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Ajs355445_web 255.262The American Journal of Sports Positive Effect of an Autologous Platelet Concentrate in Lateral Epicondylitis in a Double-Blind
Joost C. Peerbooms, Jordi Sluimer, Daniël J. Bruijn and Taco Gosens Am J Sports Med The online version of this article can be found at: can be found at:
The American Journal of Sports Medicine
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Positive Effect of an Autologous PlateletConcentrate in Lateral Epicondylitis ina Double-Blind Randomized Controlled Trial Platelet-Rich Plasma Versus Corticosteroid InjectionWith a 1-Year Follow-up Joost C. Peerbooms,* MD, Jordi Sluimer,y MD, Danie¨l J. Bruijn,* PhD, and Taco Gosens,yz PhDFrom the *Department of Orthopaedic Surgery, HAGA Hospital, The Hague, Netherlands, andyDepartment of Orthopaedic Surgery, St Elisabeth Hospital, Tilburg, Netherlands Background: Platelet-rich plasma (PRP) has shown to be a general stimulation for repair.
Purpose: To determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateralepicondylitis.
Study Design: Randomized controlled trial; Level of evidence, 1.
Patients: The trial was conducted in 2 teaching hospitals in the Netherlands. One hundred patients with chronic lateral epicon-dylitis were randomly assigned in the PRP group (n 5 51) or the corticosteroid group (n 5 49). A central computer system carriedout randomization and allocation to the trial group. Patients were randomized to receive either a corticosteroid injection or anautologous platelet concentrate injection through a peppering technique. The primary analysis included visual analog scoresand DASH Outcome Measure scores (DASH: Disabilities of the Arm, Shoulder, and Hand).
Results: Successful treatment was defined as more than a 25% reduction in visual analog score or DASH score without a rein-tervention after 1 year. The results showed that, according to the visual analog scores, 24 of the 49 patients (49%) in the corti-costeroid group and 37 of the 51 patients (73%) in the PRP group were successful, which was significantly different (P .001).
Furthermore, according to the DASH scores, 25 of the 49 patients (51%) in the corticosteroid group and 37 of the 51 patients(73%) in the PRP group were successful, which was also significantly different (P 5 .005). The corticosteroid group was betterinitially and then declined, whereas the PRP group progressively improved.
Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and significantly increases function,exceeding the effect of corticosteroid injection. Future decisions for application of the PRP for lateral epicondylitis should be con-firmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.
Keywords: lateral epicondylitis; platelet rich plasma; corticosteroids; pain; function Lateral epicondylitis is the most commonly diagnosed con- are at high risk. The dominant arm is most frequently dition of the elbow, affecting approximately 1% to 3% of the population. The condition mostly occurs in patients whose The cause of lateral epicondylitis is unknown. It is activities require strong gripping or repetitive wrist move- thought that lesions occur in the common origin of the ments. Individuals between the ages of 35 and 50 years wrist and finger extensors on the lateral epicondyle owingto a combination of mechanical overloading and abnormalmicrovascular responses.12,19,24 Numerous methods have been advocated for treat- ing elbow tendinosis, including rest, nonsteroidal anti- Address correspondence to Taco Gosens, PhD, St Elisabeth Hospital, Hilvarenbeekseweg 60, Tilburg, 5022 GC, Netherlands (e-mail: t.gosens@ inflammatory medication, bracing, physical therapy, extracorporeal shock wave therapy, and botulism toxin No potential conflicts of interest declared.
injection. Injection of corticosteroids (once consideredthe gold standard but now controversial), whole blood The American Journal of Sports Medicine, Vol. 38, No. 2 injections, and various types of surgical procedures DOI: 10.1177/0363546509355445Ó 2010 The Author(s) The American Journal of Sports Medicine In an animal model, the addition of growth factors to the determined by using the results of Mishra and Pavelko.10 ruptured tendon has been shown to increase the healing of In this study, 93% of the patients with chronic lateral epicon- the tendon.1,11 In humans, it has been shown that the injec- dylitis that received PRP were considered successful—that tion of whole blood into the tendon decreases the pain.3 is, with more than a 25% decrease in pain. Successful treat- Platelet-rich plasma (PRP) is promoted as an ideal ment in the control group was determined by using the autologous biological blood-derived product that can be results of Hay and colleagues,6 who studied the effect of cor- exogenously applied to various tissues, where it releases ticosteroid injections for chronic lateral epicondylitis. Full high concentrations of platelet-derived growth factors recovery or decrease in complaints without complications that enhance wound healing, bone healing, and tendon was seen in 65% of the patients in the corticosteroid group.
