Review opposes surgical intervention with spinal cord stimulation outside clinical trials

MedTech News: Spinal cord stimulation (SCS), a surgical intervention used to treat persistent low back pain, does not provide long-term relief and may cause harm, according to a new Cochrane Review.

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. Medtronic, Abbott, Boston Scientific and Nevro are key players in this market.

The researchers analysed the results of 13 clinical trials, looking at data from 699 participants, comparing spinal cord stimulation treatment with placebo or no treatment for low back pain.

The review concluded that spinal cord stimulation is no better than a placebo for treating low back pain, with probably little to no benefit for people with low back pain or improvement in their quality of life.

“Data in this review do not support the use of spinal cord stimulation to manage low back pain outside a clinical trial. Current evidence suggests spinal cord stimulation probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” the authors Traeger et al said.

There was little to no clinical data regarding the long-term effectiveness of spinal cord stimulation. The researchers also found that adverse side effects to the surgery were poorly documented overall, preventing them from concluding the level of risk involved. Harms from spinal cord stimulation could include nerve damage, infection, and the electrical leads moving, all of which may need repeated surgeries.

The review findings have been submitted to the Federal Department of Health and Aged Care prosthesis list review taskforce, the taskforce that is reviewing the eligibility of current prostheses subsidised by Medicare.

In Australia, the medical devices’ long-term safety and performance are also being re-assessed by the Therapeutic Goods Administration (TGA).

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead researcher Dr Adrian Traeger from Sydney Musculoskeletal Health, an initiative of the University of Sydney, Sydney Local Health District and Northern Sydney Local Health District.

“Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.

“Low back pain is one of the leading causes of disability worldwide. Our findings further emphasise the urgent need to review funding arrangements for chronic pain care to help patients in their search for relief. There are evidence-based physical and psychological therapies for back pain; ensuring access to these is essential.”

The review team found multiple gaps in clinical data. There were no studies that investigated the long-term (more than 12 months) impact of spinal cord stimulation on low back pain. The longest was a single six-month trial. The majority of clinical trials only looked at the immediate impact of the device, which is a time frame of less than a month.

The review team provided a list of recommendations, including that future spinal cord stimulation clinical trials be at least 12 months, clearly document the number of people who experience adverse events and make comparisons with other pain treatment options.

Professor Chris Maher, Co-Director of Sydney Musculoskeletal Health, said “Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators.”

A separate Cochrane review, in which the researchers were not involved, examined the effect of spinal cord stimulation versus placebo in people with chronic pain. Similar to this review, it concluded there was a lack of evidence to suggest long-term benefits in treating chronic pain.

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