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HealthDay touts nerve device as ‘more effective,’ but data is from unpublished study with no control group

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3 Star

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New Nerve Stimulation Technique Might Relieve Back Pain

Our Review Summary

lower back painThis story reports on an study of 67 people with chronic back pain, most of whom reported feeling at least a little better after they had a dorsal root ganglion (DRG) stimulator implanted in their spine. An abstract of the study was presented at the annual meeting of the American Society of Anesthesiologists.

The story did a good job of reporting on the cost and availability of this procedure. However, it didn’t acknowledge that the study’s findings are unreliable because there was no comparison with a control arm of patients who didn’t get the device. The story also played up an unsupported claim that this therapy could reduce opioid use and didn’t disclose that one source has significant conflicts of interest.

 

Why This Matters

Back pain is common and aggravating, and patients are often willing to try anything for relief. News stories should offer plenty of cautions about potential treatments that don’t have solid evidence of a benefit, particularly if they are risky and invasive procedures. Moreover, journalists should flag conflicted doctors who make money off of implanting devices and resist the temptation to report unsubstantiated claims that an intervention can reduce opioid use.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story did great on this criterion. It said the cost of spine stimulation devices “can range from $15,000 to $50,000 or more, according to a 2008 report funded by the Washington State Department of Labor and Industries.” It also mentioned the procedure “isn’t covered by all insurance companies, so out-of-pocket costs to patients can be very high.” One quibble we did have is that it isn’t clear whether the device to stimulate the dorsal root ganglion is different in cost than the other types of spinal cord stimulation.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story makes this claim high up:

The [DRG] therapy, which targets the root ganglion nerves, is more effective than other spine stimulation procedures because it places tiny leads precisely at the area where pain originates, unlike other devices that provide more generalized stimulation, the researchers said.

While there are theoretical reasons why DRG stimulation may be better than spinal cord stimulation, only studies directly comparing these treatments can determine this, and there is no mention of such studies in this piece.

Based on the study findings that are discussed, it may have helped some patients, but the story needed to make it clear that we can’t know from this one study if it’s better than alternatives. It’s also unfounded to speculate that it may reduce the use of opioid drugs.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story said the procedure “was not without complications. Five patients needed to have the wires implanted again, two patients had them removed because they were infected, and one had the device removed because of a complication.”

The story didn’t describe the complication, which was a foot drop. It could have also gone a step further by cautioning that the FDA often does not require new medical devices to prove that they are safe or effective in order to be used in people.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story includes some details of the study, such as that the device was implanted in 67 people with chronic back pain who were followed for three to 18 months, and just 17 had the device for more than a year. It also noted that the the findings were presented at the American Society of Anesthesiologists meeting, and that research presented at meetings “is considered preliminary until published in a peer-reviewed journal.”

However, as we discussed in the benefits criterion, the story should have cautioned that this study didn’t have a comparison group of patients that didn’t get the treatment. As a result, it’s impossible to know whether the reported improvements are the result of a placebo effect or if these patients would have seen their intense pain ease up as a natural course of their condition, regardless of any treatment.

The story also reported one researcher’s assertion that the therapy “has the potential to allow patients to stop taking opioids to control their pain” yet offers no data to support that.

Does the story commit disease-mongering?

Not Satisfactory

The story didn’t exaggerate the incidence of chronic back pain, though some numbers would have been helpful.

Low back pain is a common problem – almost everyone will have it at some point. However, only a small number, 7-12%, go on to develop chronic, disabling pain. That said, this still represents millions of adults in the US, and is well known to be a contributor to the opioid epidemic of physician prescribing for chronic musculoskeletal pain.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The authors of this study reported no conflicts of interest in the abstract. However, the story didn’t mention that a doctor who’s quoted, Kiran Patel, MD, received nearly $12,000 in 2017 from Abbott Laboratories, which makes a DRG device. Kiran is also listed as a “DRG specialist” on Abbott’s web site.

Further, the story didn’t say who funded this study.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story said DRG stimulation may help “patients who have not gotten relief from other treatments.” We would have liked a sentence or two about other ways to deal with back pain.

There are many treatments for chronic low back pain, but none are known to offer a cure with a reasonable degree of certainty. Treatments often focus on medicines to control pain, but there is increasing interest in non-pharmacological treatments to control pain and improve function, such as exercise, physical therapy, yoga, Tai chi, acupuncture, spinal manipulation, mind-body techniques, cognitive behavioral therapy, along with others. Invasive treatments may include injectable medicines, but they have limited duration of benefit for a chronic problem.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story reported that the device was approved by the FDA in 2016 and its use is confined to “more advanced medical centers where doctors have been trained in how to implant and regulate the device.”

Also, it said the procedure “isn’t covered by all insurance companies, so out-of-pocket costs to patients can be very high,” though it is covered by Medicare.

Does the story establish the true novelty of the approach?

Satisfactory

The story did not establish novelty–what other studies have been done on this type of therapy for chronic back pain? Is this the first?

The new device mentioned here, that stimulates the dorsal root ganglion, is argued to be more specific than the older stimulation devices. A number of issues not raised in this piece make the potential value of DRG stimulation less clear. First, is that being more precise, doctors need to identify the pain generator site (the source of the pain). For many patients this can be hard to find. Moreover, there may be more than one pain source, arguing that multiple DRG’s may need to be targeted. This may explain why pain is not eliminated, but only decreased, for this study population.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story doesn’t appear to rely on a news release.

Total Score: 6 of 10 Satisfactory

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