Effect of PRP as Therapy for Shoulder Osteoarthritis

NCT05043493 | Completed

• 1 other identifier: ASU 000017585
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in patient's pain score

  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.

  2 weeks after each injection

Secondary Outcomes (1)

• change in the range of motion

  2 weeks after each injection

Other Outcomes (1)

• change in the use of analgesic medication

  2 weeks after each injection

Study Arms (2)

Injection (study) group

ACTIVE COMPARATOR

This group will receive platelet rich plasma (PRP) injection

Procedure: Injection in the intraarticular space of glenohumeral joint

Control group

PLACEBO COMPARATOR

This group will receive normal saline (NS) injection

Procedure: Injection in the intraarticular space of glenohumeral joint

Interventions

Injection in the intraarticular space of glenohumeral joint PROCEDURE

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

Control group; Injection (study) group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Amr Abd Elfatah, proffeseor

  department of anesthesia ,ICU, and pain management ASU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: September 14, 2021
• Study Start: March 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 3, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)