622 Neurology India | Sep-Oct 2009 | Vol 57 | Issue 5
Original Article
Efcacy of pulsed electromagnetic eld
therapy in healing of pressure ulcers:
A randomized control trial
Anupam Gupta, Arun B. Taly
1
, Abhishek Srivastava, Sendhil Kumar, Murali Thyloth
Department of Psychiatric & Neurological Rehabilitation,
1
Neurology, National Institute of Mental Health & Neuro Sciences
(NIMHANS), Bangalore, India
Introduction
Pressure ulcers are one of the most common complications
in health care settings and the reported incidence varied
between 8.5 and 23.9%
[1,2]
and the prevalence between
4 and 49%,
[3-9]
depending on the clinical setting. Stage I
ulcers are the most common accounting for 48% of the
overall prevalence.
[3]
The most common sites are sacrum
and heel.
[3,6,8]
Apart from risk factors in the Braden’s scale,
overweight and extreme ages are also signicant factors
in acute care setting.
[1,3]
Abstract
Background: Pressure ulcers are one of the most common complications in health care
settings. Still there are no optimal protocols to manage the pressure ulcers. Aim: To assess
the effectiveness of pulsed electromagnetic field therapy (PEMF) in healing of pressure
ulcers in patients with neurological disorders. Design: Randomized double blind control
trial. Setting: Neurological rehabilitation department in a university research hospital.
Participants: Twelve patients (M:F, 9:3) having neurological disorders, with age between
12-50 years (mean 30.16611.32 yrs) and 24 pressure ulcers. Intervention: Six patients
with 13 ulcers received PEMF therapy and the remaining 6 patients with 11 ulcers received
sham treatment, for 30 sessions (45 minutes each) using the equipment ‘Pulsatron’.
The frequency of PEMF was set at 1 Hz with sine waves and current intensity of 30 mili
ampere. Whole body exposure was given in both the groups. Outcome Measures: Bates-
Jensen wound assessment tool (BJWAT) score was used as main outcome measure and
scores at the end of session were compared with initial scores and analyzed. Similarly
National Pressure Ulcer Advisory Panel (NPUAP) scores were compared and analyzed
as secondary outcome measure. Results: Thirteen ulcers were in stage IV and 11 were
in stage III at the start of the study. Significant healing of ulcers was noted, BJWAT
scores, in both the treatment and sham groups (
P
, 0.001 and 0.003 respectively)
at the completion of the study. However, when comparing between the groups, healing
was not significant (
P
5 0.361). Similarly trend was noted with NPUAP scores with
no significant difference between the treatment and sham groups (
P
5 0.649) at the
completion of study. Conclusions: No significant difference in pressure ulcer healing was
observed between PEMF treatment and sham group in this study.
Key words: Neurological illness, pulsed electromagnetic field, pressure ulcers
Common physical modalities used to manage pressure
ulcers reduce soft tissue inflammation, improve
circulation, increase soft tissue extensibility and remodel
the scar tissue.
[10]
There has been increasing interest in
the electromagnetic eld in the management of ischemic
and venous ulcers. It is hypothesized that electrical
stimulation influences the migratory, proliferative
and synthetic functions of broblasts, and also results
in increased expression of growth factors.
[11]
Sheffet
et al.,
[12]
suggested the use of moist wound dressing and
electrotherapy as adjuvant therapy in the management
Address for correspondence:
Dr. Anupam Gupta,
Department of Psychiatric &
Neurological Rehabilitation,
National Institute of Mental Health
& Neuro Sciences (NIMHANS)
Bangalore - 560 029,
Karnataka, India.
E-mail: anupam@nimhans.kar.nic.in
PMID: 19934563
DOI: 10.4103/0028-3886.57820
623Neurology India | Sep-Oct 2009 | Vol 57 | Issue 5
Gupta, et al.: Pulsed magnetic eld therapy in pressure ulcers
of stage III, IV, and recalcitrant stage II ulcers. Pulsed
electromagnetic field (PEMF) therapy is a distinct
from electrotherapy. It induces a eld effect, not a direct
electric effect on the ulcer.
[13]
PEMF are usually low
frequency elds with very specic shape and amplitude
and do not exhibit the complications of contact of
electrodes. Further, they can be applied in the presence
of a cast or wound dressing and the risk of infection
is signicantly low.
[14-16]
Therapeutic efcacy of PEMF
therapy depends on a number of factors, such as age,
general health and gender as well as on the stage of
pathology/disease.
[14,15]
PEMF therapy has been tried in
the treatment of stage II and III pressure ulcers in two
trials.
[17,18]
A systematic review has suggested the need
for more trails in this area.
[19]
This randomized control
study assessed the efcacy of PEMF therapy stage III or
stage IV pressure ulcers in patients with neurological
diseases.
Materials and Methods
This randomized double blind control trial was carried
out over a period of six months (July 2006 to December
2006) and included 12 inpatients with neurological
disorders having one or more stage III or IV clean and
non-infected ulcers (NPUAP, 1989).
[20]
Pressure ulcers
with escher, slough, or infection were debrided, and
adequately treated with local and/or systemic antibiotics
before recruitment in the study. Patients with cardiac
pacemakers and pregnant women were excluded
from the study. Nonischemic ulcers and ulcers with
underlying osteomyelitis were also excluded from the
study. The study had the approval of the Institutional
Ethics Committee. After obtaining informed consent,
patients were randomly assigned into Group I (treatment
group) and Group II (sham group). The sequence for
random assignment of the patients was generated
by table of random numbers. Six patients (13 ulcers)
in group I received PEMF therapy and six patients
(11 ulcers) in group II received sham therapy. The end
points of the study were: ulcer healing, or completion
of 30 sessions after entry into the study, whichever was
early. Bates-Jensen wound assessment tool (BJWAT)
score was used as main outcome measure and scores at
the end of session were compared with initial scores and
analyzed. Similarly National Pressure Ulcer Advisory
Panel (NPUAP) scores were compared and analyzed as
secondary outcome measure
Both groups were given standard pressure ulcer
care, practiced in the center. Pressure ulcers in both
the groups received daily dressing with normal saline
from day one of the study. Patients were blinded about
their group assignment (PEMF or sham therapy). All
patients were made to lay on a couch, which is a part
of the ‘Pulsatron’ equipment (Madras Institute of
Magnetobiology, Chennai, India) [Figure 1 and Table 1].
The couch is encircled by a metallic frame. Homogenous
pulsating electromagnetic eld is generated in the frame,
covering the whole space within the frame (including
the patients). The equipment provides a low intensity
and ultra low frequency homogenous magnetic eld.
The patient lies comfortably in supine or prone position.
Patients in Group I (treatment group) received 1 Hz
frequency sine waves with 30 mili ampere current
intensity. Dressing over the pressure ulcers were not
removed during the therapy sessions. Patients were
exposed to PEMF for 30 sessions, each of 45-min
duration. Therapy was given for ve days a week till
the end points of the study. For patients in Group II (the
sham group) similar protocol was followed but PEMF
equipment was not switched-on.
The wound healing was assessed by Bates Jensen
Wound Assessment Tool (BJWAT)
[21]
and ulcer
staging by National Pressure Ulcer Advisory Panel
(NPUAP) protocol.
[20]
BJWAT gives pressure ulcers
a score from 13 to 60 with lower score indicating a
better status or regenerating wound and higher score
indicating wound deterioration or degeneration on a
wound status continuum. There are four ulcer stages
in NPUAP staging: stage I: Dened area of persistent
redness or persistent red, blue or purple hue; stage II:
Partial thickness skin loss involving epidermis and/or
Figure 1: Pulsed magnetic eld therapy equipment
Table 1: Specications of equipment ‘Pulsatron’
Features Specifications
Weight 40 kg
Dimensions (L 3 B 3 H) 7 ft 3 4 ft 3 4ft
Field intensity 750-1500 nano Tesla
Accuracy
1 /- 50 nano Tesla
Wave forms Square and sine
Frequency range 0-100 Hz
DC fields Can be delivered
Power 22V AC, 50-60 Hz
Power consumption 10 watts (Maximum)
624 Neurology India | Sep-Oct 2009 | Vol 57 | Issue 5
Gupta, et al.: Pulsed magnetic eld therapy in pressure ulcers
dermis; stage III: Full thickness skin loss with damage
and necrosis to subcutaneous tissue with wound
extending down but not through underlying fascia; and
stage IV: Full thickness skin loss with tissue destruction,
damage to muscle, tendon, bone or joint capsule.
Colored photographs of ulcers were taken at the time
of recruitment into the study and at the end treatment
protocol. An investigator/evaluator, blind to the
randomization of the ulcers, assessed the pressure sores
weekly and recorded the observations using BJWAT and
NPUAP ulcer stage form.
Statistical analysis
Data were analyzed using SPSS version 11.0 software.
