Effect of PRP as Therapy for Shoulder Osteoarthritis

Not Applicable

Completed

• Conditions: Shoulder Osteoarthritis
• Interventions: Procedure: Injection in the intraarticular space of glenohumeral joint

• Registration Number: NCT05043493
• Lead Sponsor: Ain Shams University

Brief Summary

Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.

Detailed Description

Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .

Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.

The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-03-01
• Study First Submitted: 2021-07-18
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-03
• Study First Submitted QC: 2021-09-12
• Last Update Submitted: 2021-09-12
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Patient's age: From 21 years.
• Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
• Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
• Numerical Rating Scale for pain scores greater than five on a 10 scale

Read More

Exclusion Criteria

• Under 21 years of age
• Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
• Neuropsychiatric disorders.
• Immunocompromised patients.
• Active infection or malignancy at the joint.
• Pregnancy and breastfeeding.
• Patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy.
• Shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection (study) group	Injection in the intraarticular space of glenohumeral joint	This group will receive platelet rich plasma (PRP) injection
Control group	Injection in the intraarticular space of glenohumeral joint	This group will receive normal saline (NS) injection

Primary Outcome Measures

Name	Time	Method
Change in patient's pain score	2 weeks after each injection	By using NUMERICAL PAIN SCALE patient will mention them pain score on scale from 1 to 10, where the pain score to be included in the study is 5 and more , we will measure pain score for each patient after 2 weeks from injection ,where decrease of the number from the initial recorded number before injection means improvement.

Secondary Outcome Measures

Name	Time	Method
change in the range of motion	2 weeks after each injection	This out come will be evaluated by physiotherapist using a device called a goniometer. A goniometer is a metal or plastic handheld device with two arms. Numbers representing angular distance are on the device, The physiotherapist measures the initial angular distance before the injection, and after the injection by 2 weeks Normal range of active movement of the shoulder has been specified by the American Academy of Orthopedic Surgeons (AAOS) to be 180° for flexion and abduction and 90° for external rotation.

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt