This story delivers some important information about how spinal stimulation devices have been investigated for use in chronic pain. But it does not make clear that the study upon which the story is based concerned patients for whom an initial surgery had failed. The story suggests that the procedure might be an alternative to initial surgery. The story also mentions complex regional pain syndrome (CRPS) as an indication for use of the device. But the study did not address this condition. Radicular pain – so-called "neuropathic pain" in the source study is not CRPS. Some of this framing conveys a message that is too bold while the jury is not yet in.
The story does accurately characterize the evidence about the device’s partial effectiveness and potential disadvantages. It includes interviews with four sources, and mentions conflicts of interest. Though the story mentions problems some people have with spinal stimulators, it overlooks some important ones, including infection and device migration. (See “Harms of Treatment’ above.) Importantly, it also neglects to point out the consensus view among pain experts that this is a treatment of last resort—to be used only after everything else has failed, including surgery.
The article notes the cost of the device alone ($20,000), the cost inclusive of hospital and other charges ($40,000), and the cost in comparison to other operations ("cheaper"). But let’s not forget that the alternatives include non-invasive treatment.
The story accurately characterizes the results of a 2007 multinational randomized trial showing that the device helped reduce pain by about half in about half of people who received the treatment, compared to only 9% of people receiving conventional medical treatments. The study is the largest of its kind and a fair representation of the literature. A 2004 review, for example, found that spinal cord stimulators provide mild to moderate pain relief in selected individuals for anywhere from 6 months to several years. (Pain 2004;108:137-47) Still, the story could have probed the absolute reduction in pain. For instance, halving moderate pain may be less beneficial than halving severe pain.
The story notes some annoyances and potential problems with the device (e.g. the “buzzing” vibration and the need for reoperations to replace dead batteries), but neglects to mention others. For example, the authors of the 2007 trial noted that electrode migration occurred in some 10% of patients and infections in 8%. A 2004 review by a leading group of pain experts noted that complications occur in about one-third of patients. Additional problems included pain near the site where the device is implanted, tears of the membrane that surrounds the spinal cord (the dura), and malfunctioning equipment. (Pain 2004;108:137-47)
The story discusses a 2007 multinational randomized trial, though it doesn’t offer much detail. The news story fails to mention some limitations of the trial (e.g. lack of blinding and lack of independent assessment by a third party). Even the editorial accompanying the published study pointed out that the trial didn’t have a "sham" arm" so there is no assurance that the study measured any possible placebo effect
The article does not make clear that the study upon which the story is based concerned patients for whom an initial surgery had failed. The story suggests that the procedure might be an alternative to initial surgery. The story also mentions complex regional pain syndrome (CRPS) as an indication for use of the device. But the study did not address this condition. Radicular pain – so-called "neuropathic pain" in the source study is not CRPS. Finally, the second paragraph suggests that this is an alternative for chronic pain. This is too bold a message while the jury is not yet in.
The story provides a good mix of sources, including one patient and three pain experts (one of whom relates the story of a dissatisfied patient). It also reports a potential conflict of interest among the authors of the study it cites, as well as with one of the expert sources.
The news story mentions several alternatives to spinal stimulators—bed rest, drugs, nerve blocks, and physical therapy. However, it neglects to point out the consensus view among pain experts that this is a treatment of last resort—to be used only after everything else has failed, including surgery.
The story explains that spinal stimulation devices “are not widely used,” though it does not mention that they are approved by the FDA for the treatment of chronic pain.
The news story doesn’t explain whether this is a new treatment, old treatment, or a new twist on an old idea.
The story turned to several different sources, making it unlikely that it relied solely or largely on a press release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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