Everts 2008.
Methods | Randomised controlled trial: participants were allocated after randomisation derived from sealed envelopes. It is not clear how the randomisation sequence was generated. Participants and assessors were blinded to the intervention. Trial conducted: no details available; recruitment: no details available |
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Participants |
Participants: 40 undergoing open surgery for shoulder impingement syndrome Included participants: impingement syndrome (stage II), diagnosed at least 6‐months preoperatively. Participants with typical anterior shoulder pain during elevation, loss of active and passive shoulder motion and positive response to 3 subacromial infiltrations (local anaesthetics and corticoids) performed in a 6‐month period Excluded participants: presence of rotator cuff injury; frozen shoulder; acromioclavicular joint disorder; glenohumeral joint degenerative arthritis; shoulder instability; shoulder and elbow disorders; hand disorders; post‐traumatic disorder; participants with diseases that would affect post‐operative wound healing or who were treated for acute shoulder dysfunction Age: PRT group mean (SD): 52 years (11) No PRT mean (SD): 50 years (14) Gender: PRT group (number of men:women): 7:8 No PRT (number of men:women): 5:10 Sports activity: not available |
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Interventions | All participants underwent open subacromial decompression PRT (number of participants = 20): single intraoperative platelet‐leucocyte gel application. From 52 mL blood, 12 mL used to prepare intervention. Citrate dextrose and autologous thrombin were used for gel formation PRT preparation: kit: Magellan Autologous Platelet Separator System (MAPS) Quantification of platelet concentrates after preparation: 1183 SD 396/109/L, 5.7‐fold increase from baseline No PRT (number of participants = 20): no platelet‐rich therapy controls Co‐interventions: same rehabilitation protocol both groups |
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Outcomes | ASES (American Shoulder and Elbow Surgeons scoring system) VAS ADL Shoulder range of motion Use of pain medication |
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Other quality issues |
Sample size: the authors did not calculate the sample size Validation of PRT: quantification reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Drew random numbers |
Allocation concealment | Low risk | Used sequentially‐numbered, opaque and sealed envelopes |
Blinding All outcomes | Low risk | Participants and assessors were blinded to the intervention |
Incomplete outcome data addressed All outcomes | Low risk | No participants were lost to follow‐up |
Free of selective reporting | Unclear risk | The study protocol was not available. It appears that the study’s prespecified primary and secondary outcomes that are of interest in the review have been reported in the prespecified way |
Free of other bias | Low risk | The study appears to be free of other sources of bias |