Data were described using frequencies; mean, median,
standard deviation, minimum, and maximum values.
Comparison between treatment and sham group was
done with Mann-Whitney U test for BJWAT and NPUAP
ulcer grade, whereas Wilcoxon signed rank test was used
to compare within the group. The two-tailed level of
signicance was kept at 0.05. Intention to treat analysis
was used.
Results
The study included 12 patients (M:F, 9:3), six (mean
age 27.83 6 14.64 yrs, (12-50 yrs) in Group I (treatment
group) and six (mean age 28.83 6 11.10 yrs (15-48 yrs)
in Group II (sham group). The mean duration of the
illness at the beginning of study was 6.42 6 6.40 months
(one to 20 months) while the mean duration of pressure
ulcer was 103.75 6 113.70 days (10 to 420 days). The
mean duration of stay in the rehabilitation unit was
98.66 6 66.58 days (24-193 days). The number of
treatment sessions in patients ranged from 22-30,
mean of 29.06 6 2.29. There were no non-compliers or
dropouts from the study.
Patients’ demographic prole, diagnosis, site of pressure
ulcer, at-admission and at-discharge BJWAT and NPUAP
ulcer staging is given in Table 2. The most common site
of pressure ulcer was sacral region (n 5 9), followed
by gluteal region (n 5 6), heel (n 5 5). Thirteen ulcers
(54.16%) were stage IV (eight and ve in treatment and
sham groups, respectively) and 11 ulcers (45.84%) were
stage III (ve and six in treatment and sham groups,
respectively) at the beginning of the study. At the end
of the study, two patients had stage I ulcers (8.33%), four
had stage II (16.67%), 16 had stage III (66.67%), and two
had stage IV ulcers (8.33%).
There was signicant healing of the ulcers (NPUAP
ulcer stage) at the end of the study in both the
treatment and sham groups (P 5 0.008 and 0.014,
respectively). However, when comparision was done
between treatment goup and sham group there was
no significant difference (P 5 0.649). There was
significant differences in BJWAT scores, admission
and discharge, in both treatment and sham group
(P 5 0.001 and 0.003, respectively,). However, when
the comparisons were made between the groups there
mas no signicant difference (P 5 0.361). Two patients
(8.33%) showed complete healing of pressure ulcers in
less than 30 sessions and both of thme received PEMF
therapy. In none of the patients there was worsening
of pressure ulcers (both groups) and there were no
complications attributable to pulsed electromagnetic
eld (PEMF) therapy.
Discussion
Several studies have assessed the efcacy of PEMF therapy
in the healing of pressure ulcers. Two of them were
randomized control trials
[17,18]
and others are prospective
studies.
[12,22]
The efcacy of PEMF has also been studied
in patients with venous ulcers
[13,23,24]
and in leprosy
patients with nonhealing ulcers.
[25]
In the randomized
control trail by Comorosan et al.,
[17]
20 patients received
PEMF and five patients each received conventional
therapy and conventional therapy and sham therapy for
a maximum period of two weeks. Healing of pressure
ulcers was signicant in the treatment group compared
to other two groups.
[17]
In the other randomized control
trial by Salzburg et al., (1995),
[18]
30 male patients with
spinal cord injury and grade II and III pressure ulcers
were given either PEMF or sham treatment for 12 weeks
or until the ulcers healed. Authors noted no signicant
difference between the treatment and the sham group in
healing of pressure ulcers. Healing was better in stage
II ulcers in the treatment group. Systemic review of the
efcacy of PEMF in the healing of pressure ulcers by
Olyaee et al.,
[19]
concluded that the present data provide
no reliable evidence of benet from electromagnetic eld
therapy and recommended more randomized control
trials with larger sample size.
In the present randomized control trial study, BJWAT
scores and NPUAP ulcer staging were used for assessment
of healing of pressure ulcers. No signicant difference in
the ulcer healing was found between treatment and sham
group using both the scales. However the sample size was
too small. Other measures, such as, supportive surfaces,
turning and bed positioning, moist dressing, debridement
of the Escher, and adequate nutrition have important
contribution in healing of ulcers. How much each of these
measures have contributed for healing of pressure ulcers,
was difcult to ascertain in this study because of the small
sample size and inability to exclude confounding effects
of these measures provided to both the groups.
Pressure ulcers in stage III and IV usually require
surgical closure and probably electromagnetic therapy
625Neurology India | Sep-Oct 2009 | Vol 57 | Issue 5
Gupta, et al.: Pulsed magnetic eld therapy in pressure ulcers
as an adjuvant therapy. Earlier randomized control
studies
[17,18]
included stage II and III ulcers in their study.
In the present study, no deliberate attempt was made
to include stage IV ulcers and the patients admitted
during the study period had only stage III and IV
pressure ulcers. Four patients underwent surgery (one
from treatment group and three from sham group); two
patients required skin grafting and two needed ap
mobilization and closure of the wound after completion
of treatment sessions.
There are certain limitations of the present study, such
as, the small sample size, use of restricted frequency
of PEMF (1 Hz), and short duration of exposure. Only
stage III and IV ulcers were included in the study. Ulcers
in these stages usually require surgical closure and
electromagnetic therapy has to be used as an adjuvant
therapy. Only 1 Hz frequency was used as advised by
the manufacturer. Same frequency was used in the earlier
studies using the same equipment for the treatment
of pressure ulcers. Probably feature randomized trails
should consider the frequency and period of exposure of
PEMF, stage of ulcer, large sample sized while designing
the study.
References
1. Fife C, Otto G, Capsuto EG, Brandt K, Lyssy K, Murphy K,
et al
.
Incidence of pressure ulcers in a neurologic intensive care unit. Crit
Care Med 2001;29:283-90.
2. Bergstrom N, Braden B, Kemp M, Champagne M, Ruby E. Multi-site
study of incidence of pressure ulcers and the relationship between
risk level, demographic characteristics, diagnoses and prescription of
preventive interventions. J Am Geriatr Soc 1996;44:22-30.
3. Groeneveld A, Anderson M, Allen S, Bressmer S, Golberg M, Magee B,
et al
. The prevalence of pressure ulcers in a tertiary care pediatric and
adult hospital. J Wound Ostomy Continence Nurs 2004;31:121-2.
4. Gunningberg L. EPUAP pressure ulcer prevalence survey in Sweden:
A two-year follow-up of quality indicators. J Wound Ostomy Continence
Nurs 2006;33:258-66.
5. Shahin ES, Dassen T, Halfens RJ. Pressure ulcer prevalence and
incidence in intensive care patients: A literature review. Nurs Crit Care
2008;13:71-9.
6. Lahmann NA, Halfens RJ, Dassen T. Pressure ulcers in German
nursing homes and acute care hospitals: Prevalence, frequency and
ulcer characteristics. Ostomy Wound Manage 2006;52:20-33.
7. Capon A, Pavoni N, Mastromattei A, Di Lallo D. Pressure lucer risk in long-
term units: Prevalence and associated factors. J Adv Nurs 2007;58:263-72.
8. Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T.
Pressure ulcer prevalence in Europe: A pilot study. J Eval Clin Pract
2007;13:227-35.
9. Uzun O, Tan M. A prospective, descriptive pressure ulcer risk factor
and prevalence study at a university hospital in turkey. Ostomy Wound
Manage 2007;53:44-56.
10. Sussman C. Management of wound healing with physical therapy
technologies. In: Sussmann C and Bates- Jansen BM (editors) Wound
care A collaborative practice manual for physical therapists and nurses.
Aspen publishers: Maryland;1998. p. 347-56.
11. Weiss DS, Kirsner R, Eaglstein WH. Electrical stimulation and wound
healing. Arch Dermatol 1990;126:222-5.
12. Sheffet A, Cytryn AS, Louria DB. Applying electric and electromagnetic
energy as adjuvant treatment for pressure ulcers: A critical review.
Ostomy Wound Manage 2000;46:28-33,36-40,42-4.
13. Stiller MJ, Pak GH, Shupack JL, Thaler S, Kenny C, Jondreau L.
A portable pulsed electromagnetic field (PEMF) device to enhance
healing of recalcitrant venous ulcers: A double-blind, placebo-con-trolled
clinical trial. Br J Dermatol 1992;127:147-54.
Table 2: Demographic prole, BJWAT and ulcer grading at the beginning and completion of the study
Age
(Yrs)
Sex Diagnosis Tt. vs
Sham
Site of
ulcer
BJWAT
score (I)
BJWAT score
(Compl.)
Ul.grade
(I)
Ul.grade
(Compl.)
