Electromagnetic stimulation as coadjuvant in the healing of diaphyseal femoral fractures: a randomized controlled trial (original) (raw)
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International Journal of Immunopathology and Pharmacology, 2011
Pulsed electromagnetic fields (PEMF) have been used for several years to supplement bone healing. However, the mode of action ofthis non-invasive method is still debated and quantification ofits effect on fracture healing is widely varied. At cellular and molecular level, PEMF has been advocated to promote the synthesis of extracellular matrix proteins and exert a direct effect on the production of proteins that regulate gene transcription. Electromagnetic fields may also affect several membrane receptors and stimulate osteoblasts to secrete several growth factors such as bone morphogenic proteins 2 and 4 and TGF-beta. They could also accelerate intramedullary angiogenesis and improve the load to failure and stiffness of the bone. Although healing rates have been reported in up to 87% of delayed unions and non-unions,Jhe efficacy of the method is significantly varied while patient or fracture related variables could not be clearly associated with a successful outcome.
The Journal of Bone and Joint Surgery-American Volume, 2008
This review concluded that no significant effect of electromagnetic stimulation on delayed unions or ununited longbone fractures was found, but that methodological limitations and high levels of heterogeneity between studies made the impact of electromagnetic stimulation on fracture healing uncertain. This conclusion reflects the results of the review and is likely to be reliable. Authors' objectives To assess the effectiveness of electromagnetic stimulation on long-bone fracture healing. Searching MEDLINE, EMBASE, CINAHL, and all Evidence Based Medicine Reviews were searched from inception to April 2008. Search terms were reported. Seven relevant journals were also handsearched for dates ranging from 1980 to April 2008. Bibliographies of retrieved studies and other relevant publications were checked. Study selection Randomised controlled trials (RCTs) comparing electromagnetism of any waveform with no intervention, in patients presenting with long-bone lesions, were eligible for inclusion in the review. Eligible trials had to report the effect of the interventions on direct bone healing. Interim and subset analyses of trials published in full were excluded from the review.
The Journal of Bone and …, 2011
Background: Tibial shaft fractures are sometimes complicated by delayed union and nonunion, necessitating further surgical interventions. Pulsed electromagnetic field stimulation is an effective treatment for delayed unions and nonunions, but its efficacy in preventing healing complications in patients with acute fractures is largely untested. The purpose of this pragmatic trial was to determine whether adjuvant pulsed electromagnetic field therapy for acute tibial shaft fractures reduces the rate of surgical revision because of delayed union or nonunion. Methods: In a double-blind randomized trial involving six metropolitan trauma hospitals, 259 participants with acute tibial shaft fractures (AO/OTA type 42) were randomized by means of external allocation to externally identical active and inactive pulsed electromagnetic field devices. Participants were instructed to wear the device for ten hours daily for twelve weeks. Management was otherwise unaltered. The primary outcome was the proportion of participants requiring a secondary surgical intervention because of delayed union or nonunion within twelve months after the injury. Secondary outcomes included surgical intervention for any reason, radiographic union at six months, and the Short Form-36 Physical Component Summary and Lower Extremity Functional Scales at twelve months. Main analyses were by intention to treat. Results: Two hundred and eighteen participants (84%) completed the twelve-month follow-up. One hundred and six patients were allocated to the active device group, and 112 were allocated to the placebo group. Compliance was moderate, with 6.2 hours of average daily use. Overall, sixteen patients in the active group and fifteen in the inactive group experienced a primary outcome event (risk ratio, 1.02; 95% confidence interval, 0.95 to 1.14; p = 0.72). According to perprotocol analysis, there were six primary events (12.2%) in the active, compliant group and twenty-six primary events (15.1%) in the combined placebo and active, noncompliant group (risk ratio, 0.97; 95% confidence interval, 0.86 to 1.10; p = 0.61). No between-group differences were found with regard to surgical intervention for any reason, radiographic union, or functional measures. Conclusions: Adjuvant pulsed electromagnetic field stimulation does not prevent secondary surgical interventions for delayed union or nonunion and does not improve radiographic union or patient-reported functional outcomes in patients with acute tibial shaft fractures. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence. T he tibial diaphysis is the most frequently fractured long bone and is the one that is most susceptible to delayed union and nonunion because of its precarious blood supply and minimal soft-tissue cover. Complications resulting from delayed healing often necessitate revision surgery, with resultant substantial patient morbidity and socioeconomic Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
International Journal of Applied Pharmaceutics, 2019
Objective: Under normal conditions, fractures can heal, but under some conditions, complications can occur, such as delayed union or nonunion. Interaction between the processes of angiogenesis and osteogenesis (the interaction of osteoblast and osteoclast) is the determining factor in the healing process. Exposure to an electromagnetic field, as a physical stimulus, affects osteogenesis both in the developmental stage of the embryo and in the fracture healing process. This study was conducted to determine the healing of delayed-union fractures through exposure to an extremely low-frequency-pulsed electromagnetic field (ELF-PEMF), comparing the failure load scores in experimental animals. Methods: The study was conducted in the Faculty of Medicine, Universitas Indonesia, with 56 experimental rats during August and September 2018. Results: There was a significant difference in the failure load score in both groups in the fourth and fifth weeks of the study. There were no differences in clinical improvement in the two groups. Conclusion: This study concluded that there was an improvement in delayed-union fracture healing after the administration of ELF-PEMF, as seen in the difference in failure load scores.
