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Effect of PRP as Therapy for Shoulder Osteoarthritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05043493
Enrollment
91
Registered
2021-09-14
Start date
2021-03-01
Completion date
2021-08-03
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Osteoarthritis

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.

Interventions

PROCEDUREInjection in the intraarticular space of glenohumeral joint

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in patient's pain score2 weeks after each injectionBy 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

MeasureTime frameDescription
change in the range of motion2 weeks after each injectionThis 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

MeasureTime frameDescription
change in the use of analgesic medication2 weeks after each injectionamount of analgesia that needed to inhibit pain, is the patient still in need to pain medication , or he cease it .

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026