Spine J. 2008 May-Jun;8(3):436-42. Epub 2007 Jul 17.

Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion.

Foley KT, Mroz TE, Arnold PM, Chandler HC Jr, Dixon RA, Girasole GJ, Renkens KL Jr, Riew KD, Sasso RC, Smith RC, Tung H, Wecht DA, Whiting DM.

Department of Neurosurgery, University of Tennessee Health Science Center and Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee 38104, USA. kfoley@usit.net

Abstract

BACKGROUND CONTEXT: Multilevel fusions, the use of allograft bone, and smoking have been associated with an increased risk of nonunion after anterior cervical discectomy and fusion (ACDF) procedures. Pulsed electromagnetic field (PEMF) stimulation has been shown to increase arthrodesis rates after lumbar spine fusion surgery, but there are minimal data concerning the effect of PEMF stimulation on cervical spine fusion.

PURPOSE: To determine the efficacy and safety of PEMF stimulation as an adjunct to arthrodesis after ACDF in patients with potential risk factors for nonunion.

STUDY DESIGN: A randomized, controlled, prospective multicenter clinical trial.

PATIENT SAMPLE: Three hundred and twenty-three patients with radiographic evidence (computed tomography-myelogram [CT-myelo] or magnetic resonance imaging [MRI]) of a compressed cervical nerve root and symptomatic radiculopathy appropriate to the compressed root that had failed to respond to nonoperative management were enrolled in the study. The patients were either smokers (more than one pack per day) and/or were undergoing multilevel fusions. All patients underwent ACDF using the Smith-Robinson technique. Allograft bone and an anterior cervical plate were used in all cases.

OUTCOME MEASURES: Measurements were obtained preoperatively and at each postoperative interval and included neurologic assessment, visual analog scale (VAS) scores for shoulder/arm pain at rest and with activity, SF-12 scores, the neck disability index (NDI), and radiographs (anteroposterior, lateral, and flexion-extension views). Two orthopedic surgeons not otherwise affiliated with the study and blinded to treatment group evaluated the radiographs, as did a blinded radiologist. Adverse events were reported by all patients throughout the study to determine device safety.

METHODS: Patients were randomly assigned to one of two groups: those receiving PEMF stimulation after surgery (PEMF group, 163 patients) and those not receiving PEMF stimulation (control group, 160 patients). Postoperative care was otherwise identical. Follow-up was carried out at 1, 2, 3, 6, and 12 months postoperatively.

RESULTS: The PEMF and control groups were comparable with regard to age, gender, race, past medical history, smoking status, and litigation status. Both groups were also comparable in terms of baseline diagnosis (herniated disc, spondylosis, or both) and number of levels operated (one, two, three, or four). At 6 months postoperatively, the PEMF group had a significantly higher fusion rate than the control group (83.6% vs. 68.6%, p=.0065). At 12 months after surgery, the stimulated group had a fusion rate of 92.8% compared with 86.7% for the control group (p=.1129). There were no significant differences between the PEMF and control groups with regard to VAS pain scores, NDI, or SF-12 scores at 6 or 12 months. No significant differences were found in the incidence of adverse events in the groups.

CONCLUSIONS: This is the first randomized, controlled trial that analyzes the effects of PEMF stimulation on cervical spine fusion. PEMF stimulation significantly improved the fusion rate at 6 months postoperatively in patients undergoing ACDF with an allograft and an anterior cervical plate, the eligibility criteria being patients who were smokers or had undergone multilevel cervical fusion. At 12 months postoperatively, however, the fusion rate for PEMF patients was not significantly different from that of the control group. There were no differences in the incidence of adverse events in the two groups, indicating that the use of PEMF stimulation is safe in this clinical setting.

Ann Biomed Eng. 2008 Feb;36(2):195-203. Epub 2007 Nov 27.

Why do electromagnetic pulses enhance bone growth?

Bowen SP, Mancini JD, Fessatidis V, Grabiner M.

Department of Chemistry and Physics, Chicago State University, Chicago, IL 60628, USA. sbowen@csu.edu

Abstract

The excitation probability of substrate molecules involved in the production of growth factors influencing the division of chondrocytes in the growth layer of bone under the influence of pulsed electromagnetic fields is studied theoretically in a quantum mechanical model calculation. In this model matrix elements and anti-bonding energy levels are assumed known and the dynamics of the interaction with pulsed electromagnetic fields is derived. The derivation makes it clear that continuous pulsing or large driving currents can overwhelm local diffusive transport to the growth plane resulting in a loss of its enhancement properties. Optimal locations within a pair of Helmholtz coils for enhancement of bone growth are also investigated and found to be close to the coils. The work presented here is believed to be the first derivation in a model calculation of a physical basis for the effects of pulsed electromagnetic fields on bone growth and fusion.

outh Med J. 2004 May;97(5):519-24.

Reversal of delayed union of anterior cervical fusion treated with pulsed electromagnetic field stimulation: case report.

Mackenzie D, Veninga FD.

Department of Surgery, Medical Center of Plano, Plano, TX, USA.

Abstract

We present a case report of anterior cervical fusion non-union that was successfully treated with pulsed electromagnetic field (PEMF) stimulation. In this case, a C6-C7 nonunion was identified clinically and radiographically 1 year after surgery. Imaging revealed nonunion with partial resorption of the bone graft compared with imaging studies performed 8 months earlier. The patient wore a PEMF stimulation device for 3 h/d for 10 months. After 3 months of treatment, the patient’s symptoms were resolved. X-rays obtained after 15 weeks of stimulation showed improvement in bone fusion, and x-rays obtained at 31 weeks after stimulation showed even bone density around the C7 screws. The patient remained symptom-free 13 months after the termination of PEMF stimulation at last assessment. PEMF stimulation demonstrated its clinical potential in healing established nonunion of anterior cervical spine fusion. Its use is noninvasive and can be considered an alternative to surgical intervention in selected patients.

Am J Orthop (Belle Mead NJ). 2004 Jan;33(1):27-30.

Pseudarthrosis after lumbar spine fusion: nonoperative salvage with pulsed electromagnetic fields.

Simmons JW Jr, Mooney V, Thacker I.

UTMB, Galveston, Texas, USA.

Abstract

We studied 100 patients in whom symptomatic pseudarthrosis had been established at more than 9 months after lumbar spine fusion. All patients were treated with a pulsed electromagnetic field device worn consistently 2 hours a day for at least 90 days. Solid fusion was achieved in 67% of patients. Effectiveness was not statistically significantly different for patients with risk factors such as smoking, use of allograft, absence of fixation, or multilevel fusions. Treatment was equally effective for posterolateral fusions (66%) as with interbody fusions (69%). For patients with symptomatic pseudarthrosis after lumbar spine fusion, pulsed electromagnetic field stimulation is an effective nonoperative salvage approach to achieving fusion.

J Am Acad Orthop Surg. 2003 Sep-Oct;11(5):344-54.

Use of physical forces in bone healing.

Nelson FR, Brighton CT, Ryaby J, Simon BJ, Nielson JH, Lorich DG, Bolander M, Seelig J.

Henry Ford Hospital, Detroit, MI, USA.

Abstract

During the past two decades, a number of physical modalities have been approved for the management of nonunions and delayed unions. Implantable direct current stimulation is effective in managing established nonunions of the extremities and as an adjuvant in achieving spinal fusion. Pulsed electromagnetic fields and capacitive coupling induce fields through the soft tissue, resulting in low-magnitude voltage and currents at the fracture site. Pulsed electromagnetic fields may be as effective as surgery in managing extremity nonunions. Capacitive coupling appears to be effective both in extremity nonunions and lumbar fusions. Low-intensity ultrasound has been used to speed normal fracture healing and manage delayed unions. It has recently been approved for the management of nonunions. Despite the different mechanisms for stimulating bone healing, all signals result in increased intracellular calcium, thereby leading to bone formation.

Adv Ther. 2001 Jan-Feb;18(1):12-20.

Outcomes after posterolateral lumbar fusion with instrumentation in patients treated with adjunctive pulsed electromagnetic field stimulation.

Bose B.

Medical Center of Delaware, Newark, USA.

Abstract

Fusion success and clinical outcome were determined in 48 high-risk patients who underwent posterolateral lumbar fusions with internal fixation and were treated with adjunctive pulsed electromagnetic field (PEMF) stimulation postoperatively. An independent radiographic assessment demonstrated a success rate of 97.9%. Following treatment, 59% of the working patients returned to their employment. Overall clinical assessment was excellent in 4.2% of patients, good in 79.2%, and fair in 16.7%; no patient had a poor clinical assessment.

J Spinal Disord. 2000 Aug;13(4):290-6.

Prospective comparison of the effect of direct current electrical stimulation and pulsed electromagnetic fields on instrumented posterolateral lumbar arthrodesis.

Jenis LG, An HS, Stein R, Young B.

New England Baptist Spine Center, Boston, Massachusetts 02120, USA.

Abstract

The purpose of this prospective study was to compare the effect of adjunctive direct current (DC) electrical stimulation and pulsed electromagnetic field therapy (PEMF) on augmentation of instrumented lumbar fusion. Sixty-one patients undergoing lumbar spine fusion were enrolled in the study and randomized to one of three treatment protocols: 1) adjunctive PEMF group (n = 22) fitted with Spinal-Stim model 8212(AME) within 30 days of surgery; 2) DC group (n = 17) had a SpF-2T stimulator(EBI) implanted at the time of surgery; or 3) control group (n = 22). The fusion mass bone mineral density (BMD) assessment was performed on 3-month and 1-year radiographs for each patient. Lateral flexion-extension and anteroposterior radiographs were evaluated at 1 year to determine the presence of fusion. Clinical outcome patient analyses were performed at 1 year. At 1-year follow-up, radiographic fusion and fusion mass bone density were not significantly different among the groups. In the nonstimulated group, there were 43% excellent, 43% good, and 14% fair results. In the PEMF group, there were 35% excellent, 50% good, 10% fair, and 5% poor results. In the DC group, there were 32% excellent, 37% good, and 31% fair results. The results of the current study suggest that electrical stimulation does not significantly enhance fusion rate in instrumented lumbar arthrodesis, although we observed a statistically insignificant trend toward increased fusion mass BMD in the electrically stimulated groups. The significance of increased BMD remains unknown.

Adv Ther. 2000 Mar-Apr;17(2):57-67.

Spine fusion for discogenic low back pain: outcomes in patients treated with or without pulsed electromagnetic field stimulation.

Marks RA.

Richardson Orthopaedic Surgery, Texas 75080, USA.

Abstract

Sixty-one randomly selected patients who underwent lumbar fusion surgeries for discogenic low back pain between 1987 and 1994 were retrospectively studied. All patients had failed to respond to preoperative conservative treatments. Forty-two patients received adjunctive therapy with pulsed electromagnetic field (PEMF) stimulation, and 19 patients received no electrical stimulation of any kind. Average follow-up time was 15.6 months postoperatively. Fusion succeeded in 97.6% of the PEMF group and in 52.6% of the unstimulated group (P < .001). The observed agreement between clinical and radiographic outcome was 75%. The use of PEMF stimulation enhances bony bridging in lumbar spinal fusions. Successful fusion underlies a good clinical outcome in patients with discogenic low back pain.

Spine (Phila Pa 1976). 1997 Oct 15;22(20):2351-6.

Use of electromagnetic fields in a spinal fusion. A rabbit model.

Glazer PA, Heilmann MR, Lotz JC, Bradford DS.

Department of Orthopaedic Surgery, University of California, San Francisco, USA.

Abstract

STUDY DESIGN: The biomechanical and histologic characteristics of posterolateral spinal fusion in a rabbit model with and without the application of a pulsed electromagnetic field were analyzed in a prospective, randomized trial. In addition, fusion rate with and without a pulsed electromagnetic field in this model was assessed by biomechanical testing, radiographs, and manual palpation.

