SHOULDER & ELBOW
External rotation immobilization for primary shoulder dislocation: a randomized controlled trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(21):35 Clin Orthop Relat Res. 2014 Aug;472(8):2380-6. doi: 10.1007/s11999-013-3432-6.60 patients with a primary anterior glenohumeral dislocation were randomized to either immobilization in external rotation or internal rotation, following reduction. This study aimed to determine whether external immobilization reduced the frequency of recurrent instability as compared to internal immobilization. The results at the minimum 12 months' follow-up indicated that rates of recurrent dislocation, instability, and instability requiring surgical intervention were comparable between groups. Additionally, WOSI scores and ROM (between injured and contralateral side) were similar. Difference in ASES scores between groups achieved borderline significance in favour of external immobilization.
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
4/4
Outcome Measurements
3/4
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？
Dislocation of the shoulder is a common injury affecting the glenohumeral joint. In the young and active population, recurrent instability following conservative treatments for dislocated shoulders remains problematic. Patients are typically immobilized with a sling after reduction but the position in which the arm is immobilized is highly debated. Several studies have demonstrated that external rotation immobilization was efficacious in reducing rates of recurrence while contrasting results were indicated in a separate study with a larger population. Therefore, this study was aimed to compare recurrence rates and quality of life outcomes between external and internal immobilization.
主な研究課題は何ですか？
Does immobilization in external rotation reduce the frequency of recurrent instability and yield better disease-specific quality-of-life scores, when compared to immobilization in internal rotation, in patients with a primary anterior glenohumeral dislocation assessed at a minimum of 12 months?
重要な知見は？
- Rate of recurrent dislocation at the minimum 12 months' follow-up was 6/27 (or 22%) in the external group and 8/25 (or 32%) in the internal group. No significant difference was observed between groups (p=0.42).
- Rate of recurrent instability at the minimum 12 months' follow-up was also not significantly different between groups. Rates were 10/27 (or 37%) in the external group and 10/25 (or 40%) in the internal group (p=0.82).
- Rate of recurrent instability requiring surgical stabilization was 6/27 (or 22%) and 7/25 (28%) in the external and internal groups respectively. No significant between group difference was observed (p=0.63).
- ASES score activities of daily living at the minimum 12 months' follow-up favoured in the external group (95; SD 5), over the internal group (89; SD 14) (p=0.05).
- WOSI scores did not differ significantly between groups. Scores averaged 87% (SD 14) and 84% (SD 21) in the external and internal groups, respectively (p=0.74).
- ROM (injured side vs. contralateral side) averaged 70 vs. 76 degrees in the external group and 76 vs. 78 degrees in the internal group. This difference between groups did not reach statistical significance (p=0.15 vs. p=0.67).
- Compliance with brace or sling was similar between groups (Brace: 87% [27/31]; Sling: 83% [24/29])
最も覚えておくべきことは？
Rate of recurrent dislocation, instability, and instability requiring surgical intervention at the minimum 12 months' follow-up did not differ significantly between internal and external rotation immobilization. WOSI scores and ROM were comparable, with ASES scores achieving borderline significance in favour of external immobilization.
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 indicated that immobilization in external rotation following reduction of a primary anterior glenohumeral dislocation did not reduce rates of recurrence as compared to the traditional protocol of immobilization in internal rotation. The small sample size and moderate loss to follow-up in this study, however, indicates a need for further studies.
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