Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

NCT05317624 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 0201491
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Shoulder pain assesment

  The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)

  4 months

Secondary Outcomes (5)

• Assesment of rotator cuff tendon healing

  4 months

• Assesment the failure rate after shoulder joint injection

  4 months

• The reinjection rate recording

  4 months

• Assesment the rate of tear recurrence after shoulder joint injection

  4 months

• Simple shoulder assessment test

  4 months

Other Outcomes (4)

• Measurement plasma C-Reactive Protein level

  4 months

• Measurement the fasting blood glucose level

  one week

• Assesment the complications after shoulder joint injection

  4 months

Study Arms (2)

Platelet rich plasma group

EXPERIMENTAL

participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.

Combination Product: Platelet rich plasma

Methylprednisolone group

EXPERIMENTAL

participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.

Combination Product: Methylprednisolone

Interventions

Platelet rich plasma COMBINATION_PRODUCT

platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine

Also known as: PRP group

Platelet rich plasma group

Methylprednisolone COMBINATION_PRODUCT

1ml methyl prednisolone 40mg\\ml mixed with normal saline and bupivacaine

Also known as: steroids group

Methylprednisolone group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with positive tests for rotator cuff pain
• Patients with positive radiological (US or MRI) findings of partial rotator cuff tear

You may not qualify if:

• Patient refusal
• Age less than 20 years.
• Infection at injection site.
• Prior surgery on the shoulder joint area.
• Presence of other associated pathology in the shoulder joint
• Patients using antiplatelet drugs (aspirin).
• Contraindications to the use of platelet concentrate
• Contraindications to the steroids injection

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Facility of medicine

Alexandria, 21519, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dorreya Fikry

  AlexandriaUniversity

  PRINCIPAL INVESTIGATOR

• Tarek Sarhan

  AlexandriaUniversity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radwa saber

Model Details: 2 groups will be included

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: April 8, 2022
• Study Start: August 10, 2021
• Primary Completion: November 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2022-09

Locations

EG (1)