Krogh 2013.
Methods | Randomised controlled trial: endpoint assessors and participants were blinded to the procedure. Allocation sequence controlled by randomisation performed as blocks of 6 participants. Study's outcomes were measured at 3 months Trial conducted: Diagnostic Centre, Region Hospital Silkeborg, Silkeborg, Denmark; recruitment: from January 2009‐July 2010 |
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Participants |
Participants: 40 with elbow lateral epicondylitis Included participants: participants with symptoms for more than 3 months Excluded participants: participants < 18 years old; treated with glucocorticoid injection in previous 3 months; previous tennis elbow surgery; inflammatory diseases; neck pain on the ipsilateral side and chronic pain syndromes Lateral epicondylitis defined as pain on the lateral side of the elbow for at least 3 months, pain at the lateral epicondyle on direct palpation and during resisted dorsiflexion of the wrist. Ultrasonography was also performed at the origin of the extensor tendon; required a definite sign of tendinopathy with colour Doppler flow of at least grade 2 at baseline Age: PRT group mean (SD): 47.6 years (7.1) No PRT mean (SD): 44.7 years (7.9) Gender: PRT group (number of men:women): 9:11 No PRT (number of men:women): 9:11 Sports activity: not available |
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Interventions | All participants underwent platelet‐rich plasma or glucocorticoid or saline ultrasound‐guided single injection. A blood sample was collected from all participants, and all interventions were prepared out of the reach of the participant PRT (number of participants = 20): PRP: 3.0‐3.5 mL PRP derived from 27 mL blood. Blood was centrifuged at 3200 rpm for 15 minutes, before the addition of 3 mL citrate. Bicarbonate was added to the PRP to achieve physiological pH. PRT preparation: Recover GPS II system (Biomet Biologics Inc, Warsaw, Indiana) Quantification of platelet concentrates after preparation: 8‐fold (compared with whole blood) No PRT (number of participants = 20): saline (3 mL of 0.9%) Co‐interventions: same rehabilitation protocol for both groups |
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Outcomes | Pain section of the PRTEE questionnaire Functional disability of the PRTEE questionnaire Safety (adverse events) Injection‐related pain Ultrasound assessment: colour doppler changes and tendon thickness |
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Other quality issues |
Sample size: the authors calculated the sample size based on the PRTEE pain domain at 12 months (we expect that this based on another population) Validation of PRT: quantification reported |
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Notes | We excluded all the analyses relating to glucocorticoid intervention (not considered as placebo) The authors provided the study protocol/trial registration details, ID: NCT 01109446 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Used permuted blocks of 6 participants |
Allocation concealment | Low risk | Used sequentially‐numbered, opaque and sealed envelopes |
Blinding All outcomes | Low risk | The participant and outcome assessors were blinded to the treatment, but the treating physician was not |
Incomplete outcome data addressed All outcomes | High risk | Only 13 out of 40 participants in the 2 groups completed 12 months' follow‐up |
Free of selective reporting | High risk | The study protocol is not available and the clinical follow‐up period was short for participants who underwent elbow tendinopathy treatment |
Free of other bias | Low risk | The study appears to be free of other sources of bias |