50 M Pott’s spine Tt. Sacral 42 23 4 3
Lt. GT 37 22 4 3
15 M Pott’s spine Sham Sacral 43 22 4 3
Lt. Glut 27 18 4 4
36 F TBM Sham Sacral 26 17 4 3
12 M ADEM Tt. Rt. heel 43 25 4 4
Lt. Glut 24 13 3 1
34 F Traumatic myelopathy Sham Sacral 32 21 3 2
Lt. heel 37 20 3 2
Lt. Glut 36 29 4 3
20 M D-L Epend Tt. Sacral 37 21 4 3
30 M TBI with sequelae Sham Rt. Glut 29 23 4 3
27 M Traumatic myelopathy Tt. Rt. Heel 45 16 4 3
Rt. GT 34 21 3 3
Lt. Glut 39 24 3 2
30 F Traumatic myelopathy Tt. Sacral 26 17 4 3
Rt. GT 22 19 4 3
48 M Traumatic myelopathy Sham Sacral 31 18 3 3
Lt. heel 25 20 3 3
14 M Cervical f lorosis Tt. Sacral 32 25 4 3
Rt. heel 29 13 3 1
Lt. Glut 33 22 3 3
24 M Traumatic myelopathy Sham Sacral 25 20 3 2
Rt. GT 22 19 3 3
Tt - Treatment; BJWAT - Bates Jensen Wound Assessment Tool; I - Initial scores; Compl. - Completion of study; Ul. Grade - Ulcer grade according to NPUAP;
Lt. GT - Left Great Trochanter; Rt. GT - Right Great Trochanter; Lt. Glut. - Left Gluteal region; Rt. Glut. - Right Gluteal region; TBM - Tubercular Meningitis; ADEM - Acute
Demyelinating Encephalo-myelitis; D-L Epend. - Dorso-lumber Ependymoma
626 Neurology India | Sep-Oct 2009 | Vol 57 | Issue 5
Gupta, et al.: Pulsed magnetic eld therapy in pressure ulcers
14. Markov MS. How to go for magnetic field therapy. EMF therapeutics
Inc.; 5-15.
15. Markov MS, Todorov NG. Electromagnetic field stimulation of some
physiological processes. Studia Biophysica 1984;99-151-6.
16. Markov MS. Magnetic and electromagnetic fields-a new frontier
in clinical biology and medicine. Proceedings of the Millennium
International Workshop on Biological Effects in Biology and Medicine-
Crete 17- 20 October 2000363
,
-372 ISBN 960-86733-0-5.
17. Comorosan S, Vasilco R, Arghiropol M, Paslaru L, Jieanu V, Stelea S.
The effect of Diapulse therapy on the healing of decubitus ulcer. Rom
J Physiol 1993;30:41-5.
18. Salzberg CA, Cooper-Vastola SA, Perez F, Viehbeck MG, Byrne DW. The
effects of nonthermal pulsed electromagnetic energy on wound healing
of pressure ulcers in spinal cord-injured patients: A randomized, double-
blind study. Ostomy Wound Manage 1995;41:42-446
,
, 48 passim.
19. Olyaee MA, Flemming K, Cullum NA, Ravaghi H. Electromagnetic
therapy for treating pressure ulcers. Cochrane Database of Systematic
Reviews. 3.2006.
20. National Pressure Ulcer Advisory Panel. Consensus development
conference statement. 1989.
21. Bates Jansen BM. Tools to measure wound healing. In Sussmann C,
Bates- Jansen BM. Wound care: A collaborative practice manual for
physical therapists and nurses. Aspn publishers: Maryland; 1998. p. 115-6.
22. Itoh M, Montemayor JS Jr, Matsumoto E, Eason A, Lee MH, Folk FS.
Accelerated wound healing of pressure ulcers by pulsed high peak power
ecectrmagnetic energy (Diapulse). Decubitus 1991;4:24-529
,
-34.
23. Ieran M, Zaffuto S, Bagnacani M, Annovi M, Moratti A, Cadossi R. Effect
of low frequency pulsing electromagnetic fields on skin ulcer of veous
origin in humans: A double-blind study. J Orthop Res 1990;8:276-82.
24. Kenkre JE, Hobbs FD, Carter YH, Holder RL, Holmes EP.
A randomized controlled trial of electromagnetic therapy in the primary
care management of venous leg ulceration. Fam Pract 1996;13:236-41.
25. Sarma GR, Subrahmanyam S, Deenabandhu A, Babu CR,
Madhivathanan S, Kesavaraj N. Exposure to pulsed magnetic fields in
the treatment of plantar ulcers in leprosy patients-A pilot, randomized,
double-blind, controlled clinical trial. Indian J Lepr 1997;69:241-50.
Accepted on 06-03-2009
Source of Support: Nil, Conict of Interest: None declared.
