FOOT & ANKLE
Mechanical supports for acute, severe ankle sprain: A pragmatic, multicentre, randomised controlled trial
This report has been verified
by one or more authors of the
original publication.
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これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(4):12 Lancet. 2009 Feb 14;373(9663):575-81584 patients with severe ankle sprains were recruited from eight emergency departments to assess the effectiveness of three different bracing options and to compare them with a tubular compression brace. Patients were randomized to treatment with a below-knee cast, an Aircast brace, Bledsoe boot, or tubular compression brace. At three month follow-up, there was a significant improvement in the Foot and Ankle scores of the below-knee casting and Airbrace groups in comparison to the tubular compression brace. There were no differences between groups at a nine month follow-up.
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
3/4
Inclusion / Exclusion
2/4
Therapy Description
4/4
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?
Severe ankle sprains are a common occurrence. Current treatment methods for this injury vary greatly, with no consensus on a gold standard. High-quality evidence is lacking on determining the most effective method. Immobilization devices is one of such treatment methods; however, it has not been studied extensively. Thus, this study assessed treatment using a variety of support methods and compared them to a common treatment - the tubular compressive bracing.
主な研究課題は何ですか?
Were the clinical outcomes of three mechanical supports for severe ankle sprains (Air cast, Bledsoe boot, and 10 day knee cast) different from a double-layer tubular compression bandage, when measured at 9 months?
重要な知見は?
- The tubular compression bandage was the least effective treatment brace, in terms of improvements in Foot and Ankle scores
- Clinically important benefits occurred at 3 months in the below-knee cast group when compared with the tubular compression bandage for FAOS quality scores (Mean difference: 9%; 95% CI: 2.4-15.0%; p<0.007). Differences were also demonstrated in FAOS pain, symptoms, and activities of daily living subscales.
- Similar FAOS quality scores were seen in the Aircast group (Mean difference: 8%; 95% CI: 1.8 -14.2%; ES: 0.33) and the below-knee cast (Mean difference: 9%; 95% CI: 2.4-15.0%; ES: 0.36) at 3 months. These scores were better than those in the tubigrip and Bledsoe groups.
- Pertaining to the SF-12 scores, patients in the Aircast and Bledsoe groups had better mental health-related quality of life, in comparison to the other 2 groups at 3 months.
- There were no differences in outcomes between any of the groups at 9 months.
最も覚えておくべきことは?
Results from this study indicated that both below-knee casting and the Aircast brace were superior treatments for severe ankle sprains, as treatments provided significant improvements in Foot and Ankle scores at 3 months when compared to a tubular compression brace.
それが私の患者ケアにどのように影響するか?
Based on the results from this study patients presenting with severe ankle sprains are advised to undergo short term immobilization treatment using either a 10 day below-knee cast or an Aircast brace. It may be beneficial to determine whether additional treatments such as physiotherapy or surgery are useful adjuncts to mechanical supports, and the optimal time for application.
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