Rotator Cuff Injuries
Conditions
Keywords
corticosteroid, platelet rich plasma, tendinopathy, partial thickness tear
Brief summary
Randomized controlled trial examining platelet rich plasma versus corticosteroid injection in partial thickness rotator cuff tears or tendinopathy.
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.
Interventions
BIOLOGICALPlatelet Rich Plasma (PRP)
RegenLab, Lausanne, Switzerland
40mg/ml triamcinolone in 2 ml 0.5% bupivicaine
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Subjects, assessors, and the PI were blinded to the assigned treatment allocation.
Intervention model description
Two arm parallel randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | change from baseline at 6 weeks, 3 months, 12 months | visual analog scale for pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons shoulder score (ASES) | change from baseline at 6 weeks, 3 months, 12 months | ASES score |
| Western Ontario Rotator Cuff Index (WORC) | change from baseline at 6 weeks, 3 months, 12 months | WORC score |
| Failure | anytime from injection out to 12 months | 1\) patient request for a subsequent injection, 2) consent for surgical repair, 3) undergoing surgery |
| Anatomic changes | 3 months and 12 months post injection | ultrasound evidence of progression to a full thickness tear |
Outcome results
None listed