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Completed

NCT Number: NCT05043493

Effect of PRP as Therapy for Shoulder Osteoarthritis

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Injection in the intraarticular space of glenohumeral joint

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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