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					National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

Public health evidence-based summary Electrical and electromagnetic field treatment for non-union of bones
Author: Norma Prosser, Public Health Practitioner Date: 040909 Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs Purpose and Summary of Document: This paper provides a summary of the evidence regarding treatment of electrical and electromagnetic field treatment for non-union of bones. The evidence suggests that electrical and electromagnetic treatment for the nonunion of bones has been used for a number of years in many differing forms. Its efficacy is however, still uncertain, but some studies are beginning to show some statistically significant effects. Each method of energy transfer has potential drawbacks on individual component specifications such as size, weight, tolerability, patient compliance and cost. The actual amount of energy applied to the target site may also vary with some models based on tissue depth and resistance. Bone growth response is thought to be dose-dependent, and so patient compliance is necessary. Publication/Distribution:    Publication in NPHS Health Social Care Quality Document Database Link from NPHS e-Bulletin Link from Stakeholder e-Newsletter Version: 1

 2009 National Public Health Service for Wales
Author: Norma Prosser, Public Health Practitioner Version: 1 Date: 040909 Page: 1 of 6 Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs

National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

1

Purpose

This paper provides a summary of the evidence regarding treatment of electrical and electromagnetic field treatment for non-union of bones.

2

Introduction

Most broken bones heal without problems; non-union is the failure of a broken bone to heal1. For new bone tissue to form following a fracture, bone needs adequate stability and blood supply. To stabilise the bone a cast may be required, or surgery to insert a plate, screws or nails. During the healing period blood supply to the fracture site brings the necessary oxygen, adequate nutrition: protein; calcium and vitamins C and D and the body’s own chemicals necessary to repair the break 1. Non-union occurs when the bone lacks adequate stability and/or blood flow. Other factors that may inhibit bone healing and increases the chances of a non-union include: the use of tobacco or nicotine in any form (smoke, chew, gum or patch); older age; severe anaemia; diabetes; taking some medications including antiinflammatory drugs such as aspirin and ibuprofen1. Bone growth stimulators The electrical potential in bone was first thought to be recognised in Japan in the early 1950’s2. A number of electrical and magnetic appliances have been developed in an attempt to apply the proper amount of electrical energy to bone to provide maximum healing potential. These devices may employ direct current (DC), pulsed electromagnetic fields (PEMF), combined magnetic fields (CMF), alternative currents (AC), or capacity coupling (CC) to provide electrical stimulation to a fracture site2. Varying amounts of initial energy are applied at the electrode e.g. skin pads or implanted wires to generate energy at the fracture site for maximum bone growth. The amount of energy delivered is thought to be critical, too little produces no bone reaction and too much may cause bone death and absorption. Bone stimulation is reported to enhance calcification and mineralization of the fibrocartilage repair tissue (bone growth) at the fracture site and increased vascularity2. Stimulators are commonly used for hard-to-treat factures, non-unions and poorly healing stress fractures of the scaphoid, distal tibia, femur, humerus and fifth metatarsal shaft. Implantable stimulators are also used as an adjunct to bone grafting in spinal fusion surgery2.

Author: Norma Prosser, Public Health Practitioner Version: 1

Date: 040909 Page: 2 of 6

Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs

National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

Non invasive electrical bone growth stimulators Non invasive stimulators generate a weak electric current within the target site using a variety of technologies. Some treatments require small skin pads or electrodes placed either side of the fusion site, others are delivered through treatment coils placed into a brace directly on to the skin, some deliver via a magnetic field. The application and length of time treatment is required varies according to the technique, some require 24 hour application for several months, others 30 minutes treatment per day for several months3. Non invasive bone growth stimulators are used to treat fracture non-unions in the appendicular skeleton, failed fusion after spinal fusion surgery, or as an adjunct to spinal fusion surgery to decrease the incidence of failed fusion (i.e. arthrodesis)3. Invasive electrical bone growth stimulators Invasive devices use direct current; these require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for six to nine months after implantation. The current generator is surgically removed when the treatment is completed; the electrode is not always removed3. Invasive stimulation is used as an adjunct to spinal fusion surgery to enhance the chances of obtaining a solid spinal fusion. Invasive bone growth stimulation is not used in the appendicular skeleton3.

3

Evidence summary

A meta-analysis of controlled clinical trials of the effect of electrical stimulation on musculoskeletal systems report:4 “The studies in this review had some methodological limitations, and the selected pooled trials did not constitute acceptable proof that electrical stimulation has specific effects on health”. However, the authors’ state: “That the statistically-significant positive findings reported in the trials, from which the extracted data were able to be combined, cannot be ignored”. In considering the Treatment of nonunions with electric and electromagnetic fields5 and The role of electrical stimulation in bone repair6. The authors conclude that electric and electromagnetic fields: “may be useful in clinically stimulating repair of fractures and nonunions”5 and “accelerate bone formation and repair, increase union rates in factures previously refractory to healing and produce results equivalent to bone grafts”6. One controlled trial of electrical treatment of tibia non-union concluded that there was a statistically significant positive association between tibial union and electrical stimulation7.

Author: Norma Prosser, Public Health Practitioner Version: 1

Date: 040909 Page: 3 of 6

Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs

National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

A systematic review to compare the effects of low-intensity pulsed ultrasound (LIPUS) or pulsed electromagnetic fields (PEMF) on future healing concluded that low-intensity pulsed ultrasound speeds acute fracture healing and promotes healing in non-union fractures. Evidence suggests that PEMF also increases the proportion of non-union factures that heal without additional intervention. Comparison of the effects of LIPUS and PEMF was not possible because the LIPUS controlled trial reported days to healing and the PEMF study recorded proportions of the groups with united fractures8. The use of bone growth stimulators is supported by CIGNA HealthCare9 and Aetna10 subject to criteria, conditions and indications in healthcare plans. A comprehensive assessment of the effectiveness and appropriateness of bone growth stimulators is documented in The Cigna Healthcare Coverage Position paper9.

4

Conclusion

Electrical and electromagnetic treatment for the non-union of bones has been used for a number of years in many differing forms. Its efficacy is however, still uncertain, but some studies are beginning to show some statistically significant effects. Each method of energy transfer has potential drawbacks on individual component specifications such as size, weight, tolerability, patient compliance and cost. The actual amount of energy applied to the target site may also vary with some models based on tissue depth and resistance. Bone growth response is thought to be dosedependent, and so patient compliance is necessary.

5

Review

The public health evidence summary will be reviewed in three years, or earlier, if circumstances necessitate an earlier review.

6

References
1. American Academy of Orthopaedic Surgeons [online]. Nonunions. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00374 [Accessed 1st Sep 2009] 2. Lyle CE. Stimulating treatment. Orthopedic Technology Review 2002; 4. Available at: http://www.ossatec.eu/studien/02-Stimulating-Treatment.pdf [Accessed1st Sep 2009] 3. The Regence Group. Electrical bone growth stimulations (osteogenic stimulators). Medical policy no.10. 2005. Available at: http://blue.regence.com/trgmedpol/dme/dme10.html [Accessed 1st Sep 2009]

Author: Norma Prosser, Public Health Practitioner Version: 1

Date: 040909 Page: 4 of 6

Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs

National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

4. Akai M, Hayashi K. Effect of electrical stimulation on musculoskeletal systems: a meta-analysis of controlled clinical trials. Bioelectromagnetics 2002; 23: 132-43 5. Aaron RK, Ciombr DM, Simon BJ. Treatment of nonunions with electric and electromagnetic fields. Clin Orthop Relat Res 2004; (419): 21-9 6. Ciombor DM, Aaron RK. The role of electrical stimulation in bone repair. J Foot Ankle Surg 2005; 10: 579-93

Author: Norma Prosser, Public Health Practitioner Version: 1

Date: 040909 Page: 5 of 6

Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs

National Public Health Service for Wales

Electrical and electromagnetic field treatment for non-union of bones

7. Simonis RB, Parnell EJ, Ray PS, Peacock JL. Electrical treatment of tibial non-union: a prospective, randomised, double-blind trial. The Cochrane Central Register of Controlled Trials (CENTRAL). 2008 Issue 3. Available at: http://www.mrw.interscience.wiley.com/cochrane/clcentral/articles/028/CN00437028/frame.html [Accessed 13th Mar 2009] 8. Walker NA, Denegar CR, Preische J. Low-Intensity Pulsed Ultrasound and Pulsed Electromagnetic Field in the Treatment of Tibial Fractures: A Systematic Review. Journal of Athletic Training. 2007;42(4):530–535. Available at: http://www.nata.org/jat/readers/archives/42.4/i1062-6050-424-530.pdf [Accessed 13th Mar 2009] 9. Cigna Medical Coverage Policy. Bone Growth Stimulators: Electrical (Invasive, Noninvasive), Ultrasound. Coverage Policy Number 0084. 2008. Available at: http://www.cigna.com/customer_care/healthcare_professional/coverage_p ositions/medical/mm_0084... [Accessed 28th Nov 2008] 10. Aetna. Clinical Policy Bulletins. Bone Growth Stimulators. 2005.

Author: Norma Prosser, Public Health Practitioner Version: 1

Date: 040909 Page: 6 of 6

Status: Final Intended Audience: Public (Internet) / NHS Wales (Intranet) / NPHS (Intranet) / LHBs


				
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