Wasterlain 2013.
Methods | Randomised controlled trial: randomisation sequence was generated by coin toss. Allocation concealment was kept in opaque envelopes that were opened on the day of the intervention. Orthopaedic surgeon and assessors were blinded to the procedure until 26‐weeks follow‐up, except for those for whom the procedure failed. Participants followed for 6 months Trial conducted: Stanford University School of Medicine, California USA; recruitment: October 2009‐June 2012 |
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Participants |
Participants: 23 with patellar tendinopathy Inclusion criteria: > 18 years old; diagnosed patellar tendinopathy; persistence of symptoms after 6 weeks of physical therapy with eccentric exercise Exclusion criteria: previous injection or surgery in the affected knee; inability to complete participant‐reported outcomes Age: PRT group mean (SD): 28 (8) No PRT mean (SD): 40 (14) Gender: PRT group (number of men:women): 8:1 No PRT (number of men:women): 12:0 Sports activity: not available |
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Interventions | Patellar tendon ultrasound‐guided treatment: single dry needling or PRP with the aid of a board‐certified radiologist For both groups, tendinopathy area was penetrated 10 times PRT (number of participants = 10): 55 mL blood resulted in 6 mL leukocyte‐rich PRP, injected into the patellar tendon during the dry needling procedure Quantification of platelet concentrates after preparation: not reported PRT preparation: kit: GPS III (Biomet Inc, Warsaw, IN, USA) No PRT (number of participants = 13): dry needling, as described above, and the 55 ml of blood that had been drawn was discarded Co‐interventions: same post procedure interventions, same rehabilitation protocol |
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Outcomes | VISA Tegner VAS Lysholm SF‐12 |
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Other quality issues |
Sample size: small sample size was powered for VISA, assuming an 13‐point effect size Validation of PRT: quantification not reported |
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Notes | Participants who were not satisfied with the procedure were allowed to receive other treatments. Analyses were performed on an intention‐to‐treat basis The authors provided the study protocol/trial registration details, ID: NCT01406821 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Sequence generated by coin toss |
Allocation concealment | Low risk | Used sequentially‐numbered, opaque and sealed envelopes |
Blinding All outcomes | Low risk | Participants and assessors were blinded |
Incomplete outcome data addressed All outcomes | Low risk | Separate analysis were performed for participants who failed the allocated intervention, as a per protocol analysis and an intention to treat analysis |
Free of selective reporting | Low risk | Data reported as depicted in the study protocol. Short follow‐up |
Free of other bias | Low risk | Patients were permitted to receive other treatments. However, authors performed analysis as intention‐to‐treat |
Abbreviations
> = greater/more than < = less/fewer than ≥ = greater/more than or equal to ACL = anterior cruciate ligament ADL = activities of daily living AJSM = the American Journal of Sports Medicine ASES = American Shoulder and Elbow Surgeons' scoring system BMI = body:mass index BJSM = the British Journal of Sports Medicine CT = computed tomography DASH = Disabilities of the Arm Shoulder and Hand questionnaire IKDC = International Knee Documentation Committee JAMA = Journal of the American Medical Association MRI = magnetic resonance imaging PRF = platelet‐rich fibrin PRFM = platelet‐rich fibrin matrix PRP = platelet‐rich plasma PRT = platelet‐rich therapy PRTEE = Patient‐Related Tennis Elbow Evaluation SF‐12 = the Short Form health survey SST = Simple Shoulder Test UCLA = University of California, Los Angeles score VAS = visual analogue scale VISA = Victorian Institute Sports Assessment VISA‐A = Victorian Institute of Sports Assessment ‐ Achilles questionnaire