CONTEXT: Extracorporeal shock wave therapy (ESWT) has been used to treat calcific tendonitis of the shoulder, but trials of ESWT for this purpose have had methodological deficiencies and thus there is limited evidence for its effectiveness. OBJECTIVE: To determine whether fluoroscopy-guided ESWT improves function, reduces pain, and diminishes the size of calcific deposits in patients with chronic calcific tendonitis of the shoulder. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, placebo-controlled trial conducted between February 1997 and March 2001 among 144 patients (of 164 screened) recruited from referring primary care physicians, orthopedic surgeons, and sports physicians in 7 orthopedic departments in Germany and Austria. INTERVENTIONS: Either high-energy ESWT, low-energy ESWT, or placebo (sham treatment). The 2 ESWT groups received the same cumulative energy dose. Patients in all 3 groups received 2 treatment sessions approximately 2 weeks apart, followed by physical therapy. MAIN OUTCOME MEASURES: The primary end point was the change in the mean Constant and Murley Scale (CMS) score from baseline to 6 months after the intervention. Secondary end points were changes in the mean CMS scores at 3 and 12 months, as well as changes in self-rated pain and radiographic change in size of calcific deposits at 3, 6, and 12 months. RESULTS: Of 144 patients enrolled, all completed treatment as randomized and 134 completed the 6-month follow-up. Both high-energy and low-energy ESWT resulted in significant improvement in the 6-month mean (95% confidence interval [CI]) CMS score compared with sham treatment (high-energy ESWT: 31.0 [26.7-35.3] points; low-energy ESWT: 15.0 [10.2-19.8] points; sham treatment: 6.6 [1.4-11.8] points; P<.001 for both comparisons). Patients who received high-energy ESWT also had significant 6-month CMS improvements compared with those who received low-energy ESWT (P<.001). We found similar results for both the 3-month and 12-month CMS comparisons, as well as for self-rated pain and radiographic changes at 3, 6, and 12 months. CONCLUSIONS: Both high-energy and low-energy ESWT appeared to provide a beneficial effect on shoulder function, as well as on self-rated pain and diminished size of calcifications, compared with placebo. Furthermore, high-energy ESWT appeared to be superior to low-energy ESWT.
RCT Entities:
CONTEXT: Extracorporeal shock wave therapy (ESWT) has been used to treat calcific tendonitis of the shoulder, but trials of ESWT for this purpose have had methodological deficiencies and thus there is limited evidence for its effectiveness. OBJECTIVE: To determine whether fluoroscopy-guided ESWT improves function, reduces pain, and diminishes the size of calcific deposits in patients with chronic calcific tendonitis of the shoulder. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, placebo-controlled trial conducted between February 1997 and March 2001 among 144 patients (of 164 screened) recruited from referring primary care physicians, orthopedic surgeons, and sports physicians in 7 orthopedic departments in Germany and Austria. INTERVENTIONS: Either high-energy ESWT, low-energy ESWT, or placebo (sham treatment). The 2 ESWT groups received the same cumulative energy dose. Patients in all 3 groups received 2 treatment sessions approximately 2 weeks apart, followed by physical therapy. MAIN OUTCOME MEASURES: The primary end point was the change in the mean Constant and Murley Scale (CMS) score from baseline to 6 months after the intervention. Secondary end points were changes in the mean CMS scores at 3 and 12 months, as well as changes in self-rated pain and radiographic change in size of calcific deposits at 3, 6, and 12 months. RESULTS: Of 144 patients enrolled, all completed treatment as randomized and 134 completed the 6-month follow-up. Both high-energy and low-energy ESWT resulted in significant improvement in the 6-month mean (95% confidence interval [CI]) CMS score compared with sham treatment (high-energy ESWT: 31.0 [26.7-35.3] points; low-energy ESWT: 15.0 [10.2-19.8] points; sham treatment: 6.6 [1.4-11.8] points; P<.001 for both comparisons). Patients who received high-energy ESWT also had significant 6-month CMS improvements compared with those who received low-energy ESWT (P<.001). We found similar results for both the 3-month and 12-month CMS comparisons, as well as for self-rated pain and radiographic changes at 3, 6, and 12 months. CONCLUSIONS: Both high-energy and low-energy ESWT appeared to provide a beneficial effect on shoulder function, as well as on self-rated pain and diminished size of calcifications, compared with placebo. Furthermore, high-energy ESWT appeared to be superior to low-energy ESWT.