This is a multicenter, randomized controlled clinical study exploring three different extracorporeal shock wave therapy (ESWT) regimens for patients with partial rotator cuff tears, a common cause of chronic shoulder pain and limited movement. Traditional ESWT uses a once-weekly treatment schedule over 7 weeks, which takes a long time and leads to low patient compliance. This study aims to test two new high-frequency, short-course ESWT protocols, compare their pain relief, shoulder function improvement, tendon healing effect, safety and treatment adherence with the conventional regimen, and finally establish a more efficient, patient-friendly standardized treatment plan for clinical use. A total of 300 eligible participants will be recruited from 10 top-tier hospitals across China and followed up for 12 months after treatment.
Age 30-70 years, male or female
MRI- or high-resolution ultrasound-confirmed partial-thickness rotator cuff tear (predominantly supraspinatus) or small full-thickness tear without retraction or displacement
Shoulder pain duration ≥3 months with Visual Analog Scale (VAS) score ≥4 (0-10 scale)
Willing and able to provide written informed consent and comply with the study protocol
Large or massive full-thickness rotator cuff tear, tear with Grade II retraction or greater, or presence of a greater tuberosity bone cyst
Severe muscle fatty infiltration (Goutallier grade ≥3) on MRI
Uncontrolled diabetes mellitus (HbA1c >7.5%), hypothyroidism, or heavy smoking (≥20 pack-years)
Received local injection therapy (e.g., corticosteroids, platelet-rich plasma) to the affected shoulder within 4 weeks prior to enrollment
Parallel
Arm 1 Intervention Name: High-frequency short-course extracorporeal shock wave therapy Arm 2 Intervention Name: High-frequency intensive extracorporeal shock wave therapy Arm 3 Intervention Name: Conv
DeviceArm 1: 7 daily sessions, 1 total week (single short cycle) Arm 2: 3 cycles of 7 daily sessions + 1-week rest between cycles, 7 total weeks (intensive multi-cycle) Arm 3: 7 weekly sessions, 7 total weeks (traditional low-frequency)
Change in 100-mm Visual Analog Scale (VAS) score for shoulder pain
The primary outcome is the change in active shoulder abduction pain intensity measured via a 100-mm Visual Analog Scale (VAS; 0 = no pain, 100 = worst imaginable pain). Comparisons are made across three treatment groups from baseline to 3 months post-intervention.
American Shoulder and Elbow Surgeons (ASES) Score
Change in ASES shoulder functional score from baseline to 3, 6, and 12 months post-intervention. Higher scores indicate better shoulder function.
Constant-Murley Score (CMS)
Change in Constant-Murley shoulder function score from baseline to 3, 6, and 12 months post-intervention, to comprehensively evaluate overall shoulder performance.
Shoulder Range of Motion (ROM)
Changes in active and passive forward flexion, abduction, and external rotation of the shoulder measured by a standard goniometer at follow-up time points.
MRI Signal-to-Noise Ratio (SNR) of Rotator Cuff Tendon
Quantitative change in MRI signal-to-noise ratio of the torn rotator cuff tendon, reflecting tendon tissue repair status.
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