spinal cord stimulation and efficacy

Despite their increasing use for chronic pain, spinal cord stimulators have not proven to be more effective than conventional medical management. In fact, a new analysis finds, they are costly and associated with adverse events.

https://jamanetwork.com/journals/jamaneurology/article-abstract/2799084

A paper published in JAMA Neurology caught our attention. This large study comparing spinal cord stimulation with conventional medical management not only suggests a lack of clinical benefit for spinal cord stimulations but also reports that the latter is associated with higher costs and potential for harm for some patients.

The use of spinal cord stimulators is not associated with reductions in opioid use or nonpharmacologic pain interventions, including epidural and facet corticosteroid injections, radiofrequency ablation, and spine surgery, a new study reveals. Nor is it more effective than conventional medical management of chronic pain.

Spinal cord stimulators, which have been used increasingly in recent years, are neuromodulation devices implanted in the epidural space to manage chronic pain that fails to respond to conventional treatment. About 50,000 are implanted annually in the United States at a cost of roughly $3.5 billion. Some experts have recommended more widespread use of these devices to lower the risks of medications, including opioids and gabapentinoids.

Despite their growing use, the study’s authors state the evidence supporting spinal cord stimulators over usual care has limitations. They contend that the US Food and Drug Administration (FDA) authorized most stimulators without clinical data. They pointed out that the manufacturers provided funding for an estimated 85 percent of large studies (involving more than 100 patients) using these stimulators and therefore there is propensity of bias in any publication.

Typically, independent evaluations have been small, single-centre, and nonrandomized.

While some studies found benefit in pain relief at six months from spinal cord stimulators compared with conventional medical management, benefits are often depleted after 12 to 24 months. In addition, the authors pointed out that the comparator group in many trials of the devices did not sufficiently mask a placebo effect. When a placebo control is used, treatment effects are more modest.

SCS is also associated with potentially serious side effects. In September 2020, an FDA letter addressed to health care professionals noted that more than 107,000 medical device adverse-event reports related to spinal cord stimulators had been filed between July 2016 and July 2020. The incidents included patient injury, device malfunction, and 497 deaths. Also, among 4,000 types of medical devices tracked by the FDA, spinal cord simulators had the third-highest number of adverse events.

The researchers state. “Our study is as rigorous of a real-world evaluation of spinal cord stimulators as is possible,”

Our findings provide important information to help inform clinicians and policymakers about the need for greater use of evidence-based therapies for pain relief,” There may be opportunities to redeploy the high—and increasing—use and spending associated with spinal cord stimulators toward more evidence-based interventions for chronic pain relief,”

At ACT for PAIN, we re-state that whether patients in chronic pain are managed with physiotherapy, tablets, pain injections or advanced treatments such as SCS, or a combination of all these, it is likely that they will continue to experience daily intrusive levels of pain. This is likely to lead to mental health issues of anxiety, low mood and depression which can worsen the perception of pain. Our online program represents an affordable way of managing the psychological component of living with chronic pain.

 

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