SLR - September 2014 - Randy Garr
Reference: Maffulli N, Spiezia F, Longo UG, Denaro V. High Volume Image-Guided Injections for the Management of Chronic Tendinopathy of the Main Body of the Achilles Tendon. Physical Therapy in Sport 14 (2013) 163-167.Scientific Literature Review
Reviewed By: Randy Garr, DPM
Residency Program: Puget Sound Health Care System
Podiatric Relevance: The purpose of this prospective study was to show that high volume image guided injections (HVIGI) were safe and largely effective for treatment of chronic recalcitrant tendonopathy of the main body of the Achilles tendon, specifically when addressing the patient that has failed other less invasive conservative treatment and is considering surgical intervention.
Methods: This was a series report of 94 athletes with ultrasound confirmed tendonopathies of the main body of the Achilles tendon. All patients has failed at least three months of eccentric rehabilitation and had received a variety of conservative management including modifications of activities, extracorporeal shock wave therapy, massage, ultrasonotherapy, hyperthermia, and laser therapy. Many had also been immobilized in a cast or walker for 4-9 weeks, and most had received a corticosteroid injection previously. Patients were injected with 10cc of 0.5 percent bupivacaine hydrochloride, 25mg aprotinin, and up to 40cc of injectable normal saline. Victorian Institute of Sport Assessment—Achilles tendon (VISA-A, 1-100, 100 is completely asymptomatic) was administered prospectively to assess improvement in pain and function with follow up extending to 12 months.
Results: VISA-A scores improved greatly from the baseline median of 41.7 to 74.6 at 12 months. The mean neovascularization grade at presentation was three, and the maximal tendon thickness was 9.1mm. At the final follow up, mean neovascularization grade was two and tendon thickness was 7.3, both of which were statistically significant, however, there was no association shown with the decrease in neovascularization grade or the decreased tendon thickness, with improvement in VISA-A scores. By the end of the 12 months, 61 (68 percent) patients had returned to performing their sport at their desired level (19 of these did undergo a second HVIGI, secondary to continued pain two weeks after 1st injection). Ten patients, at a lower then desired level (9 after 2nd injection). Eight patients were not able to return to their sport. Finally, another eight patients had undergone surgery for failure to improve after receiving 1st and 2nd round of HIVGI.
Conclusions: The authors of this article conclude that HIGVI seems to be a reasonable, minimally invasive, treatment those patients with chronic recalcitrant tendonopathy of the main body of the Achilles tendon, before considering surgical intervention. This conclusion is made, but is not actually supported by the construct of the study or its’ results. There were several flaws in the construct of the study as well as their conclusion. First, and foremost, the aprotinin that was used initially in the study was taken off the market due serious risk of thrombus formation and organ failure. The subsequent injections were done with corticosteroid, which have their own risk profile, most notably for increased risk of tendon rupture. Second, the author’s conclusion that the benefit of the injections due to the mechanical effect of the “high volume”, as opposed to the substance in the injection, is an untested hypothesis that the study was not constructed to test. Third, there were many participants in the study that appear to have been lost to follow, but are not at all accounted for in the statistics. A series of 94 athletes is misleading at best, as the final results include only 59 of the patients that had a successful follow up ultrasound. This also questions, how reliable their ultrasound and/or technician were, secondary to the high number of participant’s ultrasound exams are considered “unsuccessful.” It is difficult to support their claim of almost 70 percent success rate of these HIGVI when there are so many uncontrolled variables, a lack of consistency of study medications throughout the study, no control group, and unreliable ultrasound examinations. Although this article has many faults, it does do well in raising a valid question or hypothesis, regarding the volume of the injection having a greater impact on success than what medications was used. Perhaps with a better thought out and constructed prospective trial, the mechanical effect and benefit of high volume injection of saline with or without ultrasound guidance would show favorable results for this common pathology of chronic Achilles tendonopathy.