High-frequency Short-course Extracorporeal Shock Wave Therapy for Partial Rotator Cuff Tears: Study Protocol for a Multicenter, Randomized, Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

This trial has no locations