Meta analysis of clinical efficacy of pulsed radio frequency

REVIEW AND META-ANALYSIS
Meta-Analysis of Clinical Efficacy of Pulsed Radio Frequency
Energy Treatment
Lifei Guo, MD, PhD, FACS,∗
Nicole J. Kubat, PhD,† Teresa R. Nelson, MS,‡ and Richard A. Isenberg, MD†
Objective: To statistically evaluate published clinical efficacy data related
to the use of pulsed radio frequency energy (PRFE) therapy in 3 clinical
applications.
Background: Numerous clinical studies have reported efficacy outcomes for
PRFE therapy use in the palliative treatment of both postoperative and non-
postoperative pain and edema, and for its use as an adjunctive wound-healing
(WH) therapeutic. Although diverse in design and endpoint, these studies
are amenable to systematic review using both a vote-counting and P-value
combination meta-analytic technique.
Methods: A meta-analysis of efficacy outcomes reported in clinical trials
was performed using a vote-counting procedure. In addition, when possible,
the sum of logs method of P-value combination was used to determine a
significance level for the combined evidence within each endpoint and clinical
area.
Results: Of the 186 clinical articles identified after application of selection
criteria, there were 25 controlled trials that met criteria for inclusion in vote-
counting and P-value combination methods and were used for formal statis-
tical analysis. In total, 1332 patients receiving PRFE treatment were studied.
Vote-counting procedure applied to clinical outcomes from controlled studies
resulted in a greater number of positive outcomes than neutral outcomes, and
zero negative outcomes, for each of the clinical application groups evaluated.
The sum of logs P-value method found statistically significant improvement
in pain, reduction in edema, and improvement in WH outcomes.
Conclusions: On the basis of statistical evaluation of published clinical effi-
cacy data, there is strong statistical evidence that PRFE therapy is effective
in the treatment of postoperative and nonpostoperative pain and edema and in
WH applications.
(Ann Surg 2012;255:457–467)
Pulsed radio frequency energy (PRFE) therapy involves the lo-
cal delivery of pulsed, shortwave radio frequency (RF) energy
at a carrier frequency between 13 and 27.12 MHza
to a target tis-
sue without the intended generation of deep heat. The treatment is
noninvasive, relatively low cost, and easy to administer, providing
it with a number of desirable advantages. Numerous clinical studies
over the past several decades have investigated the efficacy of PRFE
therapy for a number of clinical applications. Although diverse in
design and endpoint, these studies are amenable to systematic review
From the ∗
Department of Plastic Surgery, Lahey Clinic Medical Center, Burlington,
MA; †Regenesis Biomedical, Inc, Scottsdale, AZ; and ‡Technomics Research,
LLC, Minneapolis, MN. Dr. Kubat is an independent contract consultant.
Received for publication October 27, 2010; revision April 28, 2011; accepted
November 30, 2011.
Disclosure: No support was received for this research article.
Reprints: Lifei Guo, MD, PhD, FACS, Department of Plastic Surgery, La-
hey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805. E-mail:
lifei.guo@lahey.org
Copyright C 2012 by Lippincott Williams & Wilkins
ISSN: 0003-4932/12/25503-0457
DOI: 10.1097/SLA.0b013e3182447b5d
aIn general, PRFE treatment devices described in clinical articles use a carrier
frequency of 27.12 MHz.
using vote-counting and P-value combination techniquesb
allowing
for meaningful aggregation of study results.
