High-frequency Short-course Extracorporeal Shock Wave Therapy for Partial Rotator Cuff Tears: Study Protocol for a Multicenter, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Change in 100-mm Visual Analog Scale (VAS) score for shoulder pain
研究概览
简要总结
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.
详细描述
- Study Background Partial rotator cuff tears are extremely prevalent musculoskeletal disorders, affecting 20-30% of the general population and over 40% of people aged 60 and above. The condition causes persistent shoulder pain, night pain and restricted shoulder movement, interfering with daily activities and quality of life. International clinical guidelines recommend conservative treatment as the first choice for this disease to avoid surgical risks such as infection and tissue adhesion.
Extracorporeal shock wave therapy (ESWT) is a widely used non-invasive physical therapy for tendon injuries. It promotes blood circulation, tendon repair and pain relief. However, the conventional low-frequency ESWT plan (one session per week for 7 weeks) has obvious drawbacks: slow symptom relief, long treatment cycle and poor patient adherence. Early single-center research has confirmed that a daily high-frequency short-course ESWT works better for pain control, functional recovery and tendon healing, with good safety. This formal multicenter trial is designed to verify these findings and further optimize treatment protocols. 2. Study Objectives Primary goal: Compare the efficacy of two high-frequency ESWT regimens and the conventional regimen in reducing shoulder pain of patients with partial rotator cuff tears at 3 months after treatment.
Secondary goals: Evaluate the improvements of shoulder joint function and range of motion; use MRI and ultrasound to objectively assess tendon repair status; analyze patient treatment compliance and incidence of adverse reactions; develop an optimized, evidence-based ESWT standard protocol for clinical promotion. 3. Study Design & Participants Study Design This is a prospective, multicenter, three-arm parallel-group randomized controlled trial with outcome assessor blinding. Participants will be randomly divided into three groups at a 1:1:1 ratio. All treatment groups adopt identical ESWT technical parameters: 2000 shocks per session, 10 Hz frequency, energy flux density of 0.1-0.25 mJ/mm².
Three Treatment Groups Group 1 (High-frequency short-course group): Receive ESWT once a day for 7 consecutive days (7 sessions in total within 1 week).
Group 2 (High-frequency intensive group): Complete 3 treatment cycles. Each cycle includes 7 consecutive daily ESWT sessions, with a 1-week rest between cycles (21 sessions in total within 7 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Concurrent shoulder pathologies including glenohumeral osteoarthritis, adhesive capsulitis (frozen shoulder), or shoulder instability
- •Systemic diseases (e.g., rheumatoid arthritis), bleeding disorders, or coagulopathy
- •Pregnancy or lactation
- •Contraindications to ESWT (e.g., cardiac pacemaker, malignancy at treatment site)
- •Inability to complete treatment or follow-up schedule
研究组 & 干预措施
High-frequency short-course extracorporeal shock wave therapy (ESWT)
Participants receive daily ESWT for 7 consecutive days (7 total sessions within 1 week). Standard treatment parameters for each session: 2000 shocks, 10 Hz frequency, energy flux density of 0.1-0.25 mJ/mm² (adjusted gradually per patient tolerance). The treatment site is the most tender area over the rotator cuff, confirmed by palpation and ultrasound guidance. All participants also receive standardized activity modification guidance and home rehabilitation exercises. Oral non-steroidal anti-inflammatory drugs (NSAIDs) are permitted and recorded; other physical therapies are prohibited during active treatment.
干预措施: 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 (Device)
High-frequency intensive ESWT
Participants complete 3 cycles of ESWT. Each cycle consists of 7 consecutive daily ESWT sessions, with a 1-week rest interval between cycles (21 total sessions over 7 weeks). Identical ESWT parameters are used for every session: 2000 shocks, 10 Hz frequency, energy flux density of 0.1-0.25 mJ/mm² (adjusted per patient tolerance), targeting the tender rotator cuff area confirmed by ultrasound. All participants receive unified activity advice and home rehabilitation exercises. Oral NSAIDs are allowed and documented; additional physical therapies are not permitted during treatment.
干预措施: 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 (Device)
Conventional ESWT (Active Comparator)
Participants receive ESWT once per week for 7 consecutive weeks (7 total sessions over 7 weeks). Each session uses the same standardized parameters as the other two arms: 2000 shocks, 10 Hz frequency, energy flux density of 0.1-0.25 mJ/mm², with the treatment location guided by palpation and ultrasound. All participants follow the same activity modification instructions and home exercise program. Oral NSAIDs are permitted (recorded), and other physical interventions are restricted during the active treatment period.
干预措施: 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 (Device)
结局指标
主要结局
Change in 100-mm Visual Analog Scale (VAS) score for shoulder pain
时间窗: Baseline (pre-treatment) and 3 months after completion of intervention
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.
次要结局
- American Shoulder and Elbow Surgeons (ASES) Score(Baseline, 3 months, 6 months, 12 months post-treatment)
- Constant-Murley Score (CMS)(Baseline, 3 months, 6 months, 12 months post-treatment)
- Shoulder Range of Motion (ROM)(Baseline, 3 months, 6 months, 12 months post-treatment)
- MRI Signal-to-Noise Ratio (SNR) of Rotator Cuff Tendon(Baseline, 6 months, 12 months post-treatment)