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Electric field stimulation may accelerate healing in severe tibial stress fractures
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March 2013
Electric field stimulation may accelerate healing in severe tibial stress fractures
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:1
Do Capacitively Coupled Electric Fields Accelerate Tibial Stress Fracture Healing? A Randomized Controlled Trial
Am J Sports Med. 2008 Mar;36(3):545-53. Epub 2007 Nov 30Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
50 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.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
US Army Medical Research and Materiel Command
Conflicts:
None disclosed
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.
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
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?
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.
What was the principal research question?
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?
Study Characteristics
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Population:
50 patients (n=21 males, n=29 females) with acute posteromedial tibial stress fractures.
Intervention:
Active capacitively coupled electric field stimulation (CCEF): Patients were provided a portable CCEF stimulator (OrthoPak Bone Growth Stimulator Systems). Sinusoidal waves (3-6 V at 60kHs and 5019 mA) were applied through 2 electrodes. Patients were instructed to use the device for 15 hours per day. Standard rehabilitation for stress fractures was provided. (n=24; 8 males, mean age 28.33+/-7.68; 14 females, mean age 27.79+/-7.93)
Comparison:
Placebo: Patients were provided an inactive portable CCEF stimulator. These patients followed the same protocol as intervention patients. (n=26; 11 males, mean age 26.09+/-7.99; 10 females, mean age 23.90+/-6.23).
Outcomes:
The main outcome was the time to healing (healing occurred when subject could hop on the affected limb with no pain, for 30 seconds to a 10 cm height). As well, severity of the fracture was assessed clinically and radiologically. Degree of compliance and amount of weight bearing were recorded.
Methods:
RCT; Double Blind (Assessors and patients)
Time:
The intervention ceased when healing had occurred.
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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