PHYSICAL THERAPY & REHAB
Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: A double-blind, randomized, placebo-controlled trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(10):26 BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-8620 patients with non-calcifying supraspinatus tendinopathy (NCST) were randomized to extracorporeal shock wave therapy (ESWT) or to placebo treatment. Physical, roentgenographic, MRI, and blood examinations of the shoulder, conducted at six and at twelve weeks after treatment, showed significantly better results with ESWT treatment in the total Constant and Murley Score (CMS), especially for CMS pain and ROM subscales. ESWT presented no adverse events.
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
Randomização
3/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
3/4
Estatística
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？
Supraspinatus tendinopathy is a common and disabling condition occurring in people after middle age. For the last 20 years, extracorporeal shock wave therapy (ESWT) has been widely used to treat enthesopathies, but a limited number of studies demonstrated effectiveness in non-calcifying supraspinatus tendinopathy (NCST). The following trial wanted to investigate the short-term efficacy and safety of low energy ESWT in patients suffering from chronic NCST.
主な研究課題は何ですか？
Is ESWT effective and safe in reducing pain and improving range of motion in patients with NCST, compared to a placebo, at 6 and 12 weeks after treatment?
重要な知見は？
- At 3 months, the mean relative improvement in total CMS in ESWT group was significantly higher than the placebo (74.5% vs. 15.2%, p = 0.914)
- No adverse events were present, apart from slight pain increase in few patients from the ESWT group.
- ESWT group had significantly higher scores in CMS pain (p=0.039) and CMS ROM (p=0.012) subscales at 3 months.
- The use of pain medication (acetaminophen) in both groups was not significantly different (p=0.16)
最も覚えておくべきことは？
ESWT therapy is effective in short term treatment of NCST and provides improved results in CMS pain and ROM compared to a placebo. The treatment had no adverse effects.
それが私の患者ケアにどのように影響するか？
Low energy ESWT can reduce the pain of people suffering from non-calcifying supraspinatus tendinopathy and can play an important role in successful treatment. More studies with larger sample sizes are required to study this treatments long term effects.
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