Our Review Summary
This news release summarizes a recently published paper on a randomized trial of sacroiliac joint fusion (SJF) using titanium implants versus non-surgical therapy for treating sacroiliac joint dysfunction (SJD), an inflammation of the joints connecting the lower spine and pelvis.
The study included 148 patients with chronic low back pain caused by SJD who were treated at 19 U.S. spine surgery clinics.
While the study was funded and staffed by the manufacturers of the implant, the release doesn’t overtly hype the surgical procedure or promote the manufacturer. However, failure to point out the trial design’s potential bias and the inadequate discussion of harms were weaknesses, according to our reviewers.
Why This Matters
Chronic low back pain is a common cause of disability in the United States and available treatments have not been associated with a cure or even major long-term relief for most individuals. Attempts to identify specific causes of the pain have also met with limited success. One potential pain generator is the sacroiliac joint (SIJ). In recent years, considerable research has helped identify those patients with chronic low back pain due to the SIJ and then to offer treatments. Few high quality studies have compared treatments for patients thought to have pain due to the SIJ.
SJF is becoming a widely used treatment for a condition that poses chronic pain and disability in its sufferers. A minimally invasive treatment for SJD that has a reasonable success rate and is safe is desirable as a treatment option.
Criteria
Not Satisfactory
The release doesn’t discuss costs for the implant procedure. Although “minimally invasive,” surgical treatment options can still run into tens of thousands of dollars. Not all insurance providers cover SJF procedures. Some cover it for certain conditions but not others. The procedure was recently approved for coverage by Medicare and by Medicaid in some states.
Satisfactory
The release cited the primary outcome of the implant procedure in terms of an absolute percentage.
Using reduction in pain and absence of complications at 6 months as the primary outcome, “treatment was rated successful in 81 percent of subjects assigned to the SIJ implant procedure, compared to 26 percent with nonsurgical treatment,” according to the release. In addition, the average pain score decreased to 30 in the surgical group versus 72 in the nonsurgical group. “Seventy-three percent of subjects undergoing the implant procedure had “clinically significant” reduction in disability scores, compared to just 14 percent in the nonsurgical group.”
We thought that the release’s implication that it is easy to figure out who has chronic pain due to SI joint inflammation was inadequate. In practice, it is very difficult to diagnose patients with sacroiliitis and it’s often mistaken for other types of back pain, as the study itself indicates.
Not Satisfactory
Some harms are mentioned but in insufficient detail. The published study cites a small number of serious complications. Although the adverse events are rare, they should still be mentioned. The most common side effects among those receiving the procedure were leg and pelvic pain within the first year, according to the study.
Satisfactory
We thought the release should have explained why there were twice as many patients in the surgical group compared to the group receiving non-surgical treatment. Normally, a randomized trial aims to have equal numbers in each group.
The release would have benefited from mentioning this was an unblinded study and thus subject to observer bias, among other types of bias.
The published study stated that “At baseline, 67.6% and 63% of SIJ fusion and NSM [non-surgical management] subjects were taking opioid analgesics for SIJ or lower back pain. By month 6, the proportions were 58.4% and 0.5%, representing a 9% decrease in use for the fusion group and a 7.5% increase in the NSM group (P = .08). ” Although surgical patients were said in the release to have dramatic improvement at 6 months post-surgery, according to the published study, only 9% had stopped using opiate pain medicines. In addition, almost all non-surgical patients crossed over to surgery after 6 months, again suggesting that there may be a strong bias towards surgery.
All this said, we thought the release deserved a satisfactory for its presentation of the evidence. The release adequately disclosed some trial limitations, notably that there was a lack of long-term outcomes in the nonsurgical group due to the high crossover rate and that future analysis will look at two-year follow-up CT scans and the cost-effectiveness comparison of SIJ fusion versus nonsurgical treatment.
Satisfactory
The release does not engage in disease mongering.
Not Satisfactory
The news release states early on that the research was funded by the company that makes the titanium implant but doesn’t mention that the researchers were either employees or consultants to the company. At a minimum, the release should state what sort of financial relationship the authors had with the company.
Satisfactory
The release lists alternative therapies for SJD which include “physical therapy, steroid injections and/or radiofrequency ablation of sacral nerve root lateral branches” as well as the therapy compared in the trial.
