Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Visual Analogue Scale,VAS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Visual Analogue Scale,VAS
Time Frame: After 1, 2, 4 and 8 weeks of intervention
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.
Secondary Outcomes
- the university of California at Los Angeles shoulder rating scale, UCLA(After 1, 2, 4 and 8 weeks of intervention)
- American Shoulder and Elbow Surgeon's Form,ASES(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)
Investigators
Xiali Xue
Clinical Professor
Chengdu Sport University