IRCT2013052313442N1.
| Trial name or title | A randomised controlled trial: comparing the effectiveness of ultrasound guided injection of platelet rich plasma and shoulder physiotherapy on pain and function of patients with partial thickness rotator cuff tears |
| Methods | Study design: randomised trial Random sequence generation: not reported Allocation concealment: not reported Masking: not blinded |
| Participants | Location: not reported Target sample size (N): 40 Inclusion criteria: established rotator cuff tear (traumatic or degenerative) on MRI that should not be massive or full thickness in the radiologist's report; shoulder pain or dysfunction at a level of severity that makes the participant seek a medical intervention or surgery; all participants should have failed 2‐week treatments with NSAIDs and 6 weeks of physical therapy; provide written informed consent Exclusion criteria: pregnancy or active breastfeeding; presence of a tumour, metastatic disease, active infections; platelet count < 100,000 per μL or Hgb < 10 g/dL; gross instability of the glenohumeral joint; superior labral lesions requiring surgical repair; people with painful cervical spine pathology; previous surgery on the shoulder joint; national‐ or international‐level athletes |
| Interventions |
PRP: ultrasound guided, 3 mL PRP and 2 mL lidocaine injected directly into rotator cuff at the site of tear. Preparation must contain a platelet count of 100,000 per unit or be 5 times the basal level of the normal platelet count Controls or placebo or no intervention (standard care): 15 sessions of shoulder physiotherapy |
| Outcomes | Primary outcomes: Constant score; VAS Secondary outcomes: WORC Timing of outcomes measurement: 4, 8, 12 weeks |
| Starting date |
Main ID: IRCT201011205214N1
Date of registration: June 2011 Last refreshed on: July 2013 Date of first enrolment: December 2010 Status: complete |
| Contact information | Name: Dr Ramin Kordi Address: The Sports and Exercise Medicine Research Centre, Jalal Al Ahmad street, opposite the Shariati Hospital, Tehran, Tehran, Islamic Republic Of Iran Telephone: +98 2188 630227 Email: ramin_kordi@tums.ac.ir Affiliation: The Sports and Exercise Medicine Research Centre |
| Notes |