The Effect of Platelet Rich Plasma on Partial Thickness Rotator Cuff Tears: A Randomized Controlled Trial (PRP)

Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Biological: Platelet Rich Plasma (PRP); Drug: Corticosteroid (CS)

Detailed Description

We performed a randomized controlled trial on patients with imaging-shown rotator cuff tendinopathy or partial thickness tearing. Patients were randomized to receive either platelet rich plasma or corticosteroid. Follow-up was done at 6 weeks, 3 months and 12 months following injection.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 years
• MRI or US evidence of supraspinatus tendinopathy or partial thickness tearing
• symptomatic for minimum of 3 months
• patient has exhausted a course of adequate conservative treatment (including but not limited to home/out patient physical therapy, oral analgesics, and/or shoulder injections)

Exclusion Criteria:

• prior surgical intervention on affected shoulder
• full thickness rotator cuff tear
• concomitant ipsilateral shoulder pathology (i.e. osteoarthritis, inflammatory arthritis)
• confounding cervical neck pain or radiculopathy
• more than 3 previous CS injections
• a CS injection within 6 months of study intervention
• elite level athlete
• worker's compensation case
• litigation or secondary gain issues
• unwilling or unable to provide informed consent or complete study outcomes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet Rich Plasma (PRP); Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. Injection was 3-5ml at the site of tendon pathology with the remainder of the PRP preparation infiltrated into the subacromial space. A leukocyte-poor preparation was used from a pre-packaged kit (RegenLab, Lausanne, Switzerland). The samples were centrifuged at 1500g for 5 mins to yield approx 5.5ml of 80% platelets at 1.6x concentration. The supernatant was then resuspended by inverting the tube several times and was drawn into a separate 5-ml syringe for subacromial injection.	Biological: Platelet Rich Plasma (PRP); RegenLab, Lausanne, Switzerland
Active Comparator: Corticosteroid (CS); Patients had 10ml venous blood drawn. Injection was performed under ultrasound guidance by one of two musculoskeletal radiologists. The blood sample was kept for a similar time delay for centrifugation prior to injection, and was then discarded. 1ml of 40-mg/ml triamcinolone was suspended in 2ml of 0.5% bupivicaine. Injection was performed through a lateral subacromial approach after needle fenestration of the supraspinatus tendon under ultrasound visualization. CS was infiltrated into the subacromial bursa and not the tendon itself.	Drug: Corticosteroid (CS); 40mg/ml triamcinolone in 2 ml 0.5% bupivicaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	visual analog scale for pain	change from baseline at 6 weeks, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons shoulder score (ASES)	ASES score	change from baseline at 6 weeks, 3 months, 12 months
Western Ontario Rotator Cuff Index (WORC)	WORC score	change from baseline at 6 weeks, 3 months, 12 months
"Failure"	1) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery	anytime from injection out to 12 months
Anatomic changes	ultrasound evidence of progression to a full thickness tear	3 months and 12 months post injection

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Ian KY Lo, MD, University of Calgary

Publications and helpful links

General Publications

• Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2015
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: corticosteroid; platelet rich plasma; tendinopathy; partial thickness tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REB14-0570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No