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Comparison of single-dose radial extracorporeal shock wave and local corticosteroid injection for treatment of carpal tunnel syndrome including mid-term efficacy: a prospective 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. 2019;7(7):4 BMC Musculoskelet Disord. 2018 Jan 25;19(1):3225 patients with carpal tunnel syndrome were randomized to treatment with either a single session of radial extracorporeal shockwave therapy or a single corticosteroid injection. Primary outcome was the Boston Carpal Tunnel Questionnaire, including both the Symptoms and Functional scores. Patients were assessed at 1, 4, 12, and 24 weeks after treatment. Within-group reductions from baseline in BCTQ scores were significant from 4 weeks to 24 weeks in the rESWT group, in contrast to only 1 week to 4 weeks in the corticosteroid injection group. The reduction in scores from 12 weeks to 24 weeks were significantly greater in the rESWT compared to the corticosteroid injection for each of the BCTQ total score, Symptoms subscore, and Functional subscore.
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
3/5
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？
Carpal tunnel syndrome is a common condition, with a number of studies performed on its incidence in both working and elderly populations. Corticosteroid injections are often administered prior to consideration of surgery, though long-term effectiveness of this option has been questioned. A more recent modality in conservative management is extracorporeal shockwave therapy (ESWT), with particular interest in radial ESWT as opposed to focused ESWT. However, comparative efficacy of rESWT and corticosteroid injection has not been previously studied in a randomized controlled trial.
主な研究課題は何ですか？
In treatment of carpal tunnel syndrome, how does disease-specific pain and function compare between patients administered a single dose of radial extracorporeal shockwave therapy vs. patients administered a single injection of triamcinolone, assessed over 24-week follow-up?
重要な知見は？
- Reduction in total BCTQ score from baseline was statistically significant within the rESWT group after 4, 12, and 24 weeks, and within the corticosteroid injection group after 1 week only. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
- Reduction in BCTQ Symptom score from baseline was statistically significant within the rESWT group after 4, 12, and 24 weeks, and within the corticosteroid injection group after 1 and 4 weeks. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
- Reduction in BCTQ Functional score from baseline was statistically significant within the rESWT group after 12 and 24 weeks, and within the corticosteroid injection group at no follow-up time point. When comparing between groups, the reduction in score from 12 weeks to 24 weeks was significantly greater in the rESWT group compared to the corticosteroid injection group (p=0.015).
- Reduction in VAS pain score from baseline was statistically significant within the rESWT group after 12 and 24 weeks, and within the corticosteroid injection group at no follow-up time point.
- Both groups demonstrated significant reduction in peak sensory distal latency from baseline to 12 weeks, while neither group demonstrated a significant change in SNAP amplitude, motor distal latency, or CMAP amplitude.
最も覚えておくべきことは？
In treatment of carpal tunnel syndrome, one session of radial extracorporeal shockwave therapy demonstrated significant reduction in disease-specific pain and functional limitation relative to pre-treatment values after 12 and 24 weeks, and demonstrated significantly greater reduction in disease-specific pain and functional limitation between 12 and 24 weeks when compared to that achieved by a single corticosteroid injection.
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 one session of radial extracorporeal shockwave therapy may possess greater therapeutic efficacy for reducing symptomatic pain and functional limitation associated with carpal tunnel syndrome when compared to a single corticosteroid injection. A particular limitation is the small study size, with data from only 25 patients. Further studies should be planned with a large sample of patients. In the current study, differences in efficacy did not appear until 12- to 24-week follow-up, suggesting more maintained reduction in symptoms over time with rESWT in contrast to early onset of relief generally seen within corticosteroid injection. The duration of efficacy following rESWT should be studied in future studies, as 24 weeks is likely not sufficient enough to identify regression in efficacy and potential return of symptoms.
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