Pulsed RF energy therapy has been studied for use as a pal-
liative treatment for both postoperative (PO) and nonpostoperative
(NPO) pain and edema, and as a wound-healing (WH) therapeutic
in soft tissue. Postoperative patient care is an important health care
issue, and patient outcomes in the days immediately after surgery can
have an important impact on long-term patient recovery. Greater pain
reported days after surgery, for example, has been associated with
poorer long-term outcomes, specifically with respect to long-term
pain, physical functioning, and perceived recovery.1
Traumatic in-
jury and certain degenerative disorders are also associated with pain
and/or edema, and the effectiveness of PRFE therapy at treating these
conditions arising from nonsurgical origins has been investigated as
well. A third application for which there is a growing amount of
clinical data is the use of PRFE therapy in the treatment of soft-
tissue wounds such as pressure ulcers and surgical wounds. Pulsed
RF energy therapy has been reported to promote healing of chronic
wounds otherwise nonresponsive to standard of care treatment, such
as chronic lower extremity wounds in patients with diabetes.2,3
Effec-
tive wound therapeutics that obviate the need for surgical intervention
are especially important in this particular population, which has a high
incidence of nontraumatic lower limb amputation.4
An analysis of the available clinical data supporting the use
of PRFE therapy in these 3 intended uses was performed to provide
a statistical basis for efficacy of the treatment. In addition, variables
related to pathology, anatomy, duration of symptoms, duration of
therapy, and technology were also examined for relevance to efficacy
outcomes.
METHODS
Literature Search and Selection Criteria
The literature search utilized several electronic medical and
academic bibliographic databases to ensure all available published
literature was included in the review. The databases utilized included
PubMed, Academic Search Premier, CINAHL, Wiley Interscience,
and Medline. Key search terms included “pulsed electromagnetic
field” or “PEMF,” “shortwave diathermy,” “electromagnetic energy,”
“electromagnetic field” or “EMF,” “electromagnetic therapy,” “elec-
tromagnetic radiation,” “pulsed radiofrequency” or “PRF,” “pulsed
electrical energy, “electrotherapy,” “pulsing EMF,” “Diapulse,” and
“high frequency.” Key words were used individually and in combi-
nation. Publications as of June 2009 were included in the review.
Results of the electronic search were then sorted by title for applica-
bility to the subject, with titles referencing in vivo human application
of electromagnetic energy included. Titles referencing industrial and
bone-growth applications of RF were excluded, as were titles referenc-
ing static magnetic (eg, not electromagnetic) fields. The title-sorted
electronic search was further augmented by inclusion of relevant
articles referenced within the articles generated from the search.
bDue to the diversity of design and endpoint, the studies are not amenable
to a meta-analysis that provides an overall estimate of effect size in a single
scale for each endpoint.
Copyright © 2012 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 255, Number 3, March 2012 www.annalsofsurgery.com | 457

Guo et al Annals of Surgery r Volume 255, Number 3, March 2012
Only those publications that were reviews, standards, primary scien-
tific reports, or primary clinical study reports, published in English,
pertaining to PRFE were retained for further review. Editorials, per-
sonal communications, and foreign language articles were excluded.
Articles pertaining to electromagnetic field technologies operating in
frequency bands other than the shortwave bandc
were excluded.
Clinical Application Categories
Studies were categorized into groups based on broad categories
of clinical application that included PO, NPO, and WH studies. The
endpoints of interest within the PO and NPO clinical areas included
direct measurements of pain and edema. The endpoints of interest
for the statistical analysis within the WH application were those end-
points that described the WH process. Studies within the PO, NPO,
and WH categories were further categorized on the basis of the qual-
ity of evidence provided. The majority of the studies were controlled
studies that provided a within-study comparison to a concurrent con-
trol group utilizing routine medical care with or without a “sham”
device. Concurrently controlled studies compared with “sham” or
standard of care in the PO, NPO, and WH categories with endpoint
of interest information were considered evaluable for the statistical
analysis. Studies that did not meet criteria were those that reported on
patients outside the indicated population (eg, patients ≤18 years of
age, treatment of deep tissue, or treatment of bone structures), were
single-arm or case studies, were compared with another treatment
modality, or those articles in which specific pain or edema results
were not reported.
Outcome Classification
Each study that met criteria was reviewed and categorized as
positive, neutral, or negative for PRFE efficacy, that is, a vote-counting
procedure was used.5
Positive was defined as statistically and/or clin-
ically significantly better results associated with PRFE therapy as
compared with routine medical therapy. Neutral was defined as simi-
lar results for both PRFE therapy as compared with routine medical
therapy. Negative was defined as statistically and/or clinically signifi-
cantly worse results associated with PRFE therapy as compared with
routine medical therapy.
Statistical Analysis
For studies that were classified with respect to outcome that
reported a P value or in which a P value could be calculated from the
information provided using Fisher exact test (categorical outcome) or
a Z test for 2 independent means (continuous outcome), the sum of
logs method of P-value combination5
was used to determine a signifi-
cance level for the combined evidence within each endpoint and clin-
ical area. Where multiple comparisons were made within a study, the
most conservative P value was used. When the text simply reported a
nonsignificant comparison, P = 1.000 was used. The majority of the
clinical trials reviewed were randomized placebo-controlled double-
blind trials, the gold standard in clinical research. The vote-counting
procedure and P-value combination were used because of the het-
erogeneity of clinical applications, assessments used to measure the
endpoints of interest, and follow-up time. An overall meta-analytic
estimate of treatment effect would not be possible given the amount
of heterogeneity observed.5
To overcome some of the shortcomings
associated with vote-counting procedures, the within-study statisti-
cal design, sample size, estimate of treatment effect, and statistical
significance for the key comparison between treated group versus
cElectromagnetic radiation in the frequency band 10 to 100 MHz is
considered radio frequency. Only those articles defined as shortwave by 21
CFR 890.5290(b), that is, 13 to 27.12 MHz, were included in this analysis.
routine medical therapy are tabulated and discussed along with the
positive, neutral, or negative vote.
RESULTS
Literature Search Results
A total of 186 relevant articles were identified for review after
application of selection criteria. Within these articles, there were 25
controlled trials that met criteria for vote-counting analysis and were
the subject of this review and analysis. In total, 1332 patients receiving
PRFE therapy were studied, with no reported serious adverse events
associated with the use of PRFE therapy (0/1332 patients).
The 25 controlled trials consisted of 6 PO studies, 14 NPO stud-
ies, and 5 WH studies. The PO studies consisted of patients treated
with PRFE after various procedures including oral, foot, breast aug-
mentation, and plastic (eye) surgeries. The NPO studies consisted of
patients treated with PRFE for various soft-tissue disorders involving
trauma, including sprains, lacerations, fractures, childbirth, whiplash
and posttraumatic algoneurodystrophy, and neuromas, and degener-
ative disorders including osteoarthritis and low back pain. The WH
studies consisted primarily of patients treated for pressure ulcers and
some surgical wounds and partial amputations. The follow-up time
ranged from 1 to 7 days for the PO group, immediate to 10 years
for the NPO group, and 5 days to 4 weeks for the WH group. The
duration of symptoms before treatment for the NPO and WH groups
ranged from less than 24 hours to 5 years, and immediate (upon suture
removal) to more than 30 days, respectively.
Technologies included in the review were capable of delivering
PRFE at a carrier frequency of 27.12 MHz resulting in nonthermal ap-
plication. A summary of devices used and device-related parameters
reported for each article is provided in Table 1.
Efficacy Outcomes
The measured efficacy outcomes that were most consistently
reported were pain and edema within the PO and NPO studies, and
rate of WH within the WH studies. However, although these out-
comes were consistently reported, the manner in which they were
reported was highly variable. Therefore, each outcome was evaluated
individually as follows.
Pain
Focusing on the reported outcome of pain, the measures re-
ported throughout the PO and NPO literature included patient assess-
ments rated “none, mild, or considerable,” “reduced, no change, or
worse,” or “no, mild, moderate, or severe.” Other measures included
utilizing pain scales from 1 to 4 (4 being severe pain), 1 to 5 (5 being
severe pain), visual analog scale score from 0 to 10, 0 to 15, or 0 to
100, and the Western Ontario and McMaster Universities Osteoarthri-
tis Index pain scales (0–10). Therefore, by giving each study a vote
and accumulating the within-study P values across the studies that
report pain, it becomes clear that regardless of the measures utilized,
the application of PRFE results in a reduction in pain