SPORTS MEDICINE
Do Capacitively Coupled Electric Fields Accelerate Tibial Stress Fracture Healing? A Randomized Controlled Trial
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):210 Am J Sports Med. 2008 Mar;36(3):545-53. Epub 2007 Nov 3050 patients with acute posteromedial tibial stress fractures were randomized to either receive active capacitively coupled electric stimulation (CCEF) or placebo treatment. This study aimed to evaluate the fracture healing capacity of CCEF. The results indicated that treatment with CCEF stimulation did not result in accelerated healing of tibial stress fractures compared with the placebo treatment. However, electrical stimulation treatment was more effective when there was increased compliance and less weight bearing. Additionally, evidence from this study suggested that treatment with CCEF stimulation for severe stress fractures resulted in an improved time to heal compared to placebo treatment.
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。
3/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
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？
Stress fractures result from repeated application of subfracture threshold forces and are defined as a focal structural weakness in the bone. These injuries frequently occur in military and athletic populations. Chronic skeletal overloading in which there is not enough time for bone to adapt appropriately is the main cause of fracture development. These injuries have the ability to heal spontaneously if the fracture site is not exposed to load; however, it is not optimal for training individuals. There has been limited investigation into the most optimal treatment for this injury and the existing evidence is not adequate or significant. The use of electric stimulation has been shown to accelerate the process of bone formation in vitro; however, the theory that electric stimulation may result in stress fracture healing has not yet been tested in a randomized controlled trial.
主な研究課題は何ですか？
What is the effect of capacitively coupled electric field (CCEF) stimulation on the rate of tibial stress fracture healing compared to placebo treatment, in patients with tibial stress fractures measured until the time of fracture healing?
重要な知見は？
- In terms of time to healing, there was no significant difference between the active treatment and placebo groups (29 vs. 25.9 days, respectively).
- Overall, women healed more slowly compared to the men (31 vs. 23 days, P=0.05).
- Increased compliance with the treatment was related to a greater reduction in time to healing in the active treatment group than in the placebo group (P=0.003).
- Rest non-compliance (increased participation in weight bearing activities during treatment) resulted in an increased time to healing, for the active treatment group compared to the placebo (P=0.05).
- The healing rates of subjects with bone scan severity grades of >2 vs. <2 in the treatment group were 23.5 +/- 16.3 days and 31.2 +/- 22.0 days, respectively (no significant difference). However, with respect to the placebo groups these values were 48.0 +/- 36.8 days and 24.4 +/- 8.7 days; P=0.01.
最も覚えておくべきことは？
Treatment with capacitively coupled electric field (CCEF) stimulation did not accelerate tibial stress fracture healing when the total sample was assessed (both sever and less severe fractures). However, CCEF stimulation resulted in more effective healing when there was greater compliance and reduced weight bearing. As well, the above results suggested that more severe fractures, treated with the active device, healed faster than the placebo group.
それが私の患者ケアにどのように影響するか？
This study indicates that capacity coupled electric field stimulation does not improve healing time for patients with tibial stress fractures. Further studies are required to assess possible positive benefits identified by this trial. CCEF stimulation may be more beneficial to patients with severe stress fractures, and increased compliance with CCEF treatment may provide superior outcomes.
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