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

NCT ID: NCT06372600

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-02-20

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.

Conditions

Rotator Cuff Tendinitis; Rotator Cuff Tendinosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Extracorporeal shock wave therapy group

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.

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy device

Intervention Type: 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.

Platelet-rich plasma group

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Group Type: EXPERIMENTAL

Platelet-rich plasma

Intervention Type: BIOLOGICAL

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Extracorporeal shock wave therapy+Platelet-rich plasma group

Extracorporeal shock wave therapy followed by Platelet-rich plasma injection

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy device

Intervention Type: 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.

Platelet-rich plasma

Intervention Type: BIOLOGICAL

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Interventions

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.

Intervention Type: DEVICE

Platelet-rich plasma

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiali Xue

OTHER

Sponsor Role: lead

Responsible Party

Xiali Xue

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Chengdu Sport University Xiali Xue

Role: CONTACT

390231882@qq.com

+86 28 8509 4700

References

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.

Reference Type: DERIVED

PMID: 39294797 (View on PubMed)

Other Identifiers

2023-181

Identifier Type: -

Identifier Source: org_study_id