Pain Medicine 2011; 12: 829832
Wiley Periodicals, Inc.
Pulsed Radio Frequency Energy in the
Treatment of Painful Chronic Cutaneous
Wounds: A Report of Two Cases
Michael Maier, DPM, FACCWS
Cardiovascular Medicine, Cleveland Clinic, Cleveland,
Ohio, USA
Reprint requests to: Michael Maier, DPM, FACCWS,
Lower Extremity Wound Clinic, Cardiovascular
Medicine, Section of Vascular Medicine/J3-5,
Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH
44195, USA. Tel: 216-445-6042; Fax: 216-636-6976;
E-mail: maierm@ccf.org.
Abstract
Setting. Chronic cutaneous wounds may cause
considerable pain, often affecting patient compli-
ance with necessary treatment protocols.
Patients. Two patients are presented who were
unable to comply with compression therapy
because of severe wound pain.
Intervention. Adjunctive pulsed radio frequency
energy was administered for 30 minutes twice daily
through an applicator pad placed directly on the
dressing over the wound area.
Results. Both patients reported immediate, marked
pain reduction, allowing compression therapy. The
ulcers healed completely within 3 weeks for patient
1 and 28 weeks for patient 2.
Conclusions. Further investigation into the efficacy
of pulsed radio frequency energy for the treatment
of painful wounds is warranted.
Key Words. Pain; Chronic Wounds; Pulsed Radio
Frequency; Ulcers
Introduction
Chronic cutaneous wounds may develop from a variety
of causes. Diseases such as diabetes mellitus, atheros-
clerosis, and venous insufficiency, as well as immobility,
advanced age, or other co-morbid factors, predispose
patients to the development of non-healing ulcers.
Decreased cutaneous blood flow and chronic inflam-
pme_1081 829..832
mation impair the normal healing cascade and create
favorable conditions for bacterial growth and infection.
Pain often becomes prohibitive to wound healing in
that patients cannot tolerate necessary treatment moda-
lities such as debridement or compression therapy.
Two patients with lower extremity ulcers are presented
who could not comply with compression therapy due
to uncontrolled pain. Pulsed radio frequency energy
(PRFE; [Provant, Regenesis, Scottsdale, AZ]) was added
to each protocol, producing marked pain reduction and
subsequent complete wound healing.
The Provant PRFE system emits regulated, non-ionizing,
non-thermal radio frequency (RF) energy at 27.12 MHz
through an applicator pad, which is placed directly over
the wound dressing. The pulsed RF (pulse width 42 msec-
onds, pulse frequency 1,000 pulses per second) gener-
ates an electromagnetic field (electrical field strength
591 V/m and magnetic field strength 7 A/m at 5 cm) that
bathes the wound in an imperceptible and well-tolerated
fashion and creates an induced electrical field in target
tissues [1]. Patients or family members can be trained in
the use of the Provant PRFE device, and treatments
can be self-administered at home without skilled super-
vision. Regular clinic visits may be necessary to assure
compliance. The therapy session duration is preset
at 30 minutes. The device is portable and lightweight.
Treatments are generally twice daily.
Case 1
A 25-year-old man with a congenitally small inferior vena
cava (IVC) and history of bilateral lower extremity and
IVC deep vein thromboses developed painful, recurrent
atrophie blanche ulcers on both medial ankles (Figure 1A).
His pain control regimen consisted of: hydrocodone-
acetaminophen 7.5750 mg q46 hours, alprazolam
0.25 mg q8 hours, amitriptyline 75 mg QHS, pregabalin
100 mg q8 hours, and fentanyl transdermal patch
75 mcg/h q48 hours. Despite this regimen, he remained
intolerant of multiple topical dressings and compression
modalities. A trial of PRFE therapy was initiated with
30-minute treatments twice daily. The applicator pad was
placed directly over the wound area on top of the com-
pression wrap and dressing, which were left in place. (The
primary dressing was an absorbent silicone foam pad,
which was changed once daily.) The patient described
an immediate reduction in pain and was able to tole-
rate aggressive compression therapy with daily use of
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Maier
below-knee compression stockings with 3040 mm Hg.
The ulcers healed completely within 3 weeks (Figure 1B).
Case 2
A 58-year-old woman with scleroderma, a connective
tissue disease that results in fibrosis of the skin and visceral
organs accompanied by microvascular disturbances, had
a medial ankle ulcer for approximately 2.5 years. The
wound was extremely painful and severely affected her
quality of life. The patient reported using a number of
wound therapies over time that failed. Assessment of leg
edema was difficult due to characteristic diffuse sclero-
derma skin induration. The wound location, in an area more
typical of venous stasis ulceration, prompted use of titrated
compression therapy. A collagen composite dressing was
used topically along with an elasticized bandage, which she
changed daily. As leg edema was reduced, the wound
surface area decreased as well (Figure 2, A and B).
However, severe small vessel arterial disease and persis-
tent intense pain during flare ups of her scleroderma limited
compliance with compression therapy. Her progress pla-
teaued and the ulcer did not show further improvement for
9 months. Her frail overall medical health and recalcitrant
pain delayed healing significantly. Pain control was poor
with multiple narcotic agents, including the following:
hydrocodone-acetaminophen 7.5750 mg, one to two
tabs q6 hours, alternating with oxycodone-acetaminophen
5325 mg q46 hours, fentanyl transdermal patch
75 mcg/h q72 hours, Neurontin 200 mg QHS (Pfizer, New
York, NY), and zolpidem tartrate 10 mg QHS.
830
Figure 1 Patient 1. (A) Plaque
ulceration of the right medial
ankle. (B) Right medial ankle
ulceration after 10 days of
pulsed radio frequency energy.
In an attempt to achieve better pain control and improve
compliance with compression, a trial of PRFE therapy
was initiated with 30-minute treatments twice daily
with the applicator pad placed directly over the wound
area. The dressing and compression wraps were left in
place. The patient reported marked pain reduction, which
led to improved compliance with compression therapy.
The wound response to continued compression therapy,
advanced topical treatment, and PRFE therapy was dra-
matic. The wound surface area at the beginning of PRFE
therapy was 14.4 cm2 (Figure 3A). At 4 weeks, the surface
area had decreased to 6 cm2 (58% closure). At 11 weeks,
the surface area was 2.9 cm2 (80% closure), and at
28 weeks, the wound was nearly completely healed
(Figure 3B).
Discussion
RF energy has shown utility in many areas of medicine;
however, it is fairly new in the management of chronic
wounds. The use of PRFE as an adjuvant to conventional
therapy in the treatment of pain and edema, and wound
healing has recently been reviewed by Guo et al. [2]. PRFE
has been reported to markedly decrease postoperative
pain and edema, traumatic pain, chronic neck and back
pain [2], chronic spinal radicular pain [3], and pain asso-
ciated with lumbosacral spondylosis [4]. PRFE has been
shown to decrease wound size in patients with long-
standing diabetic foot, venous leg, and decubitus ulcers
[2,511].
Figure 2 Patient 2. (A) At
the time compression therapy
was initiated the wound mea-
sured 9.0 cm 6 cm; surface
area (SA) = 54.0 cm2. (B) At
9 months, the wound mea-
sured 6.5 cm 2.8 cm; SA =
18.2 cm2.

Figure 3 Patient 2. (A) Wound
at 18 months measured
6.0 cm 2.4 cm; surface area
(SA) = 14.4 cm2. Pulsed radio
frequency energy was initiated.
(B) At week 28 of pulsed radio
frequency energy, near com-
plete epithelialization is noted.
As the neural pathways of chronic wound pain are
increasingly understood [12], it is yet unclear how PRFE
modulates chronic wound pain. Moffett [13] and Rohde
[14] have demonstrated widespread up- and down-
regulation of numerous cytokines and growth factors
in response to PRFE in vitro, including matrix metallopro-
teinases and their inhibitors, interleukin-related genes,
interferon-related genes, and tumor necrosis factor-
related genes, suggesting a broad role for PRFE in modu-
lation of inflammation. PRFE is also known to trigger a
brisk rise in secondary messenger activity [15], calcium
binding to calmodulin [16], and a proliferative response in
dermal and epidermal cell lines [17].
Both of our patients had been managed with aggressive
treatment regimens outlined by our Pain Management
service, and nonetheless had severe wound pain that
dramatically affected their day-to-day lives, and precluded
the use of compression dressingsa necessary compo-
nent of their treatment. In light of the recent PRFE litera-
ture, it was the authors hope that this technology would
have a direct pain reduction benefit for these patients.
Although the mechanism of action remains unclear, it
appears that PRFE had the desired effect. Within days
after initiating PRFE, the dramatic reduction in pain facili-
tated improved tolerance of compression therapy with
subsequent wound healing. It is unclear as to whether the
accelerated wound healing was due to improved pain
management (that allowed for compression) or a direct
wound-healing effect of PRFE.
Pain control is an essential part of treatment for patients
with chronic wounds. Not only can pain interfere with
treatment protocols, such as in these patients, but can
directly affect the healing process [18]. Based on these
observations, PRFE may be a useful adjunct for controlling
pain and promoting healing of chronic cutaneous wounds.
Financial Disclosures
None. Author is on the Speaker Panel for Santyl for
Healthpoint.
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