Radial extracorporeal shock wave therapy for adhesive capsulitis of the shoulder: A prospective, randomized, placebo controlled, double-blind study with subjective and objective endpoints

Abstract

This study tested the hypothesis that radial extracorporeal shock wave therapy (rESWT) is effective and safe in the treatment of adhesive capsulitis of the shoulder (adC-S). One hundred and six patients (mean age, 55.8 years; range, 39–77) with pain and limitations in shoulder mobility due to adC-S lasting for averaged 11.6 months (range, 9–14) were randomly allocated to either rESWT ( n = 53) (four sessions, one session per week, Swiss DolorClast [Electro Medical Systems S.A., Nyon, Switzerland], radial handpiece, 15-mm applicator, 2000 rESWT impulses per session, positive energy flux density 0.14 mJ/mm 2 , rESWT impulses applied at 8 Hz) or placebo treatment ( n = 53). Patients completed the Visual Analog Scale (VAS) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at baseline (BL) as well as at one month (M1), six months (M6) and twelve months (M12) after baseline. Moreover, passive and active abduction of the arm (pA and aA) as well as passive external rotation of the shoulder (pER) were measured at BL, M1, M6 and M12. All patients completed the final review at M12 and were included in the study. Mean pretreatment VAS scores, DASH scores and pA, aA and pER measurements for the rESWT and control groups were 6.3 and 6.3 (VAS), 73.5 and 72.5 (DASH), 98.2 and 99.3 degrees (pA), 65.8 and 68.8 degrees (aA), and 20.3 and 22.0 degrees (pER), respectively. Compared to placebo treatment rESWT resulted in statistically significantly reduced VAS score (by averaged 3.5 points) and statistically significantly improved DASH score (53.8 points), pA (63.9 degrees), aA (79.1 degrees) and pER (43.3 degrees) at all follow-up examinations. rESWT as performed in the present study is an effective and safe treatment for adhesive capsulitis of the shoulder.