To read this release, one would come away with the impression that nearly everybody suffers from low back pain and that nearly everybody could benefit from “image-guided pulsed radiofrequency treatment.” This impression is built on a faulty structure. There is not enough data provided in a clear enough way. The true context around low back pain prevalence is not presented in a realistic way. Nor are the costs and caveats around the quality of evidence included.
It would have been helpful if the release had noted that the study, presented at a medical conference, has not been peer reviewed or published.
A story by NBCNews.com, which we also reviewed, provides readers with a lot of the information that’s missing from the release, mainly through interviews with outside experts.
There have been numerous reports on new low back pain treatments that sound amazing, but often turn out to be too good to be true. This release does a good job of hyping a new treatment for one type of low back pain. The headline and start of the release refer to low back pain in general and how common it is. The study reported here focuses on one type of back pain that is due to a herniated disc that pinches nerves coming out of the back that go to the legs. These patients have leg pain in addition to back pain.
A herniated disc is probably the cause of low back pain for fewer than 10 percent of patients. Moreover, most patients with pain due to a herniated disc will improve with conservative treatment. So the patients in this study actually only represent a few percent of patients with low back pain.
There is no mention of costs in the release.
The release addresses benefits with this statement: “Of the 80 patients treated, 81 percent were pain free one year after a single 10-minute treatment session. Six patients required a second pulsed radio-frequency session. Ninety percent of the patients were able to avoid surgical treatment.” This would imply that 65 of 80 patients had pain relief at one year.
The release does mention side effects, saying, “Dr. Napoli said no patients experienced side effects after receiving the minimally invasive outpatient treatment.”
But just because there were no side effects in this small study, does that mean there is no risk of such side effects for anyone? That seems like downplaying the risks. The release would have been more thorough had it mentioned that any invasive treatment such as this one carries a risk of infection.
The release does not adequately describe the quality of the evidence. It does not explain that these results are not peer reviewed nor published. And it does not provide any sort of caveats around potential shortcomings of the approach.
It’s a weakness of the study that there was no comparative group. As an expert interviewed by NBC News for a story on this study explained: “We don’t know what would have happened if compared to nothing or sham,” said Dr. Seth Waldman, director of pain management at the Hospital for Special Surgery. “More research needs to be done in a randomized control trial.”
Finally, the release might also leave readers with the impression that the pain relief seen is entirely due to the intervention when we know that a substantial portion of patients with back pain will get better on their own. It’s misleading not to point this out.
The release overstates the severity of the problem of low back pain, and it doesn’t need to. Pain is a very real problem in the United States and around the world. But stating that “Low back pain is an extremely common problem that affects at least 80 percent of the population at some point in their lifetime” is emphasizing something that may be intermittent or even acute for a few years and making it seem like it is constant. The actual prevalence of low back pain globally is about 8,500 cases for every 100,000 people, according to the University of Washington’s Institute for Health Metrics and Evaluation.
So, while it may technically be true that 80 percent of us will “at some point” experience low back pain, we feel like providing the actual prevalence of low back pain would be a more realistic context.
Further, this study focuses on those with back and leg pain due to a disc herniation. Disc herniations only represent a small fraction of patients with low back pain. Moreover, these patients had symptoms for more than 3 months. Most patients (around 75 percent) with a disc herniation improve over time without invasive treatment. So the actual population studied here is a fraction of the low back pain population that is mentioned in the title and the start of this piece.
It’s not obvious from the release who funded this work.
The release mentions that the study included 80 patients “experiencing at least three months of low back pain due to a herniated disk that had not responded to conservative treatments including exercise and medication.” But that’s an inadequate description of accepted alternatives. Patients with persistent pain due to a disc herniation have a number of well accepted alternative treatments including epidural steroid injections, surgical discectomy as well as other minimally invasive procedures.
The release does a nice job of explaining the procedure and, we feel, gives readers enough detail to understand how it would work. But it does not make it clear how widely this procedure is available and the type of technical skill necessary to administer it.
Novelty is not established in this release. If the authors had mentioned that there are other minimally invasive procedures and that their limitations led to this new technique, that would have established the novelty of this procedure. It’s not clear how the technique differs from other similar techniques or exactly how the low level energy reduces pain.
At one point, the lead investigator Alessandro Napoli, says, “The results have been extraordinary. Patients have been relieved of pain and resumed their normal activities within a day.” Can we really call these results extraordinary? As noted above, we are talking about results in just 65 patients over just one year.
There are a long list of treatments for low back disorders that initially reported results that sounded too good to be true, but weren’t.