Objectives: This study tested the hypothesis that in treatment of rotator cuff (RC) injury, radial extracorporeal shock wave therapy (rESWT) is more effective than a combination of physical therapy modalities (PTMs; i.e., interferential current therapy, shortwave diathermy and magnetothermal therapy). Methods: A total of 60 patients with RC injury without presence of full-thickness RC tear were randomly allocated to rESWT for 6 weeks (n=30; one session per week) or treatment with PTMs for 6 weeks (n=30; five sessions per week). The primary outcome measure was the ASES shoulder score. Secondary outcome measures were the VAS pain score, patient's satisfaction, shoulder range of motion, thickness of the supraspinatus tendon and the acromiohumeral distance. All outcome measures were assessed by blinded assessors at baseline as well as at 6 weeks post-baseline (W6) and W12. Results: No serious adverse events occurred during the trial. Compared to the patients in the PTMs group, the patients in the rESWT group had significantly (p<0.05) higher mean ASES total scores at W6 and W12 (power with two-sided 95% confidence interval: 65.7% at W6 and 92.8% at W12) as well as lower mean VAS pain scores, higher mean satisfaction scores and higher mean active and passive shoulder abduction values at W6 and W12. Furthermore, rESWT but not PTMs significantly reduced the mean thickness of the ST and increased the acromiohumeral distance. Conclusion: In treatment of rotator cuff injury without presence of full-thickness rotator cuff tear, rESWT is more effective than the investigated combination of PTMs.

Christoph Schmitz served until 12/2017 and serves since 07/2024 as consultant for Electro Medical Systems (Nyon, Switzerland), the inventor, manufacturer and distributor of the rESWT device Swiss DolorClast that was used in this study. However, Electro Medical Systems did not have any role in data collection and analysis, interpretation of the data, decision to publish and writing the manuscript. The other authors declare no conflict of interest.

ChiCTR2300077386

This study was supported by Shanghai's Sixth People's Hospital (project number: ynhg202320). The sponsor of the study did not have any influence on data collection, analysis or publication. No constraints were placed on publication of the data.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of the Shanghai Sixth Peoples Hospital affiliated to Shanghai Jiao Tong University School of Medicine gave ethical approval for this work (No. 2023-132-(1)).

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The datasets used and analyzed during this trial are available from the corresponding author on reasonable request, taking into account any confidentiality.