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

Xiali Xue

Status

Not yet enrolling

Conditions

Rotator Cuff Tendinitis

Rotator Cuff Tendinosis

Treatments

Biological: Platelet-rich plasma

Device: Extracorporeal shock wave therapy device

Study type

Interventional

Funder types

Other

Identifiers

NCT06372600

2023-181

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 3 patient groups

Extracorporeal shock wave therapy group

Experimental group

Description:

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.

Treatment:

Device: Extracorporeal shock wave therapy device

Platelet-rich plasma group

Experimental group

Description:

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Treatment:

Biological: Platelet-rich plasma

Extracorporeal shock wave therapy+Platelet-rich plasma group

Experimental group

Description:

Extracorporeal shock wave therapy followed by Platelet-rich plasma injection