healing.14 In addition, PRP possesses antimicrobial proper- With a bilateral alpha of .05 and a power of 90% (p1 5 ties that may contribute to the prevention of infections.5 .93 and p2 5 .65), 42 patients per group are necessary to When platelets become activated, growth factors are measure the difference with the chi-square test. To correct released and initiate the body's natural healing response.
for the patients who where lost to follow-up, we included In a double-blind randomized trial, we investigated a minimum of 50 patients in each group. The Medical- whether injection of concentrated autologous platelets Ethical Committee and the National and Institutional improves the outcome of patients with lateral epicondylitis Review Board approved the study.
more so than corticosteroid injection. The primary outcomeparameters were pain and daily use of the elbow.
Randomization was performed after patients were deemed eligible and had provided informed consent. Patients wererandomly allocated to the concentrated autologous platelet This double-blinded randomized trial included 100 consec- group (PRP group) or the corticosteroid group (control utive patients with lateral epicondylitis scheduled for group). A computer using block randomization of 10 injection therapy in 2 Dutch training hospitals between patients was used to create a randomization schedule.
May 2006 and January 2008.
Treatment assignments (placed in sequentially numbered All procedures used the same injection procedure, per- opaque envelopes) were assigned by the trial managers, formed by an orthopaedic consultant or a supervised ortho- who also arranged the facilities needed for the procedure.
paedic resident. Criteria for participation included lateralepicondylitis for longer than 6 months and pain of at least50 on a visual analog score (VAS) for pain (0, no pain; 100 maximum pain possible). Lateral epicondylitis was definedas pain over the lateral epicondyle on direct palpation and In the group randomized to receive PRP, the patient's own pain in that area during resisted wrist extension. All platelets were collected with the Recover System (Biomet affected elbows were screened with radiography and all Biologics, Warsaw, Indiana). This device uses a desktop- proved to be normal, except for some calcifications of the size centrifuge with disposable cylinders to isolate the common extensor origin. Sonography and magnetic reso- platelet-rich fraction from a small volume of the patient's nance imaging were not standardly used. Patients had anticoagulated blood, drawn at the time of the procedure.
a clinical diagnosis of lateral epicondylitis, or lateral elbow As part of the double-blind procedure, blood was also pain increased by pressure on the lateral epicondyle and collected from the patients in the control group. In sum, during resisted extension of the wrist. All patients suffered 27 mL of whole blood was collected from the uninvolved for more than 6 months. Before 6 months of the trial, they arm into a 30-mL syringe that contained 3 mL sodium were treated with cast immobilization, injections with cor- citrate. The platelet-rich fraction was prepared according ticosteroids, or physiotherapy.
to the instructions of the Recover System. Approximately Exclusion criteria were as follows: age less than 18 3 mL PRP was obtained for each patient. The PRP was years, pregnancy, history of carpal tunnel syndrome or cer- then buffered to physiologic pH using 8.4% sodium bicar- vical radiculopathy, and systemic disorders such as diabe- bonate, and bupivacaine hydrochloride 0.5% with epineph- tes, rheumatoid arthritis, and hepatitis. Also, patients rine (1:200000) was added. No activating agent was used.
were excluded if they had been treated for lateral epicondy- After masking the tubes with opaque tape, the investigator litis with surgical intervention or with a corticosteroid returned and injected 3 mL of this PRP into the patient.
injection in the past 6 months.
The total time from blood draw to injection in the patients The primary endpoint was a 25% reduction in the VAS was about 30 minutes. No specialized equipment was score or DASH Outcome Measure score (DASH: Disabil- required, other than the centrifuge to process the Recover ities of the Arm, Shoulder, and Hand) without a reinterven- disposable cylinders. All the procedures were performed in tion after 1 year. In the current study, we tested the the same office setting by an independent person certified hypothesis that the injection of concentrated autologous for blood management, without the investigator or the platelets increases the healing of patients with tendinitis patient present.
compared with those treated with a steroid injection.
Injection Technique. Approximately 1 mL of PRP or cor- Statistical data were collected to determine the power of ticosteroids (kenacort 40 mg/mL triamcinolon acetonide) both groups. Successful treatment in the PRP group was hydrochloride 0.5% with epinephrine Vol. 38, No. 2, 2010 Platelet-rich Plasma Versus Corticosteroid Injection allocated to treatment Lost to Follow-up Lost to Follow-up Operation (n = 3), Re-injection (n = 2) Operation (n = 6), Re-injection (n = 7) Figure 1. Flow diagram of a trial of injection therapy for chronic lateral epicondylitis. The diagram includes the number of patientsactively followed up at different times during the trial.
