Raffaello Pellegrino1,2, Fabrizio Brindisino3, Giovanni Barassi1, Eleonora Sparvieri4, Angelo DI Iorio5, Alessandro de Sire6, Carlo Ruosi7. 1. Unit of Antalgic Mini-Invasive and Rehab-Outpatients, Department of Medicine and Science of Aging, G. D'Annunzio University, Chieti, Italy. 2. Department of Scientific Research, Campus Ludes, Semmelweis University, Lugano, Switzerland. 3. Vincenzo Tiberio Department of Medicine and Health Science, Cardarelli Hospital, University of Molise, Campobasso, Italy. 4. Department of Internal Medicine, ASL Teramo, Teramo, Italy. 5. Unit of Antalgic Mini-Invasive and Rehab-Outpatients, Department of Medicine and Science of Aging, G. D'Annunzio University, Chieti, Italy - angelo.diiorio@unich.it. 6. Department of Medical and Surgical Sciences, Magna Græcia University of Catanzaro, Catanzaro, Italy. 7. School of Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Abstract
BACKGROUND: Rotator cuff tendinopathy (RCTe) is the most common cause of pain and shoulder dysfunction. Numerous clinical studies have demonstrated the therapeutic capacity of exogenous peritendinous hyaluronic acid (HA), and the effectiveness of extracorporeal shockwaves therapy (ESWT) in reducing pain. The aim of this study was to evaluate the added effects of HA treatment plus ESWT (E-g) or ESWT alone (SC-g), focusing on reduction of self-reported pain and disability of patients with RCTe. METHODS: Monocentric, randomized open-label clinical trial. Patients' selection, enrollment and interventions were conducted at the Chiparo Physical Medicine and Rehabilitation outpatient facility (Lecce, Italy). Patients with a diagnosis of RCTe, were randomly allocated to the E-g or to the SC-g. Participants were assessed for self-perceived pain, and for disability, at baseline, after 30 and 60 days. RESULTS: Forty adults (mean age 50.8±6.3; 23 woman, 17 men) were enrolled in the study, twenty for each group. During the study, both groups improved their perceived level of disability of the arm (-25.01±2.79; P<0.001), and for pain (-3.13±0.50; P<0.001). A multiplicative effect was demonstrated in the time × treatment interaction for disability (beta±SE beta: 7.40±1.77; P<0.001), and pain (beta±SE beta: 0.95±0.32; P<0.001). Moreover, more patients in the E-g reached the MCID in the outcomes-score compared to SC-g. Lastly, number needed to treat were calculated, for disability: NNT=2 (95% CI: 1-3), and for pain-score: NNT=1 (95% CI: 1-2). CONCLUSIONS: This study provides preliminary evidence that, compared to ESWT alone, the combining ESWT and peritendinous HA-injections, revert disability and reduces shoulder pain faster in patients with RCTe.
BACKGROUND: Rotator cuff tendinopathy (RCTe) is the most common cause of pain and shoulder dysfunction. Numerous clinical studies have demonstrated the therapeutic capacity of exogenous peritendinous hyaluronic acid (HA), and the effectiveness of extracorporeal shockwaves therapy (ESWT) in reducing pain. The aim of this study was to evaluate the added effects of HA treatment plus ESWT (E-g) or ESWT alone (SC-g), focusing on reduction of self-reported pain and disability of patients with RCTe. METHODS: Monocentric, randomized open-label clinical trial. Patients' selection, enrollment and interventions were conducted at the Chiparo Physical Medicine and Rehabilitation outpatient facility (Lecce, Italy). Patients with a diagnosis of RCTe, were randomly allocated to the E-g or to the SC-g. Participants were assessed for self-perceived pain, and for disability, at baseline, after 30 and 60 days. RESULTS: Forty adults (mean age 50.8±6.3; 23 woman, 17 men) were enrolled in the study, twenty for each group. During the study, both groups improved their perceived level of disability of the arm (-25.01±2.79; P<0.001), and for pain (-3.13±0.50; P<0.001). A multiplicative effect was demonstrated in the time × treatment interaction for disability (beta±SE beta: 7.40±1.77; P<0.001), and pain (beta±SE beta: 0.95±0.32; P<0.001). Moreover, more patients in the E-g reached the MCID in the outcomes-score compared to SC-g. Lastly, number needed to treat were calculated, for disability: NNT=2 (95% CI: 1-3), and for pain-score: NNT=1 (95% CI: 1-2). CONCLUSIONS: This study provides preliminary evidence that, compared to ESWT alone, the combining ESWT and peritendinous HA-injections, revert disability and reduces shoulder pain faster in patients with RCTe.