HAND & WRIST
Safety and efficacy of platelet-rich plasma in treatment of carpal tunnel syndrome; a randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2019;7(3):23 BMC Musculoskelet Disord. 2018 Feb 13;19(1):4941 women with carpal tunnel syndrome were randomized to 8 weeks of nightly splinting with or without the addition of a single injection of platelet-rich plasma. Patients were followed up after 10 weeks from the beginning of treatment for results related to pain, outcome on the Boston Carpal Tunnel Questionnaire, and electrophysiological measures of peak latency of sensory nerve action potential (PL-SNAP) and onset latency of the compound muscle action potential (OL-CMAP). Results demonstrated no significant differences between the PRP group and the control group for any of the outcome measures assessed.
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。
4/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/5
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？
The interest in platelet-rich plasma in the management of various orthopaedic and musculoskeletal surgeries and conditions have increased considerably in the past decades. Nonetheless, its efficacy in the management of individuals with carpal tunnel syndrome has not been previously tested.
主な研究課題は何ですか？
In women with carpal tunnel syndrome, does the addition of a single platelet-rich plasma injection to 8 weeks of splint wear have a significant effect on pain, function, or electrophysiological measures at 10 weeks after treatment initiation, as compared to 8 weeks of splint wear alone?
重要な知見は？
- Reduction in VAS pain after 10 weeks did not significantly differ between the PRP group (-2.76+/-2.4) and the control group (-2.90+/-2.1) (p=0.845).
- Reduction in BCTQ Symptom Severity score after 10 weeks did not significantly differ between the PRP group (-0.72+/-0.7) and the control group (-0.70+/-0.3) (p=0.922). Reduction in BCTQ Functional score after 10 weeks also did not significantly differ between the PRP group (-0.63+/-0.8) and the control group (-0.86+/-0.5) (p=0.289).
- Reduction in PL-SNAP after 10 weeks did not significantly differ between the PRP group (-0.17+/-0.2) and the control group (-0.15+/-0.2) (p=0.820).
- Reduction in OL-CMAP after 10 weeks did not significantly differ between the PRP group (-0.04+/-0.2) and the control group (-0.09+/-0.1) (p=0.410).
最も覚えておくべきことは？
In the treatment of women with carpal tunnel syndrome, the addition of a single injection of platelet-rich plasma to 8 weeks of nightly splinting did not have a significant effect on change in pain, function, or electrophysiological measures over 10 weeks when compared to patients managed with nightly splinting alone.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that a single platelet-rich plasma injection does not add any significant benefit to nightly splinting treatment for women with mild-to-moderate carpal tunnel syndrome. Given the small evidence base on the use of PRP in carpal tunnel syndrome treatment, additional randomized controlled trials should be considered.
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