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

NCT06372600 | Not Yet Recruiting

• 1 other identifier: 2023-181
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tendinitis; Rotator Cuff Tendinosis

Keywords

Rotator cuff calcifying tendinitis; PRP; ESW

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• American Shoulder and Elbow Surgeon's Form,ASES

  After 1, 2, 4 and 8 weeks of intervention

• the university of California at Los Angeles shoulder rating scale, UCLA

  After 1, 2, 4 and 8 weeks of intervention

• The location and size of the calcifications were examined by ultrasound

  After 4 and 8 weeks of intervention

Study Arms (3)

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.

Device: Extracorporeal shock wave therapy device

Platelet-rich plasma group

EXPERIMENTAL

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Biological: Platelet-rich plasma

Extracorporeal shock wave therapy+Platelet-rich plasma group

EXPERIMENTAL

Extracorporeal shock wave therapy followed by Platelet-rich plasma injection

Device: Extracorporeal shock wave therapy device; Biological: Platelet-rich plasma

Interventions

Extracorporeal shock wave therapy device 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.

Extracorporeal shock wave therapy group; Extracorporeal shock wave therapy+Platelet-rich plasma group

Platelet-rich plasma BIOLOGICAL

Autologous Platelet-rich plasma injection was performed under ultrasound guidance

Extracorporeal shock wave therapy+Platelet-rich plasma group; Platelet-rich plasma group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiali Xue: lead

Related Publications (1)

• 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.

  PMID: 39294797 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Chengdu Sport University Xiali Xue

CONTACT

+86 28 8509 4700; 390231882@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 20, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share