Effect of PRP as Therapy for Shoulder Osteoarthritis

Shoulder Osteoarthritis Clinical Trial

Official title:

Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043493
• Other study ID #: ASU 000017585
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 3, 2021

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 3, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

Procedure:
• Injection in the intraarticular space of glenohumeral joint
U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)

Locations

Country	Name	City	State
Egypt	Ainshams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in the use of analgesic medication	amount of analgesia that needed to inhibit pain, is the patient still in need to pain medication , or he cease it .	2 weeks after each injection
Primary	Change in patient's pain score	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.	2 weeks after each injection
Secondary	change in the range of motion	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.	2 weeks after each injection