SHOULDER & ELBOW
Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(16):17 BMC Musculoskelet Disord. 2016 May 26;17(1):232.106 patients with adhesive capsulitis were randomized to one of three groups to determine which mode of conservative therapy - corticosteroid injections with distension, corticosteroid injections only, or treatment-as-usual (verbal education, use of other conservative therapy) - was associated with the greatest improvement in shoulder pain, function, and range of motion on the short-term (4 and 8 weeks) and long-term (12 months). Results demonstrated that patients in both corticosteroid injection intervention groups had significant improvements in pain, function, abduction, internal rotation, and external rotation when compared to the usual treatment group when assessed at 4 and 8 weeks. Long-term improvements in any outcome measure (12 months) between all groups and efficacy between the two intervention groups were comparable when evaluated.
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
3/4
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？
Adhesive capsulitis, also known as "frozen shoulder", is diagnosed as a long-lasting condition characterized by recurrent onset of pain, progressive stiffness, and reduced shoulder range of motion. These symptoms are further associated with interference in activities of daily living and increased dependency by the elderly. Several modes of conservative therapy have been developed to address and mitigate these symptoms (ie. nonsteroidal anti-inflammatory drugs, intraarticular glucocorticosteroid injections, physical therapy, and manipulation under anaesthetic and hydrodilation), however recent study has been largely unsuccessful in finding an optimal treatment modality. Therefore, the aim of this study was to determine the short- and long-term effects of multiple corticosteroid injections with distension, when compared to injection alone or treatment-as-usual.
主な研究課題は何ですか？
For patients with adhesive capsulitis, how does conservative treatment with either corticosteroid injections and distension, corticosteroid injections alone, or standard treatment compare in improved pain, disability, and passive range of motion when assessed throughout a 12-month follow-up period?
重要な知見は？
- Both intervention groups were observed with significant improvement in SPADI when compared to the TAU group at 4 and 8 weeks (IS vs. TAU MD=-20.8 [28.9 to -12.7], p<0.001 | ISD vs. TAU MD= -21.7 [-29.4 to -14.0], p<0.001); significant was not maintained at 12 months. Additionally, differences in SPADI scores between IS and ISD groups were not significant.
- Both intervention groups were observed with significant improvement in NPRS scores when compared to the TAU group at 4 and 8 weeks (IS vs. TAU MD=-2.0 [-2.8 to -1.1], p<0.001 | ISD vs. TAU MD= -2.2 [-3.0 to -1.4], p<0.001); differences in NPRS scores between IS and ISD groups were not significant.
- Patients in the IS group (MD=8.3 [2.3 to 14.3]) and the ISD group (MD=12.8 [6.6 to 18.9]) were observed with significantly greater improvement in abduction when compared to the TAU group at 4 and 8 weeks (p=0.01 and p=0.001 respectively).
- Patients in the IS group (MD=10.8 [5.8 to 15.9]) and the ISD group (MD=11.9 [6.8 to 17]) were observed with significantly greater improvement in internal rotation when compared to the TAU group at 4 and 8 weeks (p=0.001 for both).
- Patients in the IS group (MD=5.0 [2.8 to 7.2]) and the ISD group (MD=5.1 [2.9 to 7.2]) were observed with significantly greater improvement in external rotation when compared to the TAU group at 4 and 8 weeks (p=0.001 for both).
- Differences in all measurements of passive range of motion (abduction, internal rotation, and external rotation) were not significant between all three groups, or when intervention groups were compared to the TAU group, at 12 months.
- 17% and 12% of patients in the IS and ISD group respectively experiences minor transitory side effects (including flushing and after-pain); no other minor or adverse effects were observed.
最も覚えておくべきことは？
For patients undergoing conservative treatment for adhesive capsulitis, use of corticosteroid injection with or without distension was associated with significantly improved pain, function, and range of motion when compared to the treatment-as-usual (TAU group) at 4 and 8 weeks. However, when assessed at 12 months, outcomes scores were comparable between study groups. Additionally, differences between pain, function and range of motion outcomes never reached statistical significance when the two corticosteroid injection intervention groups were compared throughout the study.
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 corticosteroid injection treatment, with or without distention, may provide patients with significant short-term reduction of adhesive capsulitis symptoms when compared to usual treatment. Nevertheless, outcome after 1 year does not appear to differ between treatment option. Further randomized controlled trials are needed to verify consistent short-term benefit of corticosteroid injection, with or without distension, in cases of adhesive capsulitis. Additionally, methods offered in the treatment-as-usual group were heterogenous, with the possibility remaining that there may be differences depending on specific control interventions.
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