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Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma (PRP) | Experimental | 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. |
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| Corticosteroid (CS) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma (PRP) | Biological | RegenLab, Lausanne, Switzerland |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | visual analog scale for pain | change from baseline at 6 weeks, 3 months, 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian KY Lo, MD | University of Calgary | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33127554 | Background | 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. |
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No individual participant data will be made available.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 6, 2021 | |
| Reset | Nov 4, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 6, 2021 | Nov 4, 2021 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Two arm parallel randomized controlled trial
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Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
| Corticosteroid (CS) |
| Drug |
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine |
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| 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 |
| D009135 |
| Muscular Diseases |
| D009140 | Musculoskeletal Diseases |