Do capacitively coupled electric fields accelerate tibial stress fracture healing

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Slide 1 :

Do capacitively coupled electric fields accelerate tibial stress fracture healing? Belinda R. Beck, Ph.D., FACSM1, Gordon Matheson, M.D., Ph.D., FACSM2, Gabrielle Bergman, M.D.3, Andrew Hoffman, M.D.2, Tracey Norling, BHS (HM)1, Robert Marcus, M.D.4. 1Griffith University, Gold Coast, Australia. 2Stanford University, Stanford, CA. 3Franklin & Seidelmann Virtual Radiologists, Chagrin Falls, OH. 4Stanford University, Stanford CA/Eli Lilly, Indianapolis, IN.

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Introduction Stress fractures increasingly affect athletes and military recruits Tibia is most commonly affected bone Healing time can be prolonged No proven strategy to accelerate recovery

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Previous findings Electric fields activate the bone formation process in vitro (Hartig et al., 2000; Brighton et al., 1992) Electric and electromagnetic field stimulation enhances the rate of healing of pseudarthroses (Simmons et al., 2004) and other non-union fractures (Scott and King, 1994; Brighton and Pollack, 1985), in vivo. Lower limb stress fracture healing accelerated when electric field stimulation was introduced (Benazzo et al, 1995)

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Objective To examine the effect of capacitively-coupled electric field stimulation versus placebo on rate of tibial stress fracture (TSF) healing in men and women via a double-blind, randomised, controlled trial

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Methods – subjects convenience sample 18-50 yrs men and women minimum n per group = 8 (x 4 groups = 32) posteromedial tibial stress fractures diagnosis from history and presence of significant focal tenderness, especially loaded

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Methods - measures Evaluation Injury signs/symptoms (intensity rated 1-3): tenderness, night pain, pain with percussion, localized swelling, spongy texture, warmth Imaging (severity graded 1-4) X-ray Triple phase Technetium bone scan MR CT Anthropometrics/Behavioural characteristics age, height, weight, medical history, diet, training patterns, orthopaedic abnormality, menstrual status, BMD, BUA, etc.

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Methods - measures Monitoring Treatment log device use side effects activity Bi-daily symptoms Healing = 30 seconds pain free hopping 10 cm off ground Days to healing from time of injury from time of treatment from Physician Test Meter (Biolectron, Inc., Hackensack, NJ) 24 hour periods

Slide 8 :

Methods - intervention random assignment of active/placebo OrthoPak® Bone Growth Stimulator (EBI, formerly Biolectron, Inc., Hackensack, NJ) treatment 15 hours per day 500 mg supplemental calcium (TUMS 500 Chewable, SmithKline Beecham) acetaminophen prn (Tylenol Extra Strength Gelcaps, 500 mg, McNeil Consumer Products, Fort Washington, PA, USA), and avoidance of NSAIDs no painful weight bearing activities (in saddle cycling and pool running OK)

Slide 9 :

OrthoPak® Bone Growth Stimulator (BIOLECTRON, Inc. Hackensack, NJ, now EBI, Parsippany, NJ) sinusoidal wave 3-6 V 60 kHz 5-10 mA

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Data analysis Treatment effect Two-way ANOVA – Factor 1: device status; Factor 2: sex, DV: healing time Stepwise multiple regression – Variables: age, sex, height, weight, BMI, fracture site, delay from injury to start of intervention, daily calcium consumption, clinical and radiological injury severity, menstrual status, oral contraceptive use, percent fat, percent lean mass, BMD, calcaneal BUA, rest compliance, and device use compliance

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Data analysis Compliance: 2-way ANOVA – Factor 1: Treatment compliance (hours of device use per real treatment days); Factor 2: device status, DV: healing time 2-way ANOVA – Factor 1: Rest compliance (weight bearing activity); Factor 2: device status, DV: healing time t-test – Variable 1: Subjects who complied >70% (used the OrthoPak® for >12.25 hours/day); Subjects who complied <70%

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Subject characteristics a Men > Women, p < 0.05; b Men < Women, p < 0.05 c Female Active > Placebo, p = 0.02; d Female Active < Placebo, p = 0.03

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Results – treatment effects a Females > males (p = 0.04) b Females > males (p = 0.05)

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Results – compliance effects Increased hours device use/day reduced treatment group healing time more than placebo group (F = 57.533, p = 0.003) Time to healing of subjects complying >70% (>12.25 hours/day) was less that those complying <70% (p = 0.009, 95% CI 2.07, 13.797)

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Results – injury severity effects Positive relationship between radiological injury severity and healing time for placebo subjects (Pearson’s r = 0.456, p = 0.03) Clinical and radiological injury severity predicted 98% of healing time in men

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Conclusions TSF treated with electric field stimulation did not heal faster than placebo treated fractures Women took ~ 9 days longer to recover from TSF than men

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Conclusions However: Greater treatment compliance ? enhanced efficacy Greater weight bearing loading during treatment ? poorer efficacy Greater injury severity ? enhanced efficacy Efficacy effects may not be clinically significant

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Interpretation Literature reports TSF healing (12 ±7 weeks or 84 days) vs current healing rate (~ 26 days from treatment/54 days from injury), regardless of device status. Close monitoring, minimised weight bearing loading, Ca++, and no NSAIDS may have optimised rate of healing for all Lack of generalised OrthoPak® effect may stem from an intrinsic threshold rate of stress fracture healing below which extrinsic stimuli fail to promote further affect. Under such conditions, subtle differences in healing times are very difficult to detect, and arguably clinically insignificant.

Slide 19 :

Support Department of the Army, US Army Medical Research and Materiel Command, Award Number DAMD17-98-1-8519 OrthoPak® devices supplied by BIOLECTRON, Inc. Hackensack, NJ (acquired by EBI, L.P., Parsippany, NJ)

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