Bernard Montalvan1, Patrick Le Goux2, Shahnaz Klouche3, Delphine Borgel4, Philippe Hardy5, Maxime Breban6. 1. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de rhumatologie, Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de Chirurgie Orthopédique et Traumatologique, bernard.montalvan2@libertysurf.fr. 2. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de rhumatologie, Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de Chirurgie Orthopédique et Traumatologique. 3. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de Chirurgie Orthopédique et Traumatologique. 4. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service d'Hématologie et d'Immunologie, F-92100 Boulogne-Billancourt. 5. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de Chirurgie Orthopédique et Traumatologique, Université de Versailles Saint-Quentin-en-Yvelines, UFR des Sciences de la Santé, Versailles and. 6. Hôpitaux Universitaires Paris Ile de France Ouest, AP-HP, Service de rhumatologie, Université de Versailles Saint-Quentin-en-Yvelines, INSERM U1173, UFR Simone Veil, Laboratoire d'Excellence INFLAMEX, Montigny-le-Bretonneux, France.
Abstract
OBJECTIVES: The aim was to assess the efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤3 months). METHODS: Our study was a double-blind placebo-controlled randomized trial. Two US-guided injections of either PRP (autologous conditioned plasma) or saline solution were performed with an interval of 4 weeks. The exclusion criterion was previous CS infiltration. Patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months of follow-up. The primary evaluation criterion was the relative improvement from baseline to 6 months in pain score on visual analog scale (0-10). Secondary criteria were the Roles-Maudsley score and the assessment of pain on isometric contraction of extensor carpi radialis brevis and extensor digitorum communis. RESULTS:Twenty-five patients were randomly assigned to each group. Three patients in each arm dropped out before 6 months. In both groups, the pain score [mean (s.d.)] decreased significantly between two consecutive visits from 6.8 (0.8) (PRP) and 7 (1) (saline) at baseline to 2.5 (1.6) and 1.6 (1.5) (PRP) and to 2.1 (1.6) and 1.8 (2.1) (saline) at 6 and 12 months, respectively. At 6 months, no statistically significant difference was found between groups for relative improvement in pain score [autologous conditioned plasma: -63.2 (22.4%); saline: -69.7 (25.1%); P = 0.24]. No significant difference was found for the secondary criteria. CONCLUSION: Two US-guided PRP injections for epicondylitis of recent evolution were not more efficacious than saline injections, until 6- and 12-months follow-up. TRIAL REGISTRATION: ClinicalTrials.gov; https://clinicaltrials.gov/; NCT02378285.
RCT Entities:
OBJECTIVES: The aim was to assess the efficacy of two intra-tendinous injections of platelet-rich plasma (PRP) on epicondylitis of recent evolution (≤3 months). METHODS: Our study was a double-blind placebo-controlled randomized trial. Two US-guided injections of either PRP (autologous conditioned plasma) or saline solution were performed with an interval of 4 weeks. The exclusion criterion was previous CS infiltration. Patients were monitored by an independent evaluator blinded to treatment at baseline and 1, 3, 6 and 12 months of follow-up. The primary evaluation criterion was the relative improvement from baseline to 6 months in pain score on visual analog scale (0-10). Secondary criteria were the Roles-Maudsley score and the assessment of pain on isometric contraction of extensor carpi radialis brevis and extensor digitorum communis. RESULTS: Twenty-five patients were randomly assigned to each group. Three patients in each arm dropped out before 6 months. In both groups, the pain score [mean (s.d.)] decreased significantly between two consecutive visits from 6.8 (0.8) (PRP) and 7 (1) (saline) at baseline to 2.5 (1.6) and 1.6 (1.5) (PRP) and to 2.1 (1.6) and 1.8 (2.1) (saline) at 6 and 12 months, respectively. At 6 months, no statistically significant difference was found between groups for relative improvement in pain score [autologous conditioned plasma: -63.2 (22.4%); saline: -69.7 (25.1%); P = 0.24]. No significant difference was found for the secondary criteria. CONCLUSION: Two US-guided PRP injections for epicondylitis of recent evolution were not more efficacious than saline injections, until 6- and 12-months follow-up. TRIAL REGISTRATION: ClinicalTrials.gov; https://clinicaltrials.gov/; NCT02378285.
Authors: Jenny F López; Jertta-Riina Sarkanen; Outi Huttala; Ilkka S Kaartinen; Hannu O Kuokkanen; Timo Ylikomi Journal: Cytotechnology Date: 2018-03-06 Impact factor: 2.058
Authors: Luca Maria Sconfienza; Miraude Adriaensen; Domenico Albano; Maria Pilar Aparisi Gómez; Alberto Bazzocchi; Ian Beggs; Bianca Bignotti; Vito Chianca; Angelo Corazza; Danoob Dalili; Miriam De Dea; Jose Luis Del Cura; Francesco Di Pietto; Eleni Drakonaki; Fernando Facal de Castro; Dimitrios Filippiadis; Jan Gielen; Salvatore Gitto; Harun Gupta; Andrea S Klauser; Radhesh Lalam; Silvia Martin; Carlo Martinoli; Giovanni Mauri; Catherine McCarthy; Eugene McNally; Kalliopi Melaki; Carmelo Messina; Rebeca Mirón Mombiela; Benedikt Neubauer; Marina Obradov; Cyprian Olchowy; Davide Orlandi; Athena Plagou; Raquel Prada Gonzalez; Saulius Rutkauskas; Ziga Snoj; Alberto Stefano Tagliafico; Alexander Talaska; Violeta Vasilevska-Nikodinovska; Jelena Vucetic; David Wilson; Federico Zaottini; Marcello Zappia; Georgina Allen Journal: Eur Radiol Date: 2019-12-16 Impact factor: 5.315