Public health evidence-based summary

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National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
1

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs



P
ublic
health e
vidence
-
based
s
ummary

E
lectrical and
e
lectromagnetic
f
ield
t
reatment for
n
on
-
union of
b
ones

Author:

Norma Prosser, Public Health Practitioner

Date:

0409
09


Version:

1

Status
:

Final

Intended Audience
:

Public

(Internet)

/ NHS Wales
(Intr
anet)
/ NPHS
(Intranet)

/
LHBs

Purpose and
Summary

of Document
:

This paper provides a summary of the evidence regard
ing

t
reatment
of
electrical and
electromagnetic field treatment for non
-
union of bones
.


The evidence suggests that
e
lectrical and electrom
agnetic 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 transfe
r 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. Bo
ne 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





2009

National Public Health Service for Wales

National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
2

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs



1

Purpose

This paper
provides a summary
of the

evidence regarding
t
reatment
of
electrical and
electromagnetic field treatment for non
-
union of bones
.

2

Introduction

M
ost broken bones heal without
problems
;

n
on
-
union
is the failure of a broken bone
to hea
l
1
.

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 nail
s
.

During the healing per
iod blood supply to the
fracture site
brings the necessary
o
xygen,
adequate nutrition
:

protein
;

calcium and vitamins C and
D

and the body’s own chemicals necessary to repair the break
1
.

Non
-
union

occur
s

when the bone lacks adequate stability and/or blood f
low. 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 anti
-
inflammat
ory drugs such as aspirin and ibuprofen
1
.

B
one growth stimulators

The electrical potential in bone was first thought to be recognised in Japan in the
early 1950’s
2
.

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) t
o provide electrical stimulation to a fracture site
2
.

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 though
t 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 inc
reased vascularity
2
.

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 b
one grafting
in spinal fusion surgery
2
.



National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
3

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs


N
on 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 electrode
s

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 months
3
.

Non invasive bone growth stimulators are used to treat fracture non
-
unions in the
ap
p
endicular skeleton, failed fusion after spinal fusion surg
ery, or as an adjunct to
spinal fusion surgery to decrease the incidence of failed fusion (i.e. arthrodesis)
3
.

I
nvasive 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 removed
3
.

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 th
e appendicular skeleton
3
.

3

Evidence s
ummary

A meta
-
analysis of controlled clinical trials

of th
e

e
ffect of electrical stimula
tion on
musculoskeletal systems

report
:
4



The studies in this review had some methodological limitations, and the selected
pooled t
rials 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 t
he
Treatment of nonunions with electric and electromagnetic fields
5

and
The role of electrical stimulation in bone repair
6
.

The authors conclude that
electric and electromagnetic fields
:


may be useful in clin
ically 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 treatme
nt of tibia non
-
union

concluded that there was
a statistically significant positive association between tibial union and electrical
stimulation
7
.

National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
4

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs


A systematic review to compare the effects of low
-
intensity pulsed ultrasound
(LIPUS) or pulsed electromagnet
ic 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 a
dditional intervention.
Comparison of the effects
of LIPUS and P
EMF was not possible because the LIPUS controlled trial reported
days to healing and the PEMF study recorded proportions of the groups with united
fractures
8
.


T
he use of
bone growth stimulato
rs is supported by CIGNA HealthCare
9

and Aetna
10

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 Cover
age Position paper
9
.

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 statist
ically 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.

5

Re
view

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


6

References

1.

American Academy
of Orthopaedic Surgeons

[online].

Nonunions.

Available at:
http://orthoinfo.aaos.org/topic.cfm?topic=A00374

[Accessed
1
st

Sep 2009]

2.

Lyle C
E. Stimulating
t
reatment.
Orthopedic
Technology

Review

2002; 4.
Available at:
http://www.ossatec.eu/studien/02
-
Stimulating
-
Treatment.pdf



[Accessed1
st

Sep 2009]

3.

The
Regence

Group.

Electrical bone growth stimulations (osteogenic
s
timulators).

Medical policy no.10.
2005.

Available at:
http://blue.regence.com/trgmedpol/dme/dme10.html

[Accessed 1
st
Sep
2009]

National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
5

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs


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

National Public Health Service for Wales

E
lectrical and electromagne
tic field treatment for
non
-
union of bones


Author: Norma Prosser, Public Health
Practit
ioner

Date: 0409
09

Status: Final

Version: 1

Page:
6

of
6

Intended Audience: Public
(Internet) / NHS Wales (Intranet) /
NPHS (In
tranet) / LHBs


7.

Simonis RB, Parnell EJ, Ray PS, Peacock JL
.
Electrical treatment of tibial
non
-
union: a prospective, rand
omised, double
-
blind trial.
The Cochrane
Central Register of Controlled Trials (CENTRAL)
.

2008 Issue 3
. Available
at:

http://www.mrw.interscience.w
iley.com/cochrane/clcentral/articles/028/CN
-
00437028/frame.html

[Accessed 13
th

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
-
42
-
4
-
530.pdf

[Accessed 13
th

Mar 2009]

9.

Cigna Medical Cov
erage 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...

[Acce
ssed 28th Nov 2008]

10.

Aetna. Clinical Policy Bulletins.
Bone Growth Stimulators
. 2005.