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Clinical Trials/NCT05043493
NCT05043493
Completed
Not Applicable

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

Ain Shams University1 site in 1 country91 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Osteoarthritis
Sponsor
Ain Shams University
Enrollment
91
Locations
1
Primary Endpoint
Change in patient's pain score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
August 3, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

  • change in the range of motion(2 weeks after each injection)

Study Sites (1)

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