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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06372600
Enrollment
60
Registered
2024-04-18
Start date
2025-06-01
Completion date
2026-02-20
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tendinitis, Rotator Cuff Tendinosis

Keywords

Rotator cuff calcifying tendinitis, PRP, ESW

Brief 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.

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.

Interventions

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.

BIOLOGICALPlatelet-rich plasma

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Sponsors

Xiali Xue
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale,VASAfter 1, 2, 4 and 8 weeks of interventionThe 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.

Secondary

MeasureTime frameDescription
American Shoulder and Elbow Surgeon's Form,ASESAfter 1, 2, 4 and 8 weeks of interventionThe 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.
the university of California at Los Angeles shoulder rating scale, UCLAAfter 1, 2, 4 and 8 weeks of interventionFull 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.
The location and size of the calcifications were examined by ultrasoundAfter 4 and 8 weeks of intervention

Contacts

Primary ContactChengdu Sport University Xiali Xue
390231882@qq.com+86 28 8509 4700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026