Partial Rotator Cuff Tears (PRCTs)NCT07673055
High-frequency Short-course Extracorporeal Shock Wave Therapy for Partial Rotator Cuff Tears: Study Protocol for a Multicenter, Randomized, Controlled Trial
A study testing 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 in people with Partial Rotator Cuff Tears (PRCTs), run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Rotator Cuff Tears (PRCTs)
- What is being tested?
- 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
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Contraindications to ESWT (e.g., cardiac pacemaker, malignancy at treatment site)
- Inability to complete treatment or follow-up schedule
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
- 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.
- 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.
- 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). Group 3 (Conventional group/control): Receive ESWT once a week for 7 consecutive weeks (7 sessions in total within 7 weeks). Eligibility Criteria Inclusion Criteria Aged 30 to 70 years, regardless of gender. Diagnosed with partial-thickness rotator cuff tear or small non-retracted full-thickness rotator cuff tear via MRI or high-resolution ultrasound. Shoulder pain lasting for at least 3 months, with a pain score (VAS) of 4 points or higher (0-10 scale). Voluntarily join the study and sign written informed consent, and agree to complete all treatments and follow-up visits. Exclusion Criteria Severe full-thickness rotator cuff tear, tendon retraction above Grade II, or greater tuberosity bone cyst. Severe muscle fatty infiltration of the shoulder (Goutallier grade ≥3) shown on MRI. Poorly controlled diabetes, hypothyroidism, or heavy long-term smoking. Received local injections (corticosteroids, platelet-rich plasma etc.) on the affected shoulder within the past 4 weeks. Combined with severe shoulder osteoarthritis, frozen shoulder, shoulder instability, rheumatoid arthritis, bleeding disorders or coagulation problems. Pregnant or breastfeeding women; patients with cardiac pacemakers or tumors at the treatment site (contraindications for ESWT). Unable to finish the full course of treatment or follow-up arrangements. Recruitment Scale \& Centers A maximum of 300 participants will be enrolled from 10 tertiary hospitals nationwide, including Peking University Third Hospital, Beijing Chao-Yang Hospital, West China Hospital of Sichuan University and other renowned medical institutions. The recruitment period lasts from January 2026 to December 2027.
- Combined Care \& Follow-up Arrangements All participants will receive unified guidance on daily activity adjustment and home rehabilitation exercises. Oral pain-relieving anti-inflammatory drugs are allowed and will be recorded, while other physical therapies (ultrasound, laser, massage etc.) are prohibited during treatment. Follow-up time points: Baseline (before treatment), 3 months, 6 months and 12 months after treatment. At each follow-up, researchers will assess pain degree, shoulder function and joint mobility. MRI and ultrasound re-examinations will be conducted at baseline, 6 months and 12 months to evaluate tendon healing. All adverse reactions during treatment and follow-up will be recorded in detail.
- Evaluation Indicators Primary indicator: Changes of shoulder pain score (VAS) from baseline to 3 months after intervention. Secondary indicators: Shoulder function scores (ASES, Constant-Murley Score) and active/passive joint range of motion. Imaging indicators: Changes of tendon signal-to-noise ratio, tear size and tendon thickness detected by MRI and ultrasound. Treatment adherence: The proportion of participants who complete the scheduled treatment sessions. Safety indicators: Types, quantity and severity of adverse events (local redness, swelling, skin petechiae, transient pain aggravation etc.). Patients' overall subjective evaluation of symptom improvement.
- Study Strengths \& Implementation Notes To avoid assessment bias, the staff responsible for evaluating curative effects and reading imaging images will not know which treatment group each participant belongs to. All operating procedures, assessment standards and imaging measurement methods are unified across all participating hospitals to ensure data accuracy and consistency. This study is the first multicenter trial comparing high-frequency short-course ESWT and conventional regimens for partial rotator cuff tears. It combines subjective symptom scores and objective imaging biomarkers to obtain reliable clinical evidence. After the trial ends, the research team will form a set of optimized ESWT application specifications, which will be promoted to clinical departments such as rehabilitation and sports medicine to provide a better non-surgical treatment option for patients with partial rotator cuff tears.
- Ethical Statement The study strictly follows the Declaration of Helsinki and clinical trial norms. The protocol has passed the ethical review of all participating hospitals. All participants have the right to withdraw from the study at any time without penalty. Personal medical information of all participants will be encrypted and kept confidential to protect privacy.
- Conditions
- Partial Rotator Cuff Tears (PRCTs)
- Being tested
- 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
- Keywords
- Partial rotator cuff tears, Extracorporeal shock wave therapy, High-frequency short-course therapy, Shoulder pain, Treatment adherence
- Medical subject headings
- Shoulder Pain, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: ConvDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| High-frequency short-course extracorporeal shock wave therapy (ESWT) | Experimental | 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. Receives: 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 |
| High-frequency intensive ESWT | Experimental | 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. Receives: 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 |
| Conventional ESWT (Active Comparator) | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-treatment) and 3 months after completion of intervention
Secondary outcomes (4)
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.
Measured: Baseline, 3 months, 6 months, 12 months post-treatment
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.
Measured: Baseline, 3 months, 6 months, 12 months post-treatment
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.
Measured: Baseline, 3 months, 6 months, 12 months post-treatment
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.
Measured: Baseline, 6 months, 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Rotator Cuff Tears (PRCTs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673055
- Sponsor's protocol ID
- M20260472
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with external researchers. All participant-related data will be securely stored in the central electronic data capture system of the study team, strictly following medical ethics, privacy protection regulations and relevant data management rules. Only the study investigators, designated data managers and authorized reviewers from the ethics committee and data monitoring committee have access to the raw IPD. Summary study results will be published in peer-reviewed journals and presented at academic conferences in accordance with the pre-set dissemination plan.
Publications
Lafrance S, Charron M, Roy JS, Dyer JO, Fremont P, Dionne CE, Macdermid JC, Tousignant M, Rochette A, Doiron-Cadrin P, Lowry V, Bureau N, Lamontagne M, Sandman E, Coutu MF, Lavigne P, Desmeules F. Diagnosing, Managing, and Supporting Return to Work of Adults With Rotator Cuff Disorders: A Clinical Practice Guideline. J Orthop Sports Phys Ther. 2022 Oct;52(10):647-664. doi: 10.2519/jospt.2022.11306. Epub 2022 Jul 26.
PubMed 35881707
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency Short-course Extracorporeal Shock Wave Therapy for Partial Rotator Cuff Tears: Study Protocol for a Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07673055
- Acronym / sponsor ID
- M20260472
- Conditions
- Partial Rotator Cuff Tears (PRCTs)
- Keywords
- Partial rotator cuff tears, Extracorporeal shock wave therapy, High-frequency short-course therapy, Shoulder pain, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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). Group 3 (Conventional group/control): Receive ESWT once a week for 7 consecutive weeks (7 sessions in total within 7 weeks). Eligibility Criteria Inclusion Criteria Aged 30 to 70 years, regardless of gender. Diagnosed with partial-thickness rotator cuff tear or small non-retracted full-thickness rotator cuff tear via MRI or high-resolution ultrasound. Shoulder pain lasting for at least 3 months, with a pain score (VAS) of 4 points or higher (0-10 scale). Voluntarily join the study and sign written informed consent, and agree to complete all treatments and follow-up visits. Exclusion Criteria Severe full-thickness rotator cuff tear, tendon retraction above Grade II, or greater tuberosity bone cyst. Severe muscle fatty infiltration of the shoulder (Goutallier grade ≥3) shown on MRI. Poorly controlled diabetes, hypothyroidism, or heavy long-term smoking. Received local injections (corticosteroids, platelet-rich plasma etc.) on the affected shoulder within the past 4 weeks. Combined with severe shoulder osteoarthritis, frozen shoulder, shoulder instability, rheumatoid arthritis, bleeding disorders or coagulation problems. Pregnant or breastfeeding women; patients with cardiac pacemakers or tumors at the treatment site (contraindications for ESWT). Unable to finish the full course of treatment or follow-up arrangements. Recruitment Scale \& Centers A maximum of 300 participants will be enrolled from 10 tertiary hospitals nationwide, including Peking University Third Hospital, Beijing Chao-Yang Hospital, West China Hospital of Sichuan University and other renowned medical institutions. The recruitment period lasts from January 2026 to December 2027.
- Combined Care \& Follow-up Arrangements All participants will receive unified guidance on daily activity adjustment and home rehabilitation exercises. Oral pain-relieving anti-inflammatory drugs are allowed and will be recorded, while other physical therapies (ultrasound, laser, massage etc.) are prohibited during treatment. Follow-up time points: Baseline (before treatment), 3 months, 6 months and 12 months after treatment. At each follow-up, researchers will assess pain degree, shoulder function and joint mobility. MRI and ultrasound re-examinations will be conducted at baseline, 6 months and 12 months to evaluate tendon healing. All adverse reactions during treatment and follow-up will be recorded in detail.
- Evaluation Indicators Primary indicator: Changes of shoulder pain score (VAS) from baseline to 3 months after intervention. Secondary indicators: Shoulder function scores (ASES, Constant-Murley Score) and active/passive joint range of motion. Imaging indicators: Changes of tendon signal-to-noise ratio, tear size and tendon thickness detected by MRI and ultrasound. Treatment adherence: The proportion of participants who complete the scheduled treatment sessions. Safety indicators: Types, quantity and severity of adverse events (local redness, swelling, skin petechiae, transient pain aggravation etc.). Patients' overall subjective evaluation of symptom improvement.
- Study Strengths \& Implementation Notes To avoid assessment bias, the staff responsible for evaluating curative effects and reading imaging images will not know which treatment group each participant belongs to. All operating procedures, assessment standards and imaging measurement methods are unified across all participating hospitals to ensure data accuracy and consistency. This study is the first multicenter trial comparing high-frequency short-course ESWT and conventional regimens for partial rotator cuff tears. It combines subjective symptom scores and objective imaging biomarkers to obtain reliable clinical evidence. After the trial ends, the research team will form a set of optimized ESWT application specifications, which will be promoted to clinical departments such as rehabilitation and sports medicine to provide a better non-surgical treatment option for patients with partial rotator cuff tears.
- Ethical Statement The study strictly follows the Declaration of Helsinki and clinical trial norms. The protocol has passed the ethical review of all participating hospitals. All participants have the right to withdraw from the study at any time without penalty. Personal medical information of all participants will be encrypted and kept confidential to protect privacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency short-course extracorporeal shock wave therapy (ESWT) | Experimental | 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: ConvParticipants 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. |
| High-frequency intensive ESWT | Experimental | 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: ConvParticipants 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. |
| Conventional ESWT (Active Comparator) | Active comparator | 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: ConvParticipants 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: ConvArm 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) | Device | Conventional ESWT (Active Comparator), High-frequency intensive ESWT, High-frequency short-course extracorporeal shock wave therapy (ESWT) |
Primary outcome
Change in 100-mm Visual Analog Scale (VAS) score for shoulder pain
Time frame: 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.
4 secondary outcomes
American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, 3 months, 6 months, 12 months post-treatment
Constant-Murley Score (CMS)
Time frame: Baseline, 3 months, 6 months, 12 months post-treatment
Shoulder Range of Motion (ROM)
Time frame: Baseline, 3 months, 6 months, 12 months post-treatment
MRI Signal-to-Noise Ratio (SNR) of Rotator Cuff Tendon
Time frame: Baseline, 6 months, 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 35881707Lafrance S, Charron M, Roy JS, Dyer JO, Fremont P, Dionne CE, Macdermid JC, Tousignant M, Rochette A, Doiron-Cadrin P, Lowry V, Bureau N, Lamontagne M, Sandman E, Coutu MF, Lavigne P, Desmeules F. Diagnosing, Managing, and Supporting Return to Work of Adults With Rotator Cuff Disorders: A Clinical Practice Guideline. J Orthop Sports Phys Ther. 2022 Oct;52(10):647-664. doi: 10.2519/jospt.2022.11306. Epub 2022 Jul 26.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with external researchers. All participant-related data will be securely stored in the central electronic data capture system of the study team, strictly following medical ethics, privacy protection regulations and relevant data management rules. Only the study investigators, designated data managers and authorized reviewers from the ethics committee and data monitoring committee have access to the raw IPD. Summary study results will be published in peer-reviewed journals and presented at academic conferences in accordance with the pre-set dissemination plan.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Partial Rotator Cuff Tears (PRCTs), run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiali Xue, Dr (+86 18483638915, 390231882@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 100-mm Visual Analog Scale (VAS) score for shoulder pain (time frame: Baseline (pre-treatment) and 3 months after completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07673055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.