OSTEOARTHRITIS
Intra-articular injection of photo-activated platelet-rich plasma in patients with knee osteoarthritis: a double-blind, randomized controlled pilot study
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(21):11 BMC Musculoskelet Disord. 2016 Feb 9;17(1):6723 patients with mild-moderate knee osteoarthritis were randomized to three weekly intra-articular injections of either hyaluronic acid (HA; Synvisc Hylan G-F 20) or photo-activated platelet-rich plasma (PRP). The purpose of this study was to compare pain and functional outcome between the two groups at 4 and 12 week follow-up after the last injection. Efficacy outcomes included a visual analog scale (VAS) for pain, the Knee Injury and Osteoarthritis Outcome Scale (KOOS), the Knee Quality of Life 26-Item questionnaire (KQoL-26), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and functional performance tests. Findings demonstrated no significant differences between groups at either 4 or 12 week follow-up for any outcome measures. Nonetheless, as this was a pilot study, the trial was underpowered to accurately assess comparative efficacy between treatment options.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
2/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Injection therapies have been increasingly prominent within research regarding treatment of knee osteoarthritis, with numerous randomized controlled trials investigating the efficacy of various products. Of these, popular topics include viscosupplementation with hyaluronic acid, and platelet rich plasma. Specifically regarding PRP, the use of photo-activation has been suggested to possibly heighten efficacy. Nevertheless, there are no RCTs evaluating the use of photo-activated PRP in knee osteoarthritis.
主な研究課題は何ですか？
Are there any significant differences in effect on pain or function between intra-articular injections of photo-activated platelet-rich plasma and hyaluronic acid in patients with knee osteoarthritis, assessed over 3 month follow-up?
重要な知見は？
- There were no significant differences in VAS pain scores between the PRP group and the HA group at either 4 weeks (MD 1.90 [-13..80, 17.60]; p=0.79) or 12 weeks (MD 18.81 [-0.62, 38.24]; p=0.06).
- There were no significant differences in KOOS scores between the PRP group and the HA group for any subscale at 4 and 12 weeks(Symptoms, Pain, Function, Sport, QoL) (all p>0.05).
- There were no significant differences in KQoL-26 scores between the PRP group and the HA group for any subscale at 4 and 12 weeks (Physical, Activity, Emotional) (all p>0.05).
- There were no significant differences in the results of functional performance tests between the PRP group and the HA group at 4 and 12 weeks (all p>0.05).
最も覚えておくべきことは？
In the treatment of mild-moderate knee osteoarthritis, there were no significant differences in results at 4 and 12 week follow-up between three weekly intra-articular injections of photo-activated platelet-rich plasma and hyaluronic acid.
それが私の患者ケアにどのように影響するか？
The findings of this study suggest that short-term effects are similar between photo-activated platelet-rich plasma and hyaluronic acid injection therapies for symptomatic management and functional outcome in patients with mild-moderate knee osteoarthritis. Whether either therapy is truly efficacious in the treatment of this patient population is still unknown, given the mixed previous evidence of hyaluronic acid products in knee osteoarthritis treatment, the lack of placebo-controlled group in the current study, and the pilot nature of the trial. Therefore, additional randomized, placebo-controlled trials are necessary to more accurately quantify and compare the effects of these injection options in patients with knee osteoarthritis.
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