Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels

Abstract

Background: Extracorporeal shock-wave therapy (ESWT) represents a valid intervention in the treatment of people with supraspinatus calcifying tendinitis (SCT), but there is limited evidence for the useful range of ESWT doses.

Objective: The aim of this study was to compare 2 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 2 groups that received different therapeutic energy doses of ESWT: (1) group A received ESWT at an energy level of 0.20 mJ/mm², and (2) group B received ESWT at an energy level of 0.10 mJ/mm².

Intervention: The treatment protocol consisted of 4 sessions performed once a week.

Measurements: The change in mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. The change in the mean visual analog scale (VAS) scores from baseline to 3 and 6 months after the intervention and radiographic change in size of calcium deposits were evaluated as secondary endpoints. At 12 months, pain relief was assessed using a numeric rating scale.

Results: Significant clinical improvement based on mean CMS scores was observed after 6 months in group A (X=79.43, SD=10.33) compared with group B (X=57.91, SD=6.53). Likewise, after 6 months, a significant decrease in VAS scores was found in group A (X=2.09, SD=1.54) compared with group B (X=5.36, SD=0.78). Calcific deposits disappeared in the same percentage of patients in both groups.

Limitations: The small sample size and lack of a control group were limitations of the study.

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.

Trial registration: ClinicalTrials.gov NCT01602653.