Effect of PRP as Therapy for Shoulder Osteoarthritis

NCT ID: NCT05043493

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-08-03

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.

Conditions

Shoulder Osteoarthritis

Study Design

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

Study Groups

Injection (study) group

This group will receive platelet rich plasma (PRP) injection

Group Type: ACTIVE_COMPARATOR

Injection in the intraarticular space of glenohumeral joint

Intervention Type: PROCEDURE

U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)

Control group

This group will receive normal saline (NS) injection

Group Type: PLACEBO_COMPARATOR

Injection in the intraarticular space of glenohumeral joint

Intervention Type: PROCEDURE

U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)

Interventions

Injection in the intraarticular space of glenohumeral joint

U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)

Intervention Type: PROCEDURE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amr Abd Elfatah, proffeseor

Role: STUDY_DIRECTOR

department of anesthesia ,ICU, and pain management ASU

Locations

Ainshams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ASU 000017585

Identifier Type: -

Identifier Source: org_study_id