The Journal of Orthopaedic and Sports Physical Therapy (JOSPT) is an academic, peer-reviewed journal that has been in print since 1979. According to JOSPT, its mission statement is to “publish scientifically rigorous, clinically relevant content for its members and the healthcare community to advance musculoskeletal and sports-related practice globally”. Evidently, JOSPT has nearly 22,000 print-subscribers and over 114,000 digital users.
According to JOSPT, subscribers “routinely act on advertisements seen in JOSPT, with 68% visiting the company’s website, 43% recommending the purchase of a product, 39% discussing an advertisement, 34% contacting an advertiser, and 31% buying the advertised product.” Therefore, it is important for the one third of subscribers who are apparently buying the products advertised in JOSPT to recognize the following.
1. Although JOSPT is an academic, peer-reviewed journal interested in the publication of high-quality clinical trials that advance musculoskeletal and sports-related practice, it is not free from actual monetary conflicts of interest. More specifically, JOSPT is receiving payments from the developers/manufacturers of medical devices in return for advertising their “efficacy” in the journal.
2. The notion that if JOSPT is advertising a product or device, then it must work, is false.
3. JOSPT appears very willing to take large sums of advertising dollars from the manufacturer of a medical device that has yet to be proven effective (through high-quality, randomized clinical trials by authors that are NOT paid by the developer/manufacturer).
More specifically, JOSPT is getting paid to advertise the Iovera device (manufactured by Myoscience, Inc., Fremont, CA) as an effective treatment for individuals with knee OA. The device claims to create a “cold zone” from the Joule-Thompson effect by the flow of “cryogen” (nitrous oxide) from a disposable cartridge through a hand-piece to a “Smart Tip”—an assembly of three 27-gauge closed-end needles. Nothing is injected in the body. The authors classify the Iovera device as a form of “cryoneurolysis”. The target nerve in this study is the infrapatellar branch of the saphenous nerve, which is supposedly cooled to the point of significantly relieving the pain and disability in patients with knee OA. Perhaps it does work as claimed, but how long does this apparent effect last?
This $5000 device ($1950 for an individual clinic versus $5000 for a hospital-affiliated clinic; plus $390 in disposable “cryogen” cartridges and “Smart Tip” needles per episode of care) is currently being advertised on the homepage of JOSPT’s website, on the front inside cover of the printed JOSPT publication, and digitally through mass emails to its subscribers (primarily to physical therapists, athletic trainers, and chiropractors).
Notably, JOSPT does have some fine print at the top of their mass emails acknowledging that “JOSPT does not endorse the products and services of its advertisers”. However, the Iovera advert on the front inside cover of JOSPT (see the image above of the Iovera advert on the front inside cover of the JOSPT) does not disclose (anywhere!) that JOSPT is getting paid to push this device and whether or not JOSPT endorses the use of this device. We believe this to be misleading to the reader of JOSPT, especially when you consider that 31% of JOSPT subscribers apparently purchase the products from the adverts in JOSPT.
In the emails sent from JOSPT to 114,000 healthcare providers, Pacira Pharmaceuticals cites a single research study1 to support the following claims for the Iovera device:
1. “Provides immediate and long-lasting OA knee pain relief”
2. “54% reduction in knee pain at day 30”
3. “Significant improvements in physical function demonstrated at days 30, 60 and 90”
We do not believe this is an accurate representation of the findings of this study.1 Specifically, the claim of “long-lasting OA pain relief” is false. “Long-lasting” implies long-term, and long-term is typically associated with 6-month or 12-month outcomes in clinical trials. Yes, Radnovich et al1 reported significant between-group improvements at day 30 (P=0.0004), day 60 (P=0.0176), and day 90 (P=0.0061) in knee pain (as measured by the WOMAC pain subscale score); however, the following findings, inconsistencies and financial conflicts of interest should be considered when interpreting the results of this trial:
1. The lead author, Dr. Radnovich, is a paid consultant of Myoscience—the company behind the development, ownership, and manufacturing of the Iovera device. In addition, one of the co-authors of this study (Dr. Dasa) is a paid speaker for and owns stock options in Myoscience. Yes, these competing interests are disclosed at the end of the published clinical trial, however, JOSPT makes no mention of this when they run a full-page advertisement on the front inside cover of JOSPT claiming the Iovera device to be an effective treatment for knee OA. On that same page of the in-print advert and the online advert, JOSPT should state the following: 1) the authors of the published trial were paid by the manufacturer/owner of the device, and 2) that they themselves (i.e., JOSPT) were paid by the manufacturer of the device to run the advert in JOSPT.
2. The primary outcome measure (i.e., knee pain as measured by the WOMAC pain subscale score) showed no significant (P=0.161) between-group difference (cryoneurolysis versus sham treatment) at the longest mandatory outcome point (i.e., day 120) that was taken for all patients in both groups.
3. For the WOMAC total scores, the responder rate for the treatment group and the sham group was not significantly different at day 120 (P=0.400).
4. Although a secondary outcome, the between-group difference for knee pain (as measured by the VAS) was statistically different at day 30 (P=0.0073), but not at day 60 (P=0.185), day 90 (P=0.183) or day 120 (P=0.289).
5. Although secondary outcomes, but at the longest mandatory outcome point taken in all subjects in both groups, the between-group difference at day 120 for WOMAC stiffness (P=0.152), WOMAC physical function (P=0.162), and WOMAC total (P=0.163) scores were not significantly different.
6. According to the patients themselves (as measured by the Global Rating of Change), there was no significant difference between the cryoneurolyis treatment group and the sham treatment group in the proportion of responders at any of the follow-up assessments.
7. None of the changes in pain reported in the trial translated into statistically significant changes in overall health-related qualify of life (as measured by the SF-36).
8. In the published trial, the authors reported the study began in April 2013; however, the trial registry (clinicaltrials.gov NCT02260921) states the actual study start date was October 20, 2014. This is an 18-month discrepancy.
9. A total 243 adverse events in 113 of the 180 patients occurred during the study; notably, 84 of these adverse events were deemed “possibly or probably related to the device or procedure”.
For decades, physical therapists, and other healthcare providers alike, have trusted what we see and read in JOSPT to be relevant for the advancement of musculoskeletal and sports-related practice. However, over the past several weeks, we have had numerous calls and emails from a variety of healthcare providers (mainly PTs, ATs, and DCs) asking us whether the Iovera machine is a gimmick or a device that clinicians should be purchasing for use in their clinics.
In short, and as detailed above, based on the actual findings reported in the 2017 cryoneurolysis study by Radnovich et al1, we don’t believe the statements made in the JOSPT adverts (both the in-print and online versions) to be accurate regarding the “long-lasting pain relief” the Iovera device claims to provide in patients with knee OA.
Therefore, given the perceived status of JOSPT as an unbiased and peer-reviewed academic journal, we call for JOSPT to either (1) include full disclosure on ALL advertisements—i.e., let the reader know JOSPT is getting paid by the developer/manufacturer of this device and that they do not endorse the product, or (2) stop advertising devices to healthcare providers that are clearly not yet supported by high-quality clinical trials and where the authors of such clinical trials are paid consultants by the manufacturer (and stock owners) of the device.
AUTHORS
Andrew Cook, PT, DPT, Cert. DN
CEO, Mobility Fit Physical Therapy, Cincinnati, OH
Fellow-in-training, AAMT Fellowship in Orthopaedic Manual Physical Therapy
Clint Serafino, DPT, FAAOMPT, Dip. Osteopractic
Senior Instructor, American Academy of Manipulative Therapy
Assistant Director, AAMT Fellowship in Orthopaedic Manual Physical Therapy
James Dunning, PhD, DPT, MSc, FAAOMPT, Dip. Osteopractic
President, American Academy of Manipulative Therapy
Director, AAMT Fellowship in Orthopaedic Manual Physical Therapy
Owner, Montgomery Osteopractic Physical Therapy & Acupuncture, Montgomery, AL
REFERENCES
1. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. Aug 2017;25(8):1247-1256. doi:10.1016/j.joca.2017.03.006
OSTEOPRACTIC 