OBJECTIVES: To evaluate the influence of a pulsed electromagnetic field on the spinal fusion rate and biomechanical characteristics in a rabbit model.

SUMMARY OF BACKGROUND DATA: Previous studies performed to assess the benefits of a pulsed electromagnetic field in spinal fusion have been complicated by the use of instrumentation, and the animal models used do not have a pseudarthrosis rate comparable to that seen in humans. In contrast, the posterolateral intertransverse process fusion in the rabbit is uncomplicated by the use of instrumentation and has been shown to have a pseudarthrosis rate similar to that found in humans (5-35%).

METHODS: Ten New Zealand white rabbits each were randomly assigned to undergo spinal fusion using either 1) autologous bone with electromagnetic fields, or 2) autologous bone without electromagnetic fields. A specially designed plastic constraint was used to focus the pulsed electromagnetic field over the rabbits’ lumbar spine 4 hours per day. Animals were killed at 6 weeks for biomechanical and histologic testing.

RESULTS: The rate of pseudarthrosis, as evaluated radiographically and manually in a blinded fashion, decreased from 40% to 20% with the pulsed electromagnetic field, but this decrease in the nonunion rate was not statistically significant given the number of animals per group. Biomechanical analysis of the fusion mass showed that a pulsed electromagnetic field resulted in statistically significant increases in stiffness (35%), area under the load-displacement curve (37%), and load to failure of the fusion mass (42%). Qualitative histologic assessment showed increased bone formation in those fusions exposed to a pulsed electromagnetic field.

CONCLUSIONS: This study demonstrates the reproducibility of a rabbit fusion model, and the ability of a pulsed electromagnetic field to induce a statistically significant increase in stiffness, area under the load-displacement curve, and load to failure of the fusion mass. This investigation provides a basis for continued evaluation of biologic enhancement of spinal arthrodesis with the use of a pulsed electromagnetic field.

Spine (Phila Pa 1976). 1997 Feb 15;22(4):382-8.

The effect of pulsed electromagnetic fields on instrumented posterolateral spinal fusion and device-related stress shielding.

Ito M, Fay LA, Ito Y, Yuan MR, Edwards WT, Yuan HA.

Department of Orthopaedics, Hokkaido University School of Medicine, Sapporo, Japan.

Abstract

STUDY DESIGN: This study was designed to examine stress-shielding effects on the spine caused by rigid implants and to investigate the effects of pulsed electromagnetic fields on the instrumented spine.

OBJECTIVES: To investigate the effects of pulsed electromagnetic fields on posterolateral spinal fusion, and to determine if osteopenia induced by rigid instrumentation can be diminished by pulsed electromagnetic fields.

SUMMARY OF BACKGROUND DATA: Although device-related osteopenia on vertebral bodies is of a great clinical importance, no method for preventing bone mineral loss in vertebrae by stiff spinal implants has been effective.

METHODS: Twenty-eight adult beagles underwent L5-L6 destabilization followed by posterolateral spinal fusion. The study was divided into four groups: 1) Group CNTL: without instrumentation, without pulsed electromagnetic fields, 2) Group PEMF: without Steffee, with pulsed electromagnetic fields, 3) Group INST: with Steffee, without pulsed electromagnetic fields, 4) Group PEMF + INST: with Steffee, with pulsed electromagnetic fields. At the end of 24 weeks, the dogs were killed, and L4-L7 segments were tested biomechanically without instrumentation. Radiographs and quantitative computed tomography assessed the condition of the fusion mass.

RESULTS: Stress shielding was induced in the anterior vertebral bodies of L6 with the Steffee plates; bone mineral density was increased with the addition of pulsed electromagnetic fields, regardless of the presence or absence of fixation. A decrease in flexion and bending stiffness was observed in the Group INST; pulsed electromagnetic fields did increase the flexion stiffness regardless of the presence or absence of fixation, although this was not statistically significant.

CONCLUSIONS: Use of pulsed electromagnetic fields has the potential to minimize device-related vertebral-bone mineral loss.

Spine (Phila Pa 1976). 1994 Mar 15;19(6):705-9.

The effect of electromagnetic pulsing on posterior lumbar spinal fusions in dogs.

Kahanovitz N, Arnoczky SP, Nemzek J, Shores A.

Anderson Clinic, Arlington, Virginia.

Abstract

This study evaluated the effect of pulsed electromagnetic fields (PEMF) on the healing of lumbar spinal fusions. Bilateral posterior facet fusions were performed at L1-2 and L4-5 in 24 adult mongrel dogs. After surgery, eight animals were stimulated with a pulse burst type signal (PEMF) for 30 minutes a day, and eight animals were stimulated with the same PEMF for 60 minutes a day. The remaining eight animals received no active PEMF stimulation and served as controls. Four animals from each group were euthanatized at 6 and 12 weeks, and the facet fusions were evaluated using high resolution radiographs and routine histology. No statistical difference in the radiographic or histologic appearance of the fusion mass could be detected between the stimulated and control groups at either 6 or 12 weeks. The results of this study suggest that PEMF stimulation had no effect on the healing of the primary posterior spinal fusions in this controlled experimental canine model.

Spine (Phila Pa 1976). 1990 Jul;15(7):708-12.

A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions.

Mooney V.

Division of Orthopaedic Surgery, University of California, Irvine.

Abstract

A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

J Bone Miner Res. 1989 Apr;4(2):227-33.

Stimulation of experimental endochondral ossification by low-energy pulsing electromagnetic fields.

Aaron RK, Ciombor DM, Jolly G.

Department of Biochemistry and Biophysics, University of Rhode Island, Providence.

Abstract

Pulsed electromagnetic fields (PEMFs) of certain configuration have been shown to be effective clinically in promoting the healing of fracture nonunions and are believed to enhance calcification of extracellular matrix. In vitro studies have suggested that PEMFs may also have the effect of modifying the extracellular matrix by promoting the synthesis of matrix molecules. This study examines the effect of one PEMF upon the extracellular matrix and calcification of endochondral ossification in vivo. The synthesis of cartilage molecules is enhanced by PEMF, and subsequent endochondral calcification is stimulated. Histomorphometric studies indicate that the maturation of bone trabeculae is also promoted by PEMF stimulation. These results indicate that a specific PEMF can change the composition of cartilage extracellular matrix in vivo and raises the possibility that the effects on other processes of endochondral ossification (e.g., fracture healing and growth plates) may occur through a similar mechanism.

Orthop Clin North Am. 1984 Jan;15(1):61-87.

The development and application of pulsed electromagnetic fields (PEMFs) for ununited fractures and arthrodeses.

Bassett CA.

Abstract

This article deals with the rational and practical use of surgically noninvasive pulsed electromagnetic fields (PEMFs) in treating ununited fractures, failed arthrodeses, and congenital pseudarthroses (infantile nonunions). The method is highly effective (more than 90 per cent success) in adult patients when used in conjunction with good management techniques that are founded on biomechanical principles. When union fails to occur with PEMFs alone after approximately four months, their proper use in conjunction with fresh bone grafts insures a maximum failure rate of 1 to 1.5 per cent. Union occurs because the weak electric currents induced in tissues by the time-varying fields effect calcification of the fibrocartilage in the fracture gap, thereby setting the stage for the final phases of fracture healing by endochondral ossification. The efficacy, safety, and simplicity of the method has prompted its use by the majority of orthopedic surgeons in this country. In patients with delayed union three to four months postfracture, PEMFs appear to be more successful and healing, generally, is more rapid than in patients managed by other conservative methods. For more challenging problems such as actively infected nonunions, multiple surgical failures, long-standing (for example, more than two years postfracture) atrophic lesions, failed knee arthrodeses after removal of infected prostheses, and congenital pseudarthroses, success can be expected in a large majority of patients in whom PEMFs are used. Finally, as laboratory studies have expanded knowledge of the mechanisms of PEMF action, it is clear that different pulses affect different biologic processes in different ways. Selection of the proper pulse for a given pathologic entity has begun to be governed by rational processes similar, in certain respects, to those applied to pharmacologic agents.