ARTHROPLASTY
I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(10):2 BMC Musculoskelet Disord. 2012 Jun 6;13:88. doi: 10.1186/1471-2474-13-8830 patients undergoing total knee arthroplasty (TKA) were randomized into either a pulsed electromagnetic field (PEMF) group, using I-ONE stimulator, or a control group. At 1, 2, 6, and 12 months after surgery, the Knee-Score, SF-36 and VAS outcomes were significantly better in the experimental group compared to the control group. PEMF group reduced joint swelling and consumed less non-steroidal anti-inflammatory drugs (NSAIDs).
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
2/4
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？
Osteoarthritis (OA) is a degenerative joint disease that affects approximately 10% of adults over the age of 50. Total knee arthroplasty (TKA) is a common procedure performed to treat it; however, it results in inflammation and pain, which reduces patient's mobility and alters posture. Although standard and accelerated rehabilitation protocols are used, their long term benefits are still unclear. In patients with joint arthroplasty, biophysical stimulation with pulsed electromagnetic field (PEMFs) exerts an anti-inflammatory effect, hence promoting early functional recovery and providing long-term benefits. The trial sought to evaluate the effect of PEMF on patients’ recovery and pain relief.
主な研究課題は何ですか？
Compared to the control group, can PEMF treatment, added to standard rehabilitation, limit pain and joint swelling, as well as shorten the functional recovery 12 months after TKA?
重要な知見は？
- Knee scores were greater in both groups than the baseline values, with significant difference at 2, 6 and 12 months (p<0.05) in PEMF group and only at 6 and 12 months in the control group (p<0.05). In intergroup analysis, the score for PEMF group was significantly higher after 2 months (p<0.0001) and 6 months (p<0.0001) than in the controls. At 12 months, no difference was found between groups (p = 0.097).
- The Functional Score significantly increased compared to the baseline at 2 months (p<0.05) in PEMF group, while only after 6 months in the control group; no statistical significant difference was present between the groups 1 month after surgery (p = 0.124), however, a significant difference was found at 2 months (p<0.0001), 6 months (p<0.0001) and 12 months (p<0.005) between groups.
- SF36 health survey score a month after TKA in the PEMF group was higher than in the control (p<0.0001) and the baseline (p<0.05). The difference was maintained at 2 months (p<0.0001), 6 months (p<0.0001) and 12 months (p<0.05).
- VAS values were significantly lower in PEMF group than the control group at all follow-ups: 1 month (p<0.0001), 2 months (p<0.0001), 6 months (p<0.001) and 12 months (p<0.05).
- Swelling decreased significantly in both groups with respect to baseline (p<0.05), with no difference between groups at 6 and 12 months. At 1 and 2 months after surgery, the percentage of patients with mild to moderate swelling was significantly higher in PEMF group compared to the control group (p<0.05 and p<0.0001).
- -A month after TKA, 33% of PEMF group used NSAIDs, in contrast to 93% of the control group (RR = 8.11 C.I. 1.23-53.57, p = 0.0017). At 2 months, 7% PEMF group used NSAIDs vs. 86 % of control group (RR = 7.39 C.I. 2-27.26, p<0.0001), and at 6 months 7% vs. 46% (RR = 2.57 C.I. 1.31-5.06, p<0.05). However, at 12 months, no difference was found.
最も覚えておくべきことは？
The use of a pulsed electromagnetic field device, in addition to the standard rehabilitation, expedited the functional recovery and reduced pain and swelling of the knee compared to the control group. There were no adverse events related to the use of the pulsed electromagnetic field device.
それが私の患者ケアにどのように影響するか？
PEMF is a useful treatment in patients suffering from TKA knee pain and should be considered for inclusion in post-surgical treatment. Further studies should investigate the cost-effectiveness of this treatment method and establish a comparison to a placebo control group.
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