HAND & WRIST
A prospective randomized controlled trial comparing night splinting with no splinting after treatment of mallet finger
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(15):10 Hand (N Y). 2014 Jun;9(2):145-5059 patients (>18 years of age) who were diagnosed with mallet finger (with or without fracture) and who had undergone continuous splint/cast immobilization and hyper-extension intervention (6-8 weeks), were randomly assigned into 1 of 2 treatment groups to determine the effect of an additional one month of night splinting on extensor lag. Participants either received an additional one month intervention with a night splint following their continuous splinting period or received no additional intervention (control). Results from the study demonstrated that no significant differences existed between the two groups by final follow-up when comparing the final extensor lag, disability, or treatment satisfaction experienced by patients.
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。
3/4
Randomization
2/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
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？
Following the occurrence of mallet finger, a variety of adverse events can occur, with the most prominent event being extensor lag. The effect night splinting has on this adverse event following a continuous splinting period (6 to 8 weeks) is currently unknown, and so, the goal of this study was to determine if there is any positive correlation between the two.
主な研究課題は何ですか？
After 6-8 weeks of continuous splint or cast immobilization for mallet finger, is there a difference in residual extensor lag between those who continued intervention with nightly splinting for 1 month versus those who did continue with nightly splinting?
重要な知見は？
- Average extensor lag experienced by patients within the study was 14 degrees (range 0 to 42). 6 patients in the night splint group and 8 in the control group had final extensor lag of 20 degrees or greater. The difference between groups regarding this outcome was not significantly different (p>0.05).
- Final extensor lag significantly correlated with age (p=0.006), final FIP flexion (p=0.005), enrollment extensor lag (p=0.001), and enrollment DIP flexion (p=0.014).
- Enrollment lag and follow-up DIP flexion accounted for 28% of the variation in final extensor lag (p<0.001).
- Mean DASH score and satisfaction levels were comparable between the two groups at final follow up (p=0.67 and 0.48, respectively). Mean DASH among participants in the study was 8.8 (range 0 to 54) by final follow up and, 8.2 with regard to satisfaction score (range 0 to 10).
最も覚えておくべきことは？
No significant differences existed between the two groups by final follow up when comparing final extensor lag, disability, or treatment satisfaction. Significant correlations between extensor lag and age, enrollment distal interphalangeal joint (DIP) flexion and extensor lag, and final DIP flexion was observed.
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 supplemental night splitting does not improve the outcome of mallet finger with regard to extensor lag, disability, or treatment satisfaction. Patient preference should be considered in decision-making processes. Further research with a larger sample size and longer follow up period is warranted.
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