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Sportverletz Sportschaden 2017; 31(01): 31-36
DOI: 10.1055/s-0043-101042
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Autologous Conditioned Plasma Versus Placebo Injection Therapy in Lateral Epicondylitis of the Elbow: A Double Blind, Randomized Study

Autologes konditioniertes Plasma versus Placebo in der Therapie der lateralen Epikondylitis – eine randomisierte Doppelblindstudie
Volker Schöffl
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
2   Department of Trauma Surgery, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, FRG
3   Department of Emergency Medicine, University of Colorado Medical School, Denver, USA
,
Wolfgang Willauschus
4   Alpha Med, Bamberg, FRG
,
Felix Sauer
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
,
Thomas Küpper
5   Institute of Occupational and Social Medicine, RWTH Aachen Technical University, Aachen, FRG
,
Isabelle Schöffl
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
6   Department of Pediatrics, Klinikum Bamberg, FRG
,
Christoph Lutter
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
7   CVPath Institute, Gaithersburg, USA
,
Kolja Gelse
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
,
Jörg Dickschas
1   Department of Orthopedic and Trauma Surgery, Sportsorthopedics and Sportsmedicine, Klinikum Bamberg, Bamberg, FRG
2   Department of Trauma Surgery, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, FRG
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2017 (online)

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Abstract

Introduction There are various therapeutic approaches to the treatment of lateral epicondylitis, a highly prevalent musculoskeletal disorder. Recently, injection therapy with autologous conditioned plasma (ACP) has shown promise as a new approach.

Methods Set up as a prospective, double-blind, randomized controlled clinical trial, this study involved 50 patients with lateral epicondylitis. Following external randomization, 25 patients received one round of injection therapy with ACP (platelet rich plasma, PRP), while the remaining 25 patients received a placebo of 0.9 % NaCl. All patients were re-evaluated with respect to lateral epicondylitis of the elbow at four-weeks and six-months post-injection.

Results Out of 50 patients, 36 qualified for reevaluation, 18 patients from the ACP therapy group and 18 from the placebo group. The initial Disability of the Arm, Shoulder and Hand (DASH) score for all reevaluated patients was 36.4 in the ACP group, and 41.0 in the placebo group; both groups exhibited decreased DASH scores at the four-week and six-month post-injection follow-up (6 months: ACP 30.1, placebo 25.8). The decrease of the DASH score after 4 weeks was greater and qualified as statistically significant in the placebo group (p = 0.041), compared to the DASH score decrease in the ACP treatment group, which was statistically non-significant. Additionally, the difference between the DASH scores of the treatment and placebo groups was statistically non-significant four weeks and six months after treatment.

Discussion The results of this study suggest a therapeutic effect in both the ACP and placebo groups, with no evidence for a therapeutically significant difference between ACP and placebo treatments. It is hypothesized that, in accordance with the study protocols, injection with a local anaesthetic prior to ACP therapy may have an influence on the therapeutic effect of ACP. Future studies have to confirm recent findings that demonstrated a minimizing, or even inhibiting, action of local anaesthetics on the effects of ACP/PRP.

Conclusion The effect of ACP/PRP injections needs to be investigated in future studies under standardized conditions.

Zusammenfassung

Einführung Die Epicondylitis radialis humeri am Ellenbogen ist ein weit verbreitetes und oft langwieriges Krankheitsbild. Die konservativen Behandlungsmethoden umfassen orale NSAR-Gabe, Bandagen-Verordnungen, Salbenapplikationen, Physiotherapie, Stoßwellentherapie und weitere Methoden. Als ultima ratio werden operative Verfahren, z. B. nach Wilhelm-Hohmann oder Nirschl durchgeführt. Eine neue Behandlungsmethode ist die Applikation von autologen konditioniertem Plasma (ACP). Validierte Studienergebnisse über diese Behandlung am Ellenbogen liegen bisher aber nur eingeschränkt vor.

Material und Methoden 50 Patienten mit klinisch relevanter Epicondylitis radialis humeri werden in einer prospektiven, randomisierten Doppelblind-Studie untersucht. Im ersten Studienarm werden 25 Patienten mit ACP behandelt, im Vergleichsarm 25 Patienten mit NaCl-Lösung (Placebo). 3 Behandlungen mit 5 – 7 Tagen behandlungsfreien Intervall dazwischen werden durchgeführt, die Folgebehandlungen ohne Bupivacain. Bei den 25 Kontrollgruppen – Patienten wird nach gleicher Vorbereitung das Plasma verworfen und NaCl infiltriert (Placebo). Die Injektion erfolgte jeweils in abgeklebten Spritzen (Doppelblind). Die Nachuntersuchung erfolgte nach 6 Monaten, es wurde jeweils der DASH-Score erhoben.

Ergebnisse Von 50 inkludierten Patienten (28 Männer, 22 Frauen; Durchschnittsalter 52,6 Jahre; linker Arm 23, rechter Arm 27) konnten 36 Patienten in der Nachsorgeuntersuchung eingeschlossen werden. Der DASH-Score lag bei der ACP-Gruppe vor Anwendung bei 41,2 Punkten, bei der Placebo-Gruppe bei 39,1 Punkten (Unterschied nicht signifikant). Beide Gruppen zeigten nach 6 Monaten einen verbesserten DASH-Score (ACP-Gruppe 30,1; Placebo-Gruppe 25,8), im T-Test gibt es keine Mittelwertunterschiede zwischen beiden Gruppen. Die Besserung in der ACP-Gruppe ist nicht signifikant (p > 0,05), die Besserung in der Placebo-Gruppe ist signifikant (p 0.027). Es gibt keinen signifikanten Unterschied zwischen männlich und weiblich. Auch die Seite hat keinen signifikanten Einfluss.

Diskussion Die Behandlung der Epicondylitis lateralis am Ellenbogen zeigt sowohl mit ACP-Injektionen als auch mit NaCl-Injektionen nach 6 Monaten eine Besserung im DASH-Score. Die Besserung ist bei der Placebo-Injektion signifikant, bei der ACP-Injektion nicht. Eine nach Studienbeginn veröffentlichte Arbeit hat gezeigt, dass Bupivacain den proliferationsfördernden Effekt von ACP nahezu vollständig inhibiert, was eine mögliche Erklärung für das Abschneiden von ACP bei dieser Studie ist.

Schlussfolgerung Weitere Untersuchungen zur Evidenz der ACP und vor allem zu einem möglichen inhibierenden Effekt einer zusätzlichen Gabe von Lokalanästhetika sind nötig.

Key words

ACP - PRP - platelet-rich plasma - autologous conditioned plasma - epicondylitis tennis elbow

Schlüsselwörter

ACP - PRP - autologes konditioniertes Plasma - Epikondylitis - Tennisellbogen
 

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