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Pulsed electromagnetic field therapy relieves pain and speeds recovery after TKA
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July 2013
Pulsed electromagnetic field therapy relieves pain and speeds recovery after TKA
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study
BMC Musculoskelet Disord. 2012 Jun 6;13:88. doi: 10.1186/1471-2474-13-88Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
30 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).
Publication Funding Details
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Funding:
Industry funded
Sponsor:
IGEA SpA - Clinical Biophysics
Conflicts:
Company Employee
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
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
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
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?
Study Characteristics
-
Population:
30 patients undergoing total knee arthroplasty (TKA)
Intervention:
PEMF group: Patients underwent standard rehabilitation (kinesitherapy) with the addition of the I-ONE stimulator 4hours/day for 60 days (n=15)
Comparison:
Control Group: Patients underwent standard rehabilitation (kinesitherapy) only (n=15)
Outcomes:
Visual Analogue Scale (VAS), The Knee Society Score, SF-36 Health Survey, Joint Swelling Score, non-steroidal anti-inflammatory drug (NSAID) use.
Methods:
RCT: Prospective; Single-Center
Time:
12 months (follow up at 1,2,6, and 12 months)
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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