PRP RCT in JAMA

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Ludicolo

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Those who get the Academy listserve emails are already in the know, but for you others:

De Vos RJ, et al. Platelet-rich plasma injection for chronic Achilles tendinopathy. A randomized controlled trial. JAMA 2010;303:144-9.

Context Tendon disorders comprise 30% to 50% of all activity-related injuries; chronic degenerative tendon disorders (tendinopathy) occur frequently and are difficult to treat. Tendon regeneration might be improved by injecting platelet-rich plasma (PRP), an increasingly used treatment for releasing growth factors into the degenerative tendon.

Objective To examine whether a PRP injection would improve outcome in chronic midportion Achilles tendinopathy.

Design, Setting, and Patients A stratified, block-randomized, double-blind, placebo controlled trial at a single center (The Hague Medical Center, Leidschendam, the Netherlands) of 54 randomized patients aged 18 to 70 years with chronic tendinopathy 2 to 7 cm above the Achilles tendon insertion. The trial was conducted between August 28, 2008, and January 29, 2009, with follow-up until July 16, 2009.

Intervention Eccentric exercises (usual care) with either a PRP injection (PRP group) or saline injection (placebo group). Randomization was stratified by activity level.

Main Outcome Measures The validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, which evaluated pain score and activity level, was completed at baseline and 6, 12, and 24 weeks. The VISA-A score ranged from 0 to 100, with higher scores corresponding with less pain and increased activity. Treatment group effects were evaluated using general linear models on the basis of intention-to-treat.

Results After randomization into the PRP group (n=27) or placebo group (n=27), there was complete follow-up of all patients. The mean VISA-A score improved significantly after 24 weeks in the PRP group by 21.7 points (95% confidence interval [CI], 13.0-30.5) and in the placebo group by 20.5 points (95% CI, 11.6-29.4). The increase was not significantly different between both groups (adjusted between group difference from baseline to 24 weeks, −0.9; 95% CI, −12.4 to 10.6). This CI did not include the predefined relevant difference of 12 points in favor of PRP treatment.

Conclusion Among patients with chronic Achilles tendinopathy who were treated with eccentric exercises, a PRP injection compared with a saline injection did not result in greater improvement in pain and activity.

And the laypress reporting:

http://www.nytimes.com/2010/01/13/health/13tendon.html?ref=health
 
interesting.:corny:

I've seen this described before as regenerative medicine
 
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The discussions on the listserve are certainly interesting😀
 
I am sad to see that the results for this study weren't that promising. Does this study have adequate power? I am not good with stats, but maybe that could be argued. The confidence intervals are a little wide. I am pretty certain it won't take long before this study gets done at a bigger scale.
 
how does one access these "listserv" discussions?
thanks

wondering if results would have been different had they used concentric rather than eccentric exercise, or even no exercise... isn't eccentric exercise more damaging to the muscles/tendons, although according to the newspaper article doing 180 reps of eccentric exercise is the only thing shown to help achilles tendonopathy.
 
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how does one access these "listserv" discussions?
thanks

wondering if results would have been different had they used concentric rather than eccentric exercise, or even no exercise... isn't eccentric exercise more damaging to the muscles/tendons, although according to the newspaper article doing 180 reps of eccentric exercise is the only thing shown to help achilles tendonopathy.

You have it backwards grasshopper. Eccentric exercise puts less strain across the tendon/bone junction, allowing greater strength gains with less trauma to the tendon.
 
I’m going to take off my EMG hat and put on my biomechanics hat for a minute. Forgive me but it’s kind of dusty.

Hemisphere – you may be confusing this concept with acute myotendinous injuries, e.g. hamstring tears, which result after a sudden large eccentric load. In a chronic tendinosis, we’re likely dealing with repetitive microtrauma/degeneration in the setting of age-related metabolic tissue changes and varying individual anatomy/biomechanics.

