Effect of PRP as Therapy for Shoulder Osteoarthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Osteoarthritis
• Intervention / Treatment: Procedure: Injection in the intraarticular space of glenohumeral joint

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Injection (study) group; This group will receive platelet rich plasma (PRP) injection	Procedure: Injection in the intraarticular space of glenohumeral joint; U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)
Placebo Comparator: Control group; This group will receive normal saline (NS) injection	Procedure: Injection in the intraarticular space of glenohumeral joint; U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Amr Abd Elfatah, proffeseor, department of anesthesia ,ICU, and pain management ASU

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: July 18, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: ASU 000017585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No