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Effect of PRP as Therapy for Shoulder Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05043493
Recruitment Status : Completed
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Information provided by (Responsible Party):
Ain Shams University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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)

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 .

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043493

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Ainshams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
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Study Director: Amr Abd Elfatah, proffeseor department of anesthesia ,ICU, and pain management ASU
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Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT05043493    
Other Study ID Numbers: ASU 000017585
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases