FOOT & ANKLE
A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(10):12 Foot Ankle Int. 2014 Mar;35(3):201-6186 patients with a severe lateral ankle sprain (type III) were randomized to treatment to 3 weeks of rigid immobilization with a walking boot followed by 3 weeks of immobilization with a functional brace, or to a functional brace for 6 weeks. The purpose was to compare these two conservative treatment methods for outcomes in pain, function, and ankle stability up to 12 weeks after the injury. AOFAS scores were better for the first 6 weeks in patients receiving the functional brace, and pain and comfort outcomes also benefited within the first few weeks from using a functional brace. By 12 weeks, ankle stability was re-established effectively and similarly between the two groups.
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。
1/4
Randomization
2/4
Outcome Measurements
4/4
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？
Despite lateral ankle sprains causing ligament ruptures being one of the most prevalent presentations in either the emergency room or orthopaedic office, debate among practitioners and residents still exists on both classification of the injury and the most effective means to treat it. Traditionally, injuries of this nature have been treated using rigid immobilization for 3 weeks, subsequently followed by protection using a functional brace for another 3 weeks. However, there has been growing interest in whether using a functional brace initially, and foregoing rigid immobilization, may provide patients with earlier functional return and comparably good final results.
主な研究課題は何ですか？
How do two conservative treatment methods - rigid immobilization for 3 weeks followed by functional brace immobilization for 3 weeks, or functional brace use only - compare, with respect to pain intensity, function, recovery and instability following a severe lateral ankle sprain?
重要な知見は？
- At 1 week, no significant differences were noted between groups in edema intensity, average VAS pain, or weight-bearing capacity. A significant difference in comfortability (p=0.029) and AOFAS scores (p=0.00003) was noted between groups, both favouring Group B.
- Irrespective of group allocation, AOFAS score at 1 week were lower among participants with 3 ligamentous lesions.
- At 3 weeks, groups did not significantly differ in either pain location or weight-bearing capacity. At this time point, AOFAS scores remained significantly higher in Group B (84.8 +/- 8.8 vs. 79.5 +/- 9.2; p=0.00004), and patients of Group B had missed fewer days from work (3.9 +/- 2.7 vs. 7.0 +/- 3.8; p<0.01). Pain intensity at 3 weeks did not clinically differ between groups (Group A 1.7 +/- 1.2; Group B 1.4 +/- 1.2).
- At 6 weeks, the only significant difference that was noted between groups was a higher AOFAS in Group B (94.3 +/- 6.6 vs. 90.5 +/- 10.6; p=0.027). Anterior drawer tests were normal in all patients but 1 at 6 weeks.
- At 12 weeks, no significant differences were observed between groups. At this time, articular stability was assessed using varus stress and anterior drawer stress X-rays, with no differences noted between contralateral and affected sides.
最も覚えておくべきことは？
Treatment of a lateral ankle sprain with a functional brace was associated with increased comfort over the first 3 weeks and slightly better functional outcome over 6 weeks when compared to treatment with a walking boot followed by a functional brace. Both treatment methods resulted in restoration of normal ankle stability within 6 weeks. Short-term functional outcome of extensive ligament injuries (three injured ligaments) was lower than less severe injuries, regardless of allocated treatment.
それが私の患者ケアにどのように影響するか？
Either treatment method included in this study appears to effectively re-establish ankle stability following a type III lateral ankle sprain characterized by gross instability. Immobilization with a functional brace from the initiation of treatment appears to confer similar efficacy to rigid immobilization with a walking boot, and may even be more comfortable for patients. Short-term pain and function also somewhat benefited with the functional brace. The long term stability implications of these two treatment methods should be determined.
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