Novel Tendon Shots Offered No Benefit over Exercise (CME/CE, with audio)

An experimental drug-and-exercise therapy for chronic Achilles tendinopathy didn’t work in a Dutch study, researchers said.

Injections of platelet-rich plasma (PRP) combined with eccentric exercise gave no better results than exercise alone, according to Robert de Vos, MD, of Erasmus University Medical Center in Rotterdam, and colleagues.

The finding comes from the first randomized, placebo-controlled trial of the therapy, which appears to be gaining popularity on the basis of more limited studies, De Vos and colleagues reported in the Jan. 13 Journal of the American Medical Association.

The popularity of the treatment has also been fueled by its connection to professional athletes, most notably golfer Tiger Woods, who reported received PRP injections last year to speed his recovery from knee surgery.

The theory behind the practice is that the platelets lead to a release of growth factors that participate in tissue repair.

But support for the theory has been based on laboratory studies and clinical trials that had “important limitations,” the researchers said, including lack of a control group or blinding procedure.

To fill the gap, de Vos and colleagues enrolled 54 patients being treated at The Hague Medical Center for chronic tendinopathy two to seven centimeters above the Achilles tendon insertion.

They were randomly assigned to get injections of PRP derived from their own venous blood or a saline placebo, combined with 12 weeks of eccentric exercises. The investigators noted that platelet-rich plasma injections are generally performed now in association with exercise programs.

The primary endpoint was change from baseline to six, 12, and 24 weeks on the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, which evaluates pain score and activity level.

The fluid — saline or plasma — was injected through three ultrasound-guided punctures in the tendon. Through each puncture, five small depots of fluid were left in the damaged area of the tendon, the researchers reported.

Based on the questionnaire, both groups improved significantly from baseline through 24 weeks. Those getting plasma improved by 21.7 points, while those getting saline placebo improved by 20.5 points.

There was no significant difference between the groups at 24 weeks or at any other evaluation time point, the researchers found.

The improvement in both groups can probably be attributed to the exercise program, the researchers said, although part of it might be due to a placebo effect among those getting saline.

One limitation of the study, the researchers said, is that the number of platelets and the quantity of growth factors in the injections was not known.

It is also not clear how long such growth factors remained in the tendon; there is a possibility that they might have diffused away rapidly, lessening their effect, the authors noted.

Such limitations mean it’s too early to junk the idea entirely, according to Victor Ibrahim, MD, of the National Rehabilitation Hospital in Washington, D.C., who was not part of the study.

It may be, he told MedPage Today, that the exercise component of the study in effect squeezed the active factors out of the tendon. It may also be that the injection protocol, while “reasonable,” was not the most effective one, he said.

Patients have begun to regard PRP as a “miracle cure,” Ibrahim said, but the study implies that the “foundations of recovery need to be rehabilitation.”

“A good therapy program really beats out anything that we have so far when it comes to injections, whether it’s steroids or platelet-rich plasma,” he said.

The study was supported by by Biomet Biologics of Warsaw, Ind.

The researchers reported no conflicts.

source : www.medpagetoday.com

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