Rotator Cuff TendinitisNCT06372600
Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis
A study testing Extracorporeal shock wave therapy device and Platelet-rich plasma in people with Rotator Cuff Tendinitis and Rotator Cuff Tendinosis, run by Xiali Xue.
Trial summary
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tendinitis, Rotator Cuff Tendinosis
- What is being tested?
- Extracorporeal shock wave therapy device and Platelet-rich plasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meet the diagnostic criteria for rotator cuff calcific tendonitis, aged between 40 and 60 years old
- Persistent pain in the affected shoulder, with obvious tenderness under the acromion and rotator cuff, as confirmed by X-ray and Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) examination showed one or more round-shaped high-density calcium salt deposits near the greater tuberosity of the humerus
- All were diagnosed for the first time
- Complaints of severe pain in the shoulder joint, obvious
Who cannot join
- Combined with rotator cuff trauma, long head of biceps tendonitis and other shoulder joint diseases
- Past combined history of shoulder joint surgery
- Patients with internal fixation of the shoulder joint
- Shoulder joint combined with infection, Tumors and other lesions
- Combined with severe heart, liver, and kidney dysfunction
- Do not agree to participate in the study or fail to sign the informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible.
Read the detailed description
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients\' pain and return to normal life as soon as possible.
- Conditions
- Rotator Cuff Tendinitis, Rotator Cuff Tendinosis
- Being tested
- Extracorporeal shock wave therapy device, Platelet-rich plasma
- Keywords
- Rotator cuff calcifying tendinitis, PRP, ESW
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy deviceDevice
In the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 ~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 ~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site.
Platelet-rich plasmaBiological
Autologous Platelet-rich plasma injection was performed under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy group | Experimental | In the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 ~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 ~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site. Receives: Device: Extracorporeal shock wave therapy device |
| Platelet-rich plasma group | Experimental | Autologous Platelet-rich plasma injection was performed under ultrasound guidance Receives: Biological: Platelet-rich plasma |
| Extracorporeal shock wave therapy+Platelet-rich plasma group | Experimental | Extracorporeal shock wave therapy followed by Platelet-rich plasma injection Receives: Device: Extracorporeal shock wave therapy device; Biological: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale,VAS
The full name of the Scale is Visual Analogue Scale, that is, visual analogue scale.
Minimum value and maximum value: the minimum value of the VAS scale is 0, indicating "completely painless" or "painless end"; The maximum value is 10, which indicates "the most severe pain imaginable" or "the most severe pain end." Score Significance: On the VAS scale, a higher score means a worse outcome, i.e. a greater degree of pain. The patient marks the corresponding position on the scale according to their pain experience, thus indicating the intensity of the pain.
Measured: After 1, 2, 4 and 8 weeks of intervention
Secondary outcomes (3)
American Shoulder and Elbow Surgeon's Form,ASES
The full name of the scale: American Shoulder and Elbow Surgeons Score, namely, American Shoulder and Elbow Surgeons Score.
Minimum value and maximum value: The minimum value of ASES scale is 0 and the maximum value is 100.
Score Significance: On the ASES scale, a higher score means a better outcome, i.e. a better functional state of the shoulder or a milder condition.
Measured: After 1, 2, 4 and 8 weeks of intervention
the university of California at Los Angeles shoulder rating scale, UCLA
Full name of the Scale: University of California at Los Angeles Shoulder Rating Scale.
Minimum and maximum values: The minimum value of the UCLA Shoulder Joint Scoring Scale is usually 0, and the maximum value may vary depending on the version and scoring rules, but a common maximum value is 35.
Score Significance: On the UCLA Shoulder Joint Rating Scale, a higher score generally means a better outcome, i.e. better shoulder function or less pain.
Measured: After 1, 2, 4 and 8 weeks of intervention
The location and size of the calcifications were examined by ultrasound
Measured: After 4 and 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion20 Feb 2026 (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 Rotator Cuff TendinitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiali Xue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiali Xue, Chengdu Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372600
- Sponsor's protocol ID
- 2023-181
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient privacy, the investigators have chosen not to share data for the time being.
Publications
Wang X, Jia S, Cui J, Xue X, Tian Z. Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial. Trials. 2024 Sep 18;25(1):616. doi: 10.1186/s13063-024-08407-z.