This study aims to design and develop the pulsed electromagnetic fields (PEMF) device which can be utilized as an adjuvant therapy in delayed union fracture. In the first stage, Arduino-based PEMF device has been built with four main modules: pulse generator, user interface, Helmholtz coil and data acquisition system. Pulse generator allowing user to operate the physical parameters: frequency, duty cycle, burst duration and exposure duration. The Helmholtz coil could produce 1.6 mT of homogenous magnetic field. In the next stage, preliminary study was done to evaluate the effect of static magnetic field (SMF) and PEMF exposure on the healing of delayed union fracture model on Spraque Dawley (SD) rats. Six SD rats were fracturized at the femoral shaft by non-union model, then they were grouped into 2 groups, 1 (n=3, SMFexposure, Bmax = 1.6 mT) and 2 (n=3, PEMF exposure, Bmax = 1.6 mT frequency = 50 Hz, duty cycle = 90%, burst cycle = 50%). Both groups had received the exposure for 4 hours per day and 7 hours per week. The evaluations of fracture healing were conducted by the histomorphometry analysis at 14, 21, and 28 days fracturization. PEMF group signal a better healing process through higher osseous tissue area.
Pulsed electromagnetic field treatments enhance the healing of fibular osteotomies
Journal of Orthopaedic Research, 2005
This study tested the hypothesis that pulsed electromagnetic field (PEMF) treatments augment and accelerate the healing of bone trauma. It utilized micro-computed tomography imaging of live rats that had received bilateral 0.2 mm fibular osteotomies (-0.5% acute bone loss) as a means to assess the in vivo rate dynamics of hard callus formation and overall callus volume. Starting 5 days post-surgery, osteotomized right hind limbs were exposed 3 h daily to Physio-Stim@ PEMF, 7 days a week for up to 5 weeks of treatment. The contralateral hind limbs served as sham-treated, within-animal internal controls. Although both PEMF-and sham-treatment groups exhibited similar onset of hard callus at -9days after surgery, a 2-fold faster rate of hard callus formation was observed thereafter in PEMF-treated limbs, yielding a 2-fold increase in callus volume by 13-20 days after surgery. The quantity of the new woven bone tissue within the osteotomy sites was significantly better in PEMF-treated versus sham-treated fibulae as assessed via hard tissue histology. The apparent modulus of each callus was assessed via a cantilever bend test and indicated a 2-fold increase in callus stiffness in the PEMF-treated over sham-treated fibulae. PEMF-treated fibulae exhibited an apparent modulus at the end of 5-weeks that was -80% that of unoperated fibulae. Overall, these data indicate that Physio-Stim@ PEMF treatment improved osteotomy repair. These beneficial effects on bone healing were not observed when a different PEMF waveform, Osteo-Stim@, was used. This latter observation demonstrates the specificity in the relationship between waveform characteristics and biological outcomes.