(1:200000) was injected directly into the area of maximum are compared with the t test. The VAS and DASH scores tenderness. Then, using a 22-guage needle and a peppering are compared with an analysis of variance with repeated technique, the investigator injected the remaining PRP or measurements test. The significance level was set at P 5 corticosteroids with bupivacaine hydrochloride 0.5% with .05 for all tests, and SPSS 16.0 was used.
epinephrine (1:200000, 6 4 mL) into the common extensortendon. This technique involved a single skin portal and 5penetrations of the tendon.
Postprocedure Protocol. Immediately after the injection, the patient was kept in a supine position without moving From May 2006 to January 2008, a total of 100 eligible the arm for 15 minutes. Patients were sent home with patients with lateral epicondylitis were randomized into instructions to rest the arm for approximately 24 hours.
groups. Eight patients were lost to follow-up or had incom- If necessary, patients were allowed to use acetaminophen, plete data sets; however, they needed no reintervention (Fig- but the use of nonsteroidal anti-inflammatory medication ure 1). Their data are included in the analysis until their last was prohibited. After 24 hours, patients were given a stan- visit. Analysis of the demographics (sex, side, and center) dardized stretching protocol to follow for 2 weeks under between the protocol-compliant patients and those lost to the supervision of a physiotherapist. A formal eccentric follow-up showed no significant differences (Table 1).
muscle- and tendon-strengthening program was initiated The mean patient age was 47 years. There were 48 men after this stretching. At 4 weeks after the procedure, and 52 women. The study included 63 patients with lateral patients were allowed to proceed with normal sporting or epicondylitis on the right elbow and 37 patients with symp- recreational activities as tolerated. The VAS and DASH toms on the left elbow. The ratio between dominant and function scores were measured before injection and at 4, nondominant side was according to the literature: 65%.
8, 12, 26, and 52 weeks after injection. The DASH score In most cases, the dominant side was involved.23 The ratio is a validated upper limb functional score.22 was equally distributed. The activity level of the patients,preintervention and postintervention, has been noted inthe DASH score.
Statistical Analysis Eighteen patients needed a reintervention. The patients who needed a reintervention were all scored as nonsuccessful.
All data analysis was carried out according to a preestab- Between the 2 hospitals, there were no significant differences lished analysis plan, on a last-observation-carried-forward between the protocol-compliant patients and the reinterven- basis. The categorical values are compared with the Pear- tion patients (P 5 .168). The primary analysis was conducted son chi-square test. The preoperative continuous variables ed-forward principle and involved 100 patients.
The American Journal of Sports Medicine Patient Demographics Flow Chart of Patients Platelet-Rich Plasma Free of complications Sex: male, female Side: right, left Lost to follow-up Corticosteroid injection (second injection) Platelet concentrate injection bChi-square test.
(second injection) Lost to follow-up In total, 18 reinterventions or operations were needed after an average of 5 months (range, 2-6 months). In thePRP group, 3 patients obtained an operation and 2 patients Six months after the procedure, PRP-treated patients a reinjection with corticosteroids. In the corticosteroid reported a mean improvement of 53.5% (70.1 to 32.6) in their group, 6 patients required an operation, 1 a reinjection VAS scores compared with the initial values, whereas the with corticosteroid, and 6 a reinjection with PRP after 6 corticosteroid-treated patients reported a 14.0% improve- months of follow-up (Table 2). The percentages of reinter- ment (65.8 to 56.6; P .001) (Figure 2). Also, after 6 months, vention did not depend on age, gender, side, treatment, DASH scores had improved 50.7% (161.3 to 79.5) in PRP or preoperative VAS or DASH score.
patients versus a 10.7% improvement (131.3 to 117.3) in Six months after the initial treatment, the patients who corticosteroid-treated patients (P 5 .003) (Figure 3).
were operated had VAS and DASH scores (respectively, One year after the procedure, PRP-treated patients 54.3 6 26 and 112.2 6 75.2) that were significantly worse reported a mean improvement of 63.9% (70.1 to 25.3) in than those of the nonoperated patients (P 5 .04). The their VAS scores compared with the initial values, whereas patients needing a second injection had comparable VAS patients reported a 24.0% and DASH scores (60.6 6 29 and 94.6 6 62.2; P 5 .0196) improvement (65.8 to 50.1; P .001) (Figure 2). Also, after as the patients who did not have a second injection.
