A quarter of patients who receive spinal cord stimulators require invasive corrective surgery. Image credit: Anna Shvets / Pexels CC4.0
A quarter of patients who receive spinal cord stimulators require invasive corrective surgery. Image credit: Anna Shvets / Pexels CC4.0

Spinal cord stimulators: ineffective treatment found to be costly and risky

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Peer-reviewed: This work was reviewed and scrutinised by relevant independent experts.

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New research from the University of Sydney reveals surgically implanted spinal cord stimulators – a common treatment for lower back pain which aims to disrupt pain signals travelling to the brain – are costly and putting patients at risk of needing ongoing surgical interventions to fix complications, with a quarter receiving the treatment going on to require corrective surgery.

Journal/conference: Medical Journal of Australia

Research: Paper

Organisation/s: The University of Sydney, Monash University, The University of New South Wales

Funder: This research received no external funding

Media release

From: The University of Sydney

New research from the University of Sydney reveals surgically implanted spinal cord stimulators – a common treatment for lower back pain which aims to disrupt pain signals travelling to the brain – are costly and putting patients at risk of needing ongoing surgical interventions to fix complications, with a quarter receiving the treatment going on to require corrective surgery.

Lower back pain is the biggest cause of disability globally with more than 600 million people affected.

Published in the Medical Journal of Australia, the study involved researchers analysing data supplied by five Australian private health insurers and found that one quarter of people who have a spinal cord stimulator implant will require invasive surgical reintervention to correct issues with the stimulator hardware, mostly within the first three years.

First author Dr Caitlin Jones, a postdoctoral research associate in the School of Public Health and Institute of Musculoskeletal Health said: “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.”

“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.”

“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,” said Dr Jones.

WHY ARE SPINAL CORD STIMULATORS USED?

Spinal cord stimulation is thought to work by implanting a device that sends electrical pulses to the spinal cord to interrupt nerve signals before they get to the brain. The devices are self-contained and should operate for around five years – the lifespan of their battery – before needing to be recharged.

Their use in Australia has been growing over the last decade, with 5072 stimulators implanted in 2023-24 alone coinciding with an increase in the number of people reporting back pain. Data from the Australian Institute of Health and Welfare shows 4 million Australians were living with back problems in 2022, contributing to over 1000 deaths and costing an estimated $3.4 billion to treat and manage these chronic issues.

However, ongoing research from the University of Sydney has uncovered several issues with spinal cord stimulators: a 2023 Cochrane Review found that they don’t help with back pain any better than a placebo effect; and a 2024 episode of ABC’s Four Corners covered the team’s analysis of adverse events linked to spinal cord stimulators, which found 79 percent were considered to be “severe”, with 13 percent considered “life threatening”.

“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.”

Dr Jones said the study is likely to underestimate the number and cost of surgical reinterventions as some common problems, such as when the stimulator’s electric leads needed to be repositioned, but new hardware was not required, were not captured in the dataset provided by health insurers.

“The issue could be even greater than our results suggest. The data wasn’t able to follow patients across insurers, which could have contributed to an underestimation of the reinterventions and cost per person,” she added. “People who found the devices to be ineffective but chose to leave them in place but turned off, would not have been detected in this dataset.”

Other ways to manage back pain

Dr Jones said that, despite discouraging results around spinal cord stimulators, there are still things that can help reduce or manage chronic back pain.

“In 2023 the World Health Organization identified a range of effective therapies for managing chronic back pain. Effective options include education, exercise, cognitive behavioural therapy and medicines such as non-steroidal anti-inflammatory medicines. Recent Australian research has shown that sensorimotor retraining and cognitive functional therapy are also effective. Your healthcare providers should be able to give you advice on what is best for your personal situation.

“Thankfully, Australia is at the forefront of back pain research, which is leading to safer, more effective therapies.”

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