioner preference to check if they have any questions related to delivering the intervention. The development of the booklet has been published in BMC Health Services Research, including access to a PDF copy of the booklet, available at: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-018-3526-7 The booklet has been designed to be used by practitioners during a low back pain consult to help educate patients about low back pain and why imaging is not usually necessary. Included in the booklet are: 1. A flow chart for practitioners to indicate to patients whether they need or don't need imaging. 2. Information about the nature of low back pain. 3. Information about imaging and why it is not usually helpful in the management of low back pain. 4. General advice for the management of low back pain. 5. A personalisable management plan for practitioners to provide specific management advice to the patient for their low back pain, including follow-up advice and warning symptoms to watch out for. 6. Further evidenced-based resources for patients to access for more information about low back pain. General practitioners will be instructed to use the low back pain booklet during the four month study period in clinical consults with patients presenting with low back pain, who do not require imaging, as they deem appropriate. Practitioners can use the booklet to screen the patient, demonstrate to the patient why they do not require imaging, provide the patient with information about low back pain and why imaging is not usually useful, and provide the patient with a customised management plan. Practitioners can either provide the patient with the hard copy version, or print out or email the patient the digital version. At the end of the study period practitioners will be asked to undertake a short 10-15 minute interview (either face to face or over the phone) with the same researcher who performed the training. Qualitative information on intervention adherence and fidelity will be collected by asking practitioners about their experiences in the study, how they used the booklet, and which patients they chose to use it with. To continue reminding practitioners to use the booklet and improve fidelity, practitioners will be contacted fortnightly during the 4 month study period by phone and/or email as per practitioner preference to check if they have any questions related to delivering the intervention.

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

General practice inclusion: - at least two general practitioners within the clinic - see patients presenting with low back pain - use practice management software to record patient consults, with the ability to search and extract data from the system (ie. Medical Director or Best Practice) General practitioner inclusion: - work at one of the included practices, for at least 10 hours per week - see patients with low back pain - provide consent to access Medicare Billing Schedule data

Exclusion criteria

None in addition to inclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026