SHOULDER & ELBOW
Optimal dose of intra-articular corticosteroids for adhesive capsulitis: A randomized, triple-blind, placebo-controlled trial
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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. 2013;1(10):33 Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 1863 patients were randomized to determine the effect of varying doses of corticosteroid injections in the treatment of adhesive capsulitis. Participants were allocated to groups of high-dose triamcinolone (40mg), low-dose triamcinolone (20mg), or placebo (control) (1% lidocaine). Results after 12 weeks indicated that pain and disability were more significantly improved with both dosages of corticosteroid compared to control, but there was no difference between 20mg and 40mg triamcinolone. Corticosteroid injections also had a beneficial effect on passive range of motion in flexion, abduction, and internal rotation
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
4/4
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？
Although intra-articular injections of corticosteroid have been and remain a mainstay in the treatment of adhesive capsulitis, there is little evidence available to guide clinician decision-making with respect to dosage. It has been suggested that the efficacy of steroid injections conforms to a dose-dependent relationship, with increasing dose leading to a more favourable outcome. Yet, simultaneously, the severity of cartilage damage linked to corticosteroid injection is also thought to be manifested through the same dose dependency. Therefore, it has become crucial to determine the optimal steroid dosage to use in the treatment of adhesive capsulitis.
主な研究課題は何ですか？
What was the comparative efficacy of 20mg triamcinolone acetonide, 40mg triamcinonlone acetonide, and placebo in adhesive capsulitis treatment?
重要な知見は？
- SPADI scores were reduced from 37.9 (SD 14.2) at baseline to 14.1 (SD 12.4) at 12 weeks in the high-dose group, 37.6 (SD 13.7) to 18.3 (SD 14.0) in the low-dose group, and 44.2 (SD 12.2) to 37.1 (SD 10.4) in the placebo group. Improvements in both the high-dose and low-dose steroid groups were significant compared to placebo (P<0.001 and P=0.001, respectively), although the difference between steroid groups was not significant (P=0.826).
- Marked reductions in VAS pain were observed for the steroid groups; the high-dose group from 5.2 (SD 1.7) at baseline to 2.4 (SD 1.7) at 12 weeks, and the low-dose group from 4.9 (SD 1.3) to 2.4 (SD 1.3). The difference between these two group was not significant (P=0.999). Compared to placebo (reduction from 5.5 to 4.6), both steroid groups were observed to have a significantly greater reduction (High-dose: P<0.001; Low-dose: P=0.001).
- Flexion, abduction, and internal rotation were significantly better in the high- and low-dose groups compared to placebo group (all P<0.005). The difference between the steroid groups was not significant for these measurements, however (P=0.485, 0.092, and 0.495, respectively).
- The group-by-time interactions for extension and external rotation were not significant (P=0.331 and 0.094, respectively), however the group-by-time interactions for SPADI (P=0.007), VAS (P=0.004), flexion (P=0.024), abduction (P<0.001) and internal rotation (P=0.027) were all significant.
- Facial flushing was observed in 3 high-dose participants and 1 low-dose participant. Dizziness due to a vasovagal reaction occurred in 1 patient of the placebo group and 1 in the low-dose group. These were the only complications reported.
最も覚えておくべきことは？
Injection of either 20mg or 40mg triamcinolone acetonide led to significantly reduced pain and disability compared to a control injection in the treatment of adhesive capsulitis. Furthermore, improved range of motion was observed with the corticosteroid injections. There were no differences in outcomes based on dose of triamcinolone acetonide received, and neither dose was associated with any serious adverse event.
それが私の患者ケアにどのように影響するか？
At 12 weeks post injection there appears to be no difference between a lower (20mg) and a higher dose (40mg) of triamcinolone. Given the lack of difference, a lower dose may be considered to avoid any potential complications that may exist with higher doses (even though the study found none). However, further investigation with a larger cohort of patients is required to confirm the efficacies of both high- and low-dose corticosteroid injections. Long-term effect of single injections should also be determined in future studies.
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