Spinal cord stimulators back in the spotlight as Australian study contradicts existing evidence

The debate over spinal cord stimulators (SCS) has resurfaced with new research challenging the safety, efficacy and financial burden of this commonly used medical device for lower back pain. The study’s findings, which stand in stark contrast to existing evidence, suggest that one in four patients who receive a spinal cord stimulator later require additional surgery to fix complications.

Neuromodulation provides pain relief for patients suffering from failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS) and intractable cancer pain. Although neuromodulation is not a treatment used in isolation to treat patients, it facilitates an effective treatment pathway particularly where conventional treatment methods fail to provide effective pain relief.

In this retrospective observational study, researchers analysed data from five Australian private health insurers and discovered a significant rate of surgical reinterventions – most within the first three years.

“The median time to reintervention was only 17 months, which means patients and the healthcare system are taking on a lot of cost and risk for a device that has evidence that it is ineffective,” said Dr Caitlin Jones, first author and postdoctoral research associate at the School of Public Health and Institute of Musculoskeletal Health, University of Sydney.

“For people who had the device inserted as a trial only, the cost to the insurer was about $14,000. People who advanced to a permanent implant cost the insurer about $55,000, but there are some outliers we found where surgical costs associated with these devices exceeded half a million dollars per patient,” she added.

“Given the convincing evidence that spinal cord stimulators do not reduce pain – and the concerning frequency of patient harm – we have to ask whether they should be used at all to treat lower back pain. These findings add serious weight to the argument that their use needs urgent reconsideration.”

Yet, this perspective is far from universally accepted.

One of the largest studies to date, from the RELIEF registry, paints a different picture. Tracking real-world outcomes from Boston Scientific SCS devices across 79 international sites over three years, the registry found that the overall yearly incidence of device explant was 3.5%. That figure dropped to 1.1% when explant was specifically due to inadequate pain relief. Over the three-year period, the total explant rate was 7.6%, falling to 2.5% for explants related to poor efficacy. The most common noted serious adverse event was implant site infection (<1%).

Backing this evidence, a report commissioned by the Neuromodulation Society of Australia and New Zealand (NSANZ), Painaustralia and the Faculty of Pain Medicine, Australia and New Zealand College of Anaesthetists, found that: “There is demonstrable evidence that SCS devices can halve the amount of pain a patient is in for more than 50% of the relevant population. With continual advances in technology in this area it is possible that upwards of 90% of patients can achieve this pain reduction.”

The report also argued that SCS is “cost effective from the perspective of the healthcare system” and that from a productivity perspective “SCS devices are dominant for both FBSS and CRPS patients. This is driven by the significant proportion of people who are able to return to work.”

Spinal cord stimulators are predominantly used in Australia’s private healthcare system, with nearly 90% of insertions performed in private hospitals. Their use has been growing, with 5,072 devices implanted in 2023–24 alone. This trend mirrors the rise in chronic back pain, affecting more than 4 million Australians in 2022, contributing to over 1,000 deaths, and costing an estimated $3.4 billion annually.

“Our new study highlights the cost associated with these devices, on top of their track record of poor performance and risk of issues like infection, tearing the lining around the spinal cord, or even unexplained increases in pain,” said Dr Jones.

“This study only examined data on the frequency and cost of surgical reinterventions related to these devices, so we can’t say why healthcare professionals continue to prescribe and implant stimulators despite the known issues. But this is an area of strong interest for future research.”

With polarising data and entrenched positions, the role of spinal cord stimulators in chronic pain management remains highly contested. Ultimately, the clinical judgment of the treating surgeon – grounded in the latest evidence and individual patient needs – remains essential in guiding care.

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.