HAND & WRIST
Night-time splinting after fasciectomy or dermo-fasciectomy for Dupuytren's contracture: a pragmatic, multi-centre, 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. 2014;2(5):16 BMC Musculoskelet Disord. 2011 Jun 21;12:136. doi: 10.1186/1471-2474-12-136154 patients with Dupuytren's disease were randomized to receive hand therapy either with or without nightly splinting for 6 months following fasciectomy or dermofasciectomy, in order to determine if splinting provided a beneficial effect to patients 1 year postoperatively. Patients were primarily assessed with the Disabilities of the Arm, Hand, and Shoulder questionnaire, and secondarily through total active flexion, total active extension, and patient satisfaction. The results of the study reflected no significant differences between the primary outcome or any of the secondary outcomes, and that there was no beneficial effect of nightly splinting combined with hand therapy.
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
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？
Dupuytren's disease is commonly treated with fasciectomy or dermofasciectomy. The most appropriate postoperative rehabilitation protocol following these procedures remains controversial. The use of thermoplastic extension splints is advocated by some authors, whereas others have reported negative results with the use of splinting following surgery. Therefore, this study aimed to evaluate the effect of static night splinting in addition to hand therapy compared to hand therapy alone.
主な研究課題は何ですか？
Did combined static night splinting with hand therapy following fasciectomy for Dupuytren's disease improve patient-reported function and disability, active range of motion of the digits, patient satisfaction and recurrence rate of contracture compared to hand therapy alone, measured over 1 year postoperatively?
重要な知見は？
- A total of 21 patients of the non-splint group received splinting, 8 of which were protocol violations: One patient received splinting by mistake prior to randomization and 7 patients were given splinting at first hand therapy session due to surgeon request. 13 patients developed contractures between first and second hand therapy sessions fitting the per protocol deviation criteria (all at PIPJ).
- Intention to treat analysis of 12-month outcome assessment of splint group versus no splint group indicated no significant differences in DASH score (Mean 7.0 vs 6.0, Adjusted difference 0.66 (95%CI -2.79 to 4.11), p=0.703), total active flexion (223.8 degrees vs 227.3 degrees, -2.02 (-7.89 to 3.85), p=0.493), total active extension (-32.9 degrees vs -29.6 degrees, 5.11 (-2.23 to 12.55), p=0.172) and patient satisfaction (8.5 vs 8.9, -0.35 (-1.04 to 0.34), p=0.315). Non-significant difference between groups was also reflected in 3 and 6 month assessments.
- A per-protocol analysis was also performed due to the number of per protocol deviations, as well as to account for patients with adherence to treatment <50% in first 3 months. No statistically significant differences in primary and secondary outcomes were found between groups in 3-, 6- and 12-month assessment of the per-protocol analysis.
- Adherence to splint wear in the first 3 months of treatment was 74.6% (SD 29.4%) of nights. 12 patients failed to meet the adherence criterion (>50% of nights for first 3 months).
最も覚えておくべきことは？
The addition of nightly static splinting to hand therapy in the first 6 months following fasciectomy or dermofascietomy did not significantly improve patient-reported function/disability, range of motion of operated digits, or patient satisfaction compared to hand therapy alone in patients suffering from Dupuytren's disease.
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 there is no additional benefit to routine nightly splinting in functional and satisfaction outcomes following surgical treatment of Dupuytren's disease; however, patients who develop postoperative contracture, especially in the early postoperative period, should still be treated with splinting.
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