Pulsed electromagnetic field therapy relieves pain and speeds recovery after TKA .
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):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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
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
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
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.
Qual era la domanda di ricerca principale?
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?
- 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.
Che cosa devo ricordare di più?
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.
Come influenzerà l'assistenza ai miei pazienti?
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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