RUOkie - actually, I believe that peak tendon force is the same with either concentric or eccentric contraction. The difference, according to biomechanical studies, appears to be the presence of high-frequency oscillations (vibrations) in the tendon force during the eccentric loading phase. These tendon force vibrations happen to be absent during concentric or isometric contractions. Perhaps these oscillations have a positive effect on tendon remodeling, similar to the high frequency vibration effect on bone remodeling.

The concern with this study, to summarize the listserves, is that while the results are disappointing, they should not be interpreted as definitive. We don’t truly know what’s going on with this type of injury and its recovery/rehab at the cellular/metabolic level. The pathophysiology involved in Achilles tendinosis may be quite different from other tendinopathies or fasciopathies. Additionally, this study population isn’t really representative of our clinical population, in that very few of us would jump straight to PRP without attempting more conservative treatments first. Finally a significant concern raised is that 3rd party payers will be all over this study and quickly and absolutely deny any and all current and future attempts for reimbursement.

As with everything, more research needs to be done. The role of PRP and its place in the physiatric universe remains to be determined. And we (PM&R) should be the ones figuring it out.
 
I’m going to take off my EMG hat and put on my biomechanics hat for a minute. Forgive me but it’s kind of dusty.

Hemisphere – you may be confusing this concept with acute myotendinous injuries, e.g. hamstring tears, which result after a sudden large eccentric load. In a chronic tendinosis, we’re likely dealing with repetitive microtrauma/degeneration in the setting of age-related metabolic tissue changes and varying individual anatomy/biomechanics.

RUOkie - actually, I believe that peak tendon force is the same with either concentric or eccentric contraction. The difference, according to biomechanical studies, appears to be the presence of high-frequency oscillations (vibrations) in the tendon force during the eccentric loading phase. These tendon force vibrations happen to be absent during concentric or isometric contractions. Perhaps these oscillations have a positive effect on tendon remodeling, similar to the high frequency vibration effect on bone remodeling.

The concern with this study, to summarize the listserves, is that while the results are disappointing, they should not be interpreted as definitive. We don’t truly know what’s going on with this type of injury and its recovery/rehab at the cellular/metabolic level. The pathophysiology involved in Achilles tendinosis may be quite different from other tendinopathies or fasciopathies. Additionally, this study population isn’t really representative of our clinical population, in that very few of us would jump straight to PRP without attempting more conservative treatments first. Finally a significant concern raised is that 3rd party payers will be all over this study and quickly and absolutely deny any and all current and future attempts for reimbursement.

As with everything, more research needs to be done. The role of PRP and its place in the physiatric universe remains to be determined. And we (PM&R) should be the ones figuring it out.

You are absolutely correct, I was trying to be simplistic😳

I agree with you completely, but wish to look at this from the other side. In my 15 years since the start of residency, I have seen very expensive treatments for MSK conditions come and go (chymopapain, IDET, laser nucleoplasty etc.). Because of this I have become a skeptic, and refuse to jump on any bandwagon. Now there is this rise (again) in Prolotherapy, and there is no science to back it up, only theory. PRP is ridiculously expensive, and we are using it for treatment of tendinopathy!?

For elite atheletes, I can understand, but not the every day person. I do not think that 3rd party payors should pay for this stuff until it is PROVEN to work!, not thought to work.

I liken this to the use of IV bisphosphonates for tibial stress fractures. It works in runners. But if I get a stress fracture, should my insurance company pay for such an expensive infusion to quicken my recovery? I could just lay off running for a few months, change my mechanics, and cure. An elite runner, though, will miss an entire season doing that. So, he/she pays for it (or their sponsors/university etc.) to get back to training quicker.
 
As with everything, more research needs to be done. The role of PRP and its place in the physiatric universe remains to be determined. And we (PM&R) should be the ones figuring it out.

We had a meeting about this at the AAPMR meeting in Austin. The main issues were how to secure funding for these particular studies and how to pool data.

In general, our academic departments need to be more involved with the ortho departments on an outpt basis if we want to get this type of stuff done.
 
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