Satisfactory
Because the study involved 19 U.S. sites we know there are a number of medical institutions capable of performing the implant. In addition, the release states that the procedure is FDA approved.
Satisfactory
The release identifies the study as the first randomized trial of a surgical procedure versus conservative,non-surgical care for SIJ dysfunction.
Not Satisfactory
There were several instances of careless language in the release including the phrases: “clinically and statistically important” improvements in clinical outcomes for patients and “profound differences” between the surgical and nonsurgical groups. “Profound” is in the category of “breathtaking” and is inappropriate in a news release.
In addition, the claim that the procedure “Produces significant and lasting improvements in pain, disability, and quality of life” is not justified. Even the study authors acknowledged that it is unclear how these improvements will look in the long term.
Total Score: 6 of 10 Satisfactory
Comments (3)
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Jerry Hesch MHS, DOT
October 29, 2015 at 8:29 pmVery relevant rating data. Another abused term in these types of marketing “studies” is the term “based on good clinical studies”. Code/speak it is.
Mark Schoene
November 2, 2015 at 10:07 amWould argue that this press release deserves a much lower score. And that the RCT it describes is nearly uninterpretable—which the press release and HNR review should have indicated.
The treatment of pain attributed to the SIJ joint is one of the latest fads in low back pain—an example of the overuse of diagnostic and treatment interventions in the absence of high-quality scientific evidence.
Here is an example of the HNR review over-scoring the press release. The HNR review suggests the press release did not engage in disease-mongering.
Yet the press release clearly does, with the statement “Sacroiliac joint dysfunction is a common cause of disabling pain in the lower back, buttocks, or groin.” Says who?
Given current diagnostic abilities, it is not possible to attribute low back pain to the sacroiliac joint in the absence of serious pathology. The SIJ joint is a possible cause of chronic back pain but not a proven one. The statement in the press release is simply speculation. But worrisome speculation for people with nonspecific low back pain wondering if they might have SIJ problems.
Neither physical testing nor SIJ blocks have ever been validated as diagnostic methods for possible SIJ pain. There is no “gold standard” against which to compare the results of these tests—and their usefulness has never been mapped out in rigorous long-term outcome studies. (See Szadek KM, J Pain, 2009; Chou, APS review, Spine, 2009)
Why would the results of the RCT be nearly uninterpretable? The use of unvalidated diagnostic tests to recruit patients to the study (not clear that anyone in this study had SIJ pain); overlapping diagnostic groups, the atypical definition of “intention-to-treat” analysis; using six-month outcomes as the primary clinical study endpoint (a minimum of two years is standard in spine surgery), allowance of crossovers at six months, and, most importantly, an extensive crossover rate rendering all long-term comparisons of surgery vs. nonsurgical care meaningless (there were only nine subjects left in the nonsurgical group at 12 months.)
Thanks to HNR for bringing this important study and press release to public attention.
With Best Regards,
Mark Schoene
Editor, The BackLetter
Consumer Representative
Cochrane Collaboration Back and Neck Group
Kevin Lomangino
November 5, 2015 at 1:37 pmMark,
Thanks for these great comments that are obviously based on a close read of the study and the news release.
The review team agrees with many of the points that you made, but we think it’s important to draw a distinction between the news release and the underlying study. We are reviewing the news release, not the study.
So when you say that the RCT that the news release was based on is “uninterpretable” and that “the press release … should have indicated” this, we think that’s going too far. News releases are promotional documents, and while we can expect responsible news release writers to call attention to key limitations in a study, we wouldn’t expect them to trash the document they are promoting — which is the work product of the institution where they are employed.
Our review highlighted some problems with the news release, including the fact that it downplays potential for bias in the study. But the news release also calls attention to some key limitations, including the high crossover rate that you mentioned as well as the lack of long-term outcomes. Again, we think it’s unreasonable to expect the news release to run down every potential problem with the study methodology, and while we perhaps could have mentioned more of those concerns, our intent is to provide constructive feedback rather than bludgeon news release writers with criticism.
Thanks again for reading and engaging with us.
Kevin Lomangino
Managing Editor
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