Comparison Between Platelet Rich Plasma and Corticosteroids for the Treatment of Rotator Cuff Tendinopathy

NCT06150378 | Completed DMC

• 1 other identifier: 00005269
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test if Plateth-rich plasma would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of corticosterone injections. Researchers will compare a control group of patients treated with a corticosterone injection with a case group of patients treated with Plateth-rich plasma injection. The purpose of this study is to perform a double-blind randomized controlled trial, comparing PRP with corticosteroids to provide pain relief and improve function in patients with rotator cuff tendinopathy. The hypothesis of this study is that PRP would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of CS injections.

Conditions

Shoulder Tendinopaty

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  From 1 (no pain at all) to 10 (worst pain in patient's life)

  1 year

Secondary Outcomes (3)

• ASES (American Shoulder and Elbow Surgeons)

  1 year

• Constant's score

  1 year

• Pittsburgh Score

  1 year

Study Arms (2)

Corticoid

ACTIVE COMPARATOR

Patients that recieve corticosterone injection instead of plathet rich plasma.

Drug: Corticosteroid

Plathet rich plasma

EXPERIMENTAL

Patients that recieve plathet rich plasma instead of corticoesterone

Biological: Plathet rich plasma

Interventions

Corticosteroid DRUG

Patients that receive an injection with corticosteroid

Corticoid

Plathet rich plasma BIOLOGICAL

Patients that receive an injection with Plathet-rich plasma

Plathet rich plasma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• symptomatic rotator cuff tendinopathy (confirmed by ultrasound).
• At least 3 months of failed conservative treatment (decreased activity, anti-inflammatories, kinesiology for at least 3 months before diagnosis).

You may not qualify if:

• Refusal to participate or informed consent
• Previous shoulder surgery,
• Partial or total tears of the rotator cuff,
• Patients with shoulder osteoarthritis
• Advanced fatty infiltration of the rotator cuff muscles
• Systemic or rheumatoid arthritis,
• Uncontrolled diabetes,
• Acute or chronic infections of the shoulder to be operated on
• Ongoing cancer chemotherapy therapies
• Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
• Patients with autoimmune diseases;
• Pregnants

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad de Buenos Aires, Buenos Aires, 1001, Argentina

Location

Related Publications (23)

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  BACKGROUND

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MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: At the time of blood collection, patients will be placed in a hemotherapy extraction chair with a screen that will prevent the patient from seeing their arm at the time of blood collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shoulder surgeon attending, Clinical professor, Principal investigator

Model Details: Randomized Controlled Double Blind Clinical Trial

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: November 29, 2023
• Study Start: September 30, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

AR (1)