High-frequency Short-course Extracorporeal Shock Wave Therapy for Partial Rotator Cuff Tears: Study Protocol for a Multicenter, Randomized, Controlled Trial
NCT07673055 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-06-29
Summary
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.
Conditions
- Partial Rotator Cuff Tears (PRCTs)
Interventions
- DEVICE
-
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
Arm 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)
Sponsors & Collaborators
-
Peking University Third Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2027-01-01
- Primary Completion
- 2027-12-01
- Completion
- 2030-01-01
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