Effect of PRP as Therapy for Shoulder Osteoarthritis

• ClinicalTrials.gov Identifier: NCT05043493
• Recruitment Status: Completed
• First Posted: September 14, 2021
• Last Update Posted: September 14, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Osteoarthritis	Procedure: Injection in the intraarticular space of glenohumeral joint	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: July 30, 2021
• Actual Study Completion Date: August 3, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Change in patient's pain score [ Time Frame: 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 :

1. change in the range of motion [ Time Frame: 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.

Other Outcome Measures:

1. change in the use of analgesic medication [ Time Frame: 2 weeks after each injection ]
   amount of analgesia that needed to inhibit pain, is the patient still in need to pain medication , or he cease it .

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Ainshams University

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

• Study Director: Amr Abd Elfatah, proffeseor; department of anesthesia ,ICU, and pain management ASU

More Information

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05043493
• Other Study ID Numbers: ASU 000017585
• First Posted: September 14, 2021
• Last Update Posted: September 14, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases