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Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels |
Ioppolo F, Tattoli M, di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V |
Physical Therapy 2012 Nov;92(11):1376-1385 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Extracorporeal shock-wave therapy (ESWT) represents a valid instrument in the treatment of supraspinatus calcifying tendonitis (SCT) but there is limited evidence for the useful range of ESWT doses in its management. OBJECTIVE: To compare two different ranges of energy flux density in treatment of SCT with ESWT. DESIGN: This study was designed as a single-blind randomized clinical trial. SETTING: This study was performed in a university hospital. PATIENTS: Forty-six patients with SCT were randomly assigned to two different therapeutic energy doses of ESWT. INTERVENTION: Treatment protocol consisted of 4 sessions performed once a week for 4 weeks with an energy level of 0.20 mJ/mm2 in group A and 0.10mJ/mm2 in group B. MEASUREMENTS: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. The change in the mean visual analogic scale scores from baseline to 3 and 6 months after the intervention and radiographic change in size of calcium deposits were evaluated as secondary end points. At 12 months pain relief was assessed using the numerical rating scale. RESULTS: We observed significant clinical improvement after 6 months of CMS score mean in group A (79.43 (10.33)), compared to group B (57.91 (6.53)). Likewise, after 6 months we found a significant VAS scores decrease in group A (2.09 (1.54)) with respect to group B (5.36 (0.78)). Calcific deposits disappeared in the same percentage of patients in both groups. LIMITATIONS: Sample size and lack of a control group. CONCLUSIONS: In ESWT for SCT, an energy level of 0.20 mJ/mm2 appears to be more effective than an energy level of 0.10 mJ/mm2 in pain relief and functional improvement.
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