Back pain study wins Clinical Trial of the Year

The Sydney Health Partners Emergency Department (SHaPED) trial slashed opioid prescriptions for low back pain by introducing an evidence-based model of care to emergency department clinicians. 

An estimated 80 per cent of Australians will experience low back pain during their lifetime. The condition is among the top 10 reasons given by patients visiting emergency departments across the country.  

“Low back pain can be quite challenging in the emergency department,” says Dr Danielle Coombs, a physiotherapist and researcher at the Institute for Musculoskeletal Health, a research partnership between Sydney Local Health District and the University of Sydney. “It takes a lot of time to manage that pain, and clinicians in the emergency department are often very busy.” 

For most cases of low back pain, guidelines and models of care do not recommend opioid painkillers, imaging or hospital admissions. Despite this, two-thirds of patients who visit the emergency department receive opioid medications and one-third undergo costly imaging procedures. One-third are admitted to hospital, even though few patients have serious spinal issues that require urgent medical attention. 

In 2018, Dr Coombs and Dr Gustavo Machado co-led the Sydney Health Partners Emergency Department (SHaPED) trial to help improve the management and treatment of low back pain in busy hospitals. The randomised trial evaluated a model of care developed by NSW Health’s Agency for Clinical Innovation (ACI), which recommends patients receive other self-management options, such as education, exercise and simple medicines, as a first step, instead of strong analgesics like opioids.  

The SHaPED trial was run in four NSW emergency departments, three of them in the Sydney Local Health District. It included over 4,500 patients and involved training almost 300 clinicians in assessing, managing and referring patients with low back pain based on the ACI’s model of care.  

Clinicians were given access to educational seminars and materials, non-opioid pain management strategies, and a dashboard showing real-time audit and feedback data on admission rates, opioid use and imaging. The SHaPED team received $90,000 of seed funding in 2016 from Sydney Health Partners, $315,000 from the NHMRC in 2017, and $20,000 from NSW Health’s ACI in 2018. 

The SHaPED trial slashed opioid prescriptions by 12 per cent across the four hospitals, with Sydney’s Canterbury Hospital recording the biggest drop of 24 per cent over four months. These results were sustained three years after the intervention was introduced.  

Additionally, clinicians’ knowledge and beliefs about low back pain had significantly improved. “Although emergency departments are very busy, we managed to change practice by implementing the ACI model of care,” says Dr Machado. 

Although fewer opioids were prescribed, the study also found patients didn’t experience worse pain and were just as satisfied with their care. “Patients received good pain relief using other evidence-based medicines and approaches,” says Dr Machado. 

Other factors for success in this trial included some of the researchers also being practicing clinicians (rheumatologists, physiotherapists and emergency department physicians). They brought local knowledge and trust, development of an electronic dashboard, enabling near real time audit and feedback on key outcomes and the novel introduction of single use heat wraps. The heat wraps are a non-pharmacological strategy giving an alternative option for both busy emergency department clinicians as well as for patients.   

In October 2022, the SHaPED team was awarded 2021 Clinical Trial of the Year by the Australia and New Zealand Musculoskeletal Clinical Trials Network. Other hospitals have adopted the SHaPED intervention, and it’s being trialled in the Royal Brisbane and Women’s Hospital emergency department. The team also received a $2.8 million grant from the Medical Research Future Fund last year to trial a physiotherapy-led model of care to improve patient flow in emergency departments across Australia. “Partnerships with patients, clinicians and government agencies were crucial to the success of this trial,” says Dr Machado.  

Roughly one-third of Australia’s clinical trials are run in NSW thanks to its efficient approvals process and superior infrastructure. While getting a clinical trial approved by ethics committees and governance officers can be a complex process, new policies and tools developed by NSW Health – such as the Research Ethics and Governance Information System (REGIS) – are smoothing the path. “It’s really changed in the last few years,” says Dr Machado. “We’ve really benefitted from that.”