Clinical study of the influence from the platelet rhich plasma (PRP) application on the therapy of the impingement syndrome (IS) of the shoulder

Not Applicable

• Conditions: M75.4; M75.5; M75.1; Impingement syndrome of shoulder; Bursitis of shoulder; Rotator cuff syndrome

• Registration Number: DRKS00013326
• Lead Sponsor: Otto-von-Guericke-Universität MagdeburgUniversitätsklinik für Orthopädie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Study Completion: 2021-02-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Age> 18 years regardless of gender
- Age <65 LJ
- Voluntary participation (consent given)

Arm 1:
- IS complaints <2 months
- No pretreatment
- Radiological criteria (X-ray / MRI)
- Bursitis subacromialis / subdeltoidea
- Tendopathy of RM
- RM partial rupture type A, B according to Ellmann I-II °
- Outlet-IS (acromion spur, osteoarthritis of the acromio-clavicular joint)

Arm2:
Control group: Patients who received a local subacriomal injection of bupivacaine 0.5% due to shoulder IS in the outpatient setting at the Department of Orthopedics, in addition to physiotherapeutic and physical applications. (The data of these patients were collected from 2016 to 2017 retrospectively.)

Exclusion Criteria

• Specific shoulder diseases
- Complete, transmural RM rupture
- Shoulder instability (habitual, post-official)
- Omarthrosis
• systemic inflammatory diseases (rheumatoid arthritis, fibromyalgia)
• Indication of disturbed pain processing or psychosomatic underlying illness
• local previous operations
• neurological / muscular diseases
• chronic pain patients
• longer conservative pretreatment (> 6 weeks) and previous local injections
• Age <18 years
• Reference to pension requests
• Pregnant / breastfeeding women
• Contraindications for percutaneous intervention (insufficient coagulation status, etc.)
• existing infectious diseases
• low platelet haematological oncological diseases such as leukemias, myelodysplastic syndromes, malignant lymphomas, anemias
Patients who are at increased risk for side effects (e.g., in a greatly reduced condition)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Evaluation of the therapeutic effect of PRP (platelet-rich plasma) application in the treatment of IS by the application of clinical established scores (Constant-Murley-Score)<br><br>- Before the therapy:<br>• Evaluation of clinical findings using established scores (Constant-Murley-Shoulder-Score)<br>• onetime X-ray of the shoulder in 3 levels as routine standard diagnostic of the IS of the shoulder<br>• onetime MRI shoulder as a routine standard diagnostic of the IS of the shoulder<br><br>- Outcome parameters:<br>• Evaluation of clinical findings using established scores (Constant-Murley-Shoulder-Score) after 6 weeks, 3 month and 6 months<br>• Patient-specific concentration determination of thrombocytes and growth factors from the obtained PRP on the day of treatment

Secondary Outcome Measures

Name	Time	Method
- Comparison of clinical outcomes with existing clinical data from a group of patients receiving subacromial injection with bupivacaine including the Constant-Murley-Shoulder-Score<br>- Comparison of clinical results with previous data based on a literature review