Bioelectromagnetics, 2014
Delayed bone healing has been noted in osteoporosis patients and in the ovariectomized (OVX) rat model of estrogen-depletion osteopenia. Pulsed electromagnetic field (PEMF) devices are clinically approved as an adjunct to cervical fusion surgery in patients at high risk for non-fusion and for the treatment of fracture non-unions. These bone growth stimulating devices also accelerate the healing of fresh fracture repair in skeletally mature normal rats but have not been tested for efficacy to accelerate and/or enhance the delayed bone repair process in OVX rats. The current study tested the hypothesis that daily PEMF treatments would improve the fracture healing response in skeletally mature OVX rats. By 6 weeks of healing, PEMF treatments resulted in improved hard callus elastic modulus across fibula fractures normalizing the healing process in OVX rats with respect to this mechanical property. Radiographic evidence showed an improved hard callus bridging across fibula fractures in OVX rats treated with PEMF as compared to sham treatments. These findings provide a scientific rationale for investigating whether PEMF might improve bone-healing responses in at-risk osteoporotic patients.
Pulsed electromagnetic fields for the treatment of bone fractures
Bangladesh Medical Research Council Bulletin
The effectiveness of electrical stimulation and Pulsed Electro Magnetic Field (PEMF) stimulation for enhancement of bone healing has been reported by many workers. The mechanism of osteogenesis is not clear, therefore, studies look for empirical evidence. The present study involved a clinical trial using low amplitude PEMF on 19 patients with non-union or delayed union of the long bones. The pulse system used was similar in shape to Bassett's single pulse system where the electric voltage pulse was 0.3 mSec wide repeating every 12 mSec making a frequency of about 80 Hz. The peak magnetic fields were of the order of 0.01 to 0.1 m Tesla, hundred to thousand times smaller than that of Bassett. Among the 13 who completed this treatment schedule the history of non-union was an average of 41.3 weeks. Within an average treatment period of 14 weeks, 11 of the 13 patients had successful bone healing. The two unsuccessful cases had bone gaps greater than 1 cm following removal of dead bon...
Orthopedic Research and Reviews, 2016
During normal fracture repair, healing occurs within a few months. However, for a minority of patients, the processes of bone repair are compromised or interrupted leading to the development of delayed union and nonunion fractures. Noninvasive bone growth stimulators using pulsed electromagnetic field (PEMF) technology are currently in widespread use by patients with impaired fracture healing. This article reports the results of a follow-up study of 1,382 patients treated with PEMF stimulation to evaluate success rates and the relationship between average daily use and the clinical outcomes of therapy as reported by their prescribing physicians. The reported overall success rate for the 1,382 patients was 89.6%. The results were analyzed in audited subsets comparing days of treatment time and average daily use of the electrical bone growth stimulator, using several statistical methods. Linear regression analysis indicated a 6-day reduction in time to heal with each additional hour of average daily use. Survival analysis concluded that the median heal time was reduced by 35%-60%, depending on the different fracture characteristics of patients who complied with the recommended daily use of 10 hours per day. A third statistical analysis indicated that patients treated with the PEMF device for 9 hours or more per day had a significant reduction in time to heal, achieving successful fracture repair an average of 76 days earlier than patients treated with the PEMF device for an average of 3 hours or less per day. Overall, these different methods of statistical analysis indicate that PEMF therapy correlates with an acceleration in the healing of nonunion fractures.
Effects of local vibration and pulsed electromagnetic field on bone fracture: A comparative study
Bioelectromagnetics, 2017
The effectiveness of various therapeutic methods on bone fracture has been demonstrated in several studies. In the present study, we tried to evaluate the effect of local low-magnitude, high-frequency vibration (LMHFV) on rat tibia fracture in comparison with pulsed electromagnetic fields (PEMF) during the healing process. Mid-diaphysis tibiae fractures were induced in 30 Sprague-Dawley rats. The rats were assigned into groups such as control (CONT), LMHFV (15 min/day, 7 days/week), and PEMF (3.5 h/day, 7 days/week) for a three-week treatment. Nothing was applied to control group. Radiographs, serum osteocalcin levels, and stereological bone analyses of the three groups were compared. The X-rays of tibiae were taken 21 days after the end of the healing process. PEMF and LMHFV groups had more callus formation when compared to CONT group; however, the difference was not statistically significant (P = 0.375). Serum osteocalcin levels were elevated in the experimental groups compared to...