SHOULDER & ELBOW
Hydrodilatation, corticosteroids and adhesive capsulitis: A randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):149 BMC Musculoskelet Disord. 2008 Apr 19;9:53.76 patients diagnosed with adhesive capsulitis, having predominantly 1 shoulder pain for >3 months in the last 2 years, were randomized to undergo hydrodilatation with corticosteroid injection or just corticosteroid intra-articular injection. This study aimed to compare the clinical results between techniques. At 6 weeks, no major significant between-group differences in most of the outcome measures were recorded. There was a similar degree of improvement from baseline in both of the treatment groups, hence questioning the role of hydrodilation in management of adhesive capsulitis.
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。
2/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
5/5
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？
Evidence has suggested that the etiology of patients with adhesive capsulitis may result from the contractions of the shoulder and intraarticular adhesions. Hydrodilatation of the glenohumeral joint has thus been advocated for improvement of shoulder pain and range of motion in these patients. However, evidence remains inconclusive due to methodological issues. This study investigated the effect of hydrodilatation on the overall treatment effects of a combined dilatation and steroid injection procedure.
主な研究課題は何ですか？
Are there clinical differences between patients receiving dilatation (DIL) with a corticosteroid and patients receiving Injection (INJ) of a corticosteroid in the treatment of adhesive capsulitis?
重要な知見は？
- Both groups had comparable clinical improvements in Shoulder Pain and Disability Index (SPADI), passive range of motion (PROM) and active range of motion (AROM) from baseline (p>0.05).
- The mean difference in SPADI scores from baseline was 3 points (95% CI: -5 to 11) favouring the DIL group (p>0.05).
- 13 and 9 patients in the INJ and DIL groups, respectively, reported flushing or disturbances with heat regulation. 20 and 14 patients, respectively, reported pain upon injection.
最も覚えておくべきことは？
Similar improvements from baseline in Shoulder Pain and Disability Index (SPADI), passive range of motion (PROM) and active range of motion (AROM) were observed in both the hydrodilatation and control groups.
それが私の患者ケアにどのように影響するか？
The results indicated that hydrodilatation did not provide any additional clinical benefits in patients with adhesive capsulitis, but may have an important treatment effect in some selected cases. Therefore, there is a need for future trials investigating the long-term effects of hydrodilatation.
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