Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis

Rotator Cuff Tendinitis Clinical Trial

Official title:

Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06372600
• Other study ID #: 2023-181
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2025
• Est. completion date: February 20, 2026

Study information

• Verified date: April 2024
• Source: Chengdu Sport University
• Contact: Chengdu Sport University Xiali Xue
• Phone: +86 28 8509 4700
• Email: 390231882[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 patients; pain and return to normal life as soon as possible.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 20, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

Device:
• Extracorporeal shock wave therapy device
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.

Biological:
• Platelet-rich plasma
Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiali Xue

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 1, 2, 4 and 8 weeks of intervention
Secondary	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.	After 1, 2, 4 and 8 weeks of intervention
Secondary	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.	After 1, 2, 4 and 8 weeks of intervention
Secondary	The location and size of the calcifications were examined by ultrasound		After 4 and 8 weeks of intervention