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.
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.
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.
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.
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.
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.
The release does not engage in disease mongering.
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.
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.
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.
The release identifies the study as the first randomized trial of a surgical procedure versus conservative,non-surgical care for SIJ dysfunction.
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.