1 year, DASH scores improved 66% (161.3 to 54.7) in PRP Initially, the PRP-treated patients had a mean VAS patients versus a 17.4% improvement (131.3 to 108.4) in score of 70.1 6 15.1 and a mean DASH score of 161.3 6 corticosteroid-treated patients (P 5 .001) (Figure 3).
62.3. The control patients had a mean VAS score of Regarding the patients who failed their treatment, those 65.8 6 13.8 and a mean DASH score of 131.2 6 58.2.
who crossed over to the PRP group and those who received Four weeks after the procedure, PRP-treated patients surgery did finally benefit. The patients who received a rein- reported a mean improvement of 21% in their VAS jection with corticosteroids did not see a resolution of pain scores (70.1 to 55.4) compared with the initial values, and disability, according to the mentioned criteria.
whereas the corticosteroid-treated patients reported Successful treatment was defined as more than a 25% a 32.8% improvement (65.8 to 44.2; P 5 .077) (Figure reduction in VAS or DASH score without a reintervention 2). Also, after 4 weeks, DASH scores had improved after 1 year. The results showed that 24 of the 49 patients 15.7% (161.3 to 135.9) in PRP patients versus a 25.8% (49%) in the corticosteroid group and 37 of the 51 patients improvement (131.3 to 97.4) in corticosteroid-treated (73%) in the PRP group were successful with the VAS score, patients (P 5 .469) (Figure 3).
which was significant (P .001). Twenty-five of the 49 Eight weeks after the procedure, PRP-treated patients patients (51%) in the corticosteroid group and 37 of the 51 reported a mean improvement of 33.1% (70.1 to 46.9) in patients (73%) in the PRP group were successful with the their VAS scores compared with the initial values, whereas DASH score, which was also significant (P 5 .005).
No fevers or rashes were reported. Apart from the local improvement (65.8 to 42.9; P 5 .818) (Figure 2). After 8 inflammation causing increased pain 3 to 4 weeks after the weeks, DASH scores improved 29.7% (161.3 to 113.4) in injection, no systemic or other local reactions were seen.
PRP patients versus a 35.5% improvement (131.26 to 84.7) The effect can be characterized as a local mechanism, in corticosteroid-treated patients (P 5 .999) (Figure 3).
without systemic side effects.
Twelve weeks after the procedure, PRP-treated patients If we set the criteria for success at 50% or 75% improve- reported a mean improvement of 44.8% (70.1 to 38.7) in their ment of both scores (instead of 25% improvement), the VAS scores compared with the initial values, whereas the results still show significant differences between both corticosteroid-treated patients reported a 32.8% improve- groups, as shown in Tables 3 and 4.
ment (65.8 to 44.2; P 5 .206) (Figure 2). Also, after 12 weeks, Regarding the cost, PRP is not cost-effective when com- DASH scores had improved 43.0% (161.3 to 92.0) in PRP pared with corticosteroid on a short-term basis. A PRP patients versus a 29.8% improvement (131.3 to 92.2) in treatment costs around e200 (current US$300, as of corticosteroid-treated patients (P 5 .060) (Figure 3).
2009). The DBC price for injection treatment Vol. 38, No. 2, 2010 Platelet-rich Plasma Versus Corticosteroid Injection FU (months)
Figure 3. Twenty-five of the 49 patients (51%) in the cortico- steroid (CS) group and 37 of the 51 patients (73%) patients inthe platelet-rich plasma (PRP) group were defined as suc- Figure 2. Twenty-four of the 49 patients (49%) in the cortico- cessful with the DASH Outcome Measure, a significant differ- steroid (CS) group and 37 of the 51 patients (73%) in the ence (P 5 .005). CI, confidence interval. 0, CS; x, PRP.
platelet-rich plasma (PRP) group were defined as successfulwith the visual analog score (VAS), a significant difference(P .001). CI, confidence interval. 0, CS; x, PRP.
epicondylitis; its application proved to be both safe andeasy. The corticosteroid group was actually better initially is e360 (US$540; DBC stands for Diagnose Behandeling and then declined, whereas the PRP group progressively Combinatie, or Diagnosis Treatment Combination). A improved. There was a significant difference in decrease DBC is an administrative code that combines diagnosis, of pain and disability of function following the platelet treatment, and all the related costs; a DBC therefore application after 26 weeks and 1 year.
includes all treatments per diagnosis, from the first visit Lateral epicondylitis is a common problem with many to the last checkup. So the overall cost for a PRP injection available treatment methods. The most commonly recom- will be around e560 (US$840) compared with the cortico- mended treatment is physiotherapy and bracing. Approxi- steroid injection of around e200 (US$300). But this does mately 87% of the patients benefit from this combination of not include all socioeconomic costs.
treatment methods.20 Now controversial, corticosteroid injection was once con- sidered the gold standard in the treatment of lateral epi- condylitis. However, studies show that it is merely thebest treatment option in the short-term, when compared This randomized study was designed to test the use of con- with physiotherapy and wait-and-see policy. Poor results centrated autologous platelets in patients with lateral seen after the 12-week follow-up.18 Treatment with The American Journal of Sports Medicine Pain Resolution for the Corticosteroid (CS) and Platelet-Rich Plasma (PRP) Groups Percentage Pain Reduction (%) Disability Resolution for the Corticosteroid (CS) and Platelet-Rich Plasma (PRP) Groups Disability Reduction Percentage Disability Reduction (%) corticosteroids has a high frequency of relapse and recur- System, the patient's own platelets can be collected into rence, probably because intratendinous injection may a highly concentrated formula. No activation agent was lead to permanent adverse changes within the structure used during our procedure. The activation of the platelets of the tendon and because patients tend to overuse the will occur through the exposure of platelets to the throm- arm after injection as a result of direct pain relief.18 bine, which is released from the tendon tissue during the In a meta-analysis, Smidt and colleagues17 showed that the effects of steroid injections—as compared with placebo During the first 2 days of tendon healing, an inflamma- injection, injection with local anesthetics, injection with tory process is initiated by migration of neutrophils and, another steroid, or another conservative treatment—are subsequently, macrophages to the degenerative tissue not significantly different in the intermediate and long- site. In turn, activated macrophages release multiple term. However, the patients who were examined all had growth factors, including platelet-derived growth factor, short-term lateral epicondylitis.
transforming growth factors alpha and beta, interleukin- There are various types of surgical procedures for 1, and fibroblast growth factor.4 Angiogenesis and fibropla- patients with chronic lateral epicondylitis. Verhaar and sia start shortly after day 3, followed by collagen synthesis colleagues noted an improvement in 60% to 70% of the on days 3 to 5. This process leads to an early increase in patients after surgical treatment, although higher success tendon breaking strength, which is the most important rates (80% to 90%) have more recently been reported.21,23 tendon healing parameter, followed by epithelization and, Patients remain, however, interested in an alternative to ultimately, the remodeling process. This was confirmed in an animal study.1 Platelet-rich plasma is promoted as an ideal autologous The treatment of tendinosis with an injection of concen- biological blood-derived product that can be exogenously trated autologous platelets may be a nonoperative alterna- applied to various tissues where, after being activated, it tive. Injection of autologous platelets has been shown to releases high concentrations of platelet-derived growth fac- improve repair in tendinosis in several animal and in vitro tors that enhance tissue healing.5,26 With the Recover 9,15 A possible explanation for the long-lasting Vol. 38, No. 2, 2010 Platelet-rich Plasma Versus Corticosteroid Injection effect of platelets could be that platelets improve the early submit the work for publication. J.A.P. Hagenaars did neotendon properties so that the cells are able to perceive the statistical analysis. He was an independent biostatisti- and respond to mechanical loading at an early time point.1 cian from the Tilburg University, The Netherlands. He did The results of the present study confirm the suggested not receive any funding for the statistical analysis. All positive effect in vivo as described by Mishra and authors declare that they participated in the writing of Pavelko.10 They reported a significant improvement of the article and that they saw and approved the final ver- symptoms after 8 weeks in 60% of the patients treated sion. Taco Gosens declares that he had full access to all with PRP versus 16% of the patients treated with a local the data in the study and takes responsibility for the integ- anesthetic. After 6 months the improvement in patients rity of the data and the accuracy of the data analysis. This treated with PRP was 81%. They compared PRP with trial was registered with ClinicalTrials.gov (identifier: a local anesthetic, which is not an accepted treatment for lateral epicondylitis in the Netherlands. Furthermore,they injected only 15 patients with PRP and comparedthem with 5 patients treated with a local anesthetic. The study was underpowered and the patients were notrandomized.
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