PubMed 39294797
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06372600
- Acronym / sponsor ID
- 2023-181
- Conditions
- Rotator Cuff Tendinitis, Rotator Cuff Tendinosis
- Keywords
- Rotator cuff calcifying tendinitis, PRP, ESW
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xiali XueUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible.
Detailed description
The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients\' pain and return to normal life as soon as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy group | Experimental | Device: Extracorporeal shock wave therapy deviceIn the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 ~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 ~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site. |
| Platelet-rich plasma group | Experimental | Biological: Platelet-rich plasmaAutologous Platelet-rich plasma injection was performed under ultrasound guidance |
| Extracorporeal shock wave therapy+Platelet-rich plasma group | Experimental | Device: Extracorporeal shock wave therapy device, Biological: Platelet-rich plasmaExtracorporeal shock wave therapy followed by Platelet-rich plasma injection |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for rotator cuff calcific tendonitis, aged between 40 and 60 years old
- Persistent pain in the affected shoulder, with obvious tenderness under the acromion and rotator cuff, as confirmed by X-ray and Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) examination showed one or more round-shaped high-density calcium salt deposits near the greater tuberosity of the humerus
- All were diagnosed for the first time
- Complaints of severe pain in the shoulder joint, obvious
Key exclusion criteria (6 listed)
- Combined with rotator cuff trauma, long head of biceps tendonitis and other shoulder joint diseases
- Past combined history of shoulder joint surgery
- Patients with internal fixation of the shoulder joint
- Shoulder joint combined with infection, Tumors and other lesions
- Combined with severe heart, liver, and kidney dysfunction
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 |
|---|---|---|
| Extracorporeal shock wave therapy deviceIn the shoulder pain points, choose 2 to 3 of them for each treatment, apply the coupling agent, which is convenient for the treatment head to stick to the skin, and complete the longitudinal treatment and horizontal treatment. The setting frequency was 4 ~ 8 Hz, the length of the probe was 15 mm, and the pressure was set at 1.5 mJ/mm2. The frequency of each treatment point reached 2 000 ~ 2 500 times, and the hand-held pressure was set to medium-high level. A total of 6 treatments were completed. For patients with unclear pain points or regional pain, the treatment point should be supraspinatus tendon or infraspinatus tendon, and the treatment should be completed with the most severe pain site. | Device | Extracorporeal shock wave therapy group, Extracorporeal shock wave therapy+Platelet-rich plasma group |
| Platelet-rich plasmaAutologous Platelet-rich plasma injection was performed under ultrasound guidance | Biological | Extracorporeal shock wave therapy+Platelet-rich plasma group, Platelet-rich plasma group |
Primary outcome
Visual Analogue Scale,VAS
Time frame: After 1, 2, 4 and 8 weeks of intervention
The full name of the Scale is Visual Analogue Scale, that is, visual analogue scale. Minimum value and maximum value: the minimum value of the VAS scale is 0, indicating "completely painless" or "painless end"; The maximum value is 10, which indicates "the most severe pain imaginable" or "the most severe pain end." Score Significance: On the VAS scale, a higher score means a worse outcome, i.e. a greater degree of pain. The patient marks the corresponding position on the scale according to their pain experience, thus indicating the intensity of the pain.
3 secondary outcomes
American Shoulder and Elbow Surgeon's Form,ASES
Time frame: After 1, 2, 4 and 8 weeks of intervention
the university of California at Los Angeles shoulder rating scale, UCLA
Time frame: After 1, 2, 4 and 8 weeks of intervention
The location and size of the calcifications were examined by ultrasound
Time frame: After 4 and 8 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 39294797Wang X, Jia S, Cui J, Xue X, Tian Z. Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial. Trials. 2024 Sep 18;25(1):616. doi: 10.1186/s13063-024-08407-z.
- Individual participant dataSharing planned: No. To protect patient privacy, the investigators have chosen not to share data for the time being.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy device and Platelet-rich plasma in people with Rotator Cuff Tendinitis and Rotator Cuff Tendinosis, run by Xiali Xue.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengdu Sport University Xiali Xue (+86 28 8509 4700, 390231882@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale,VAS (time frame: After 1, 2, 4 and 8 weeks 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 NCT06372600, 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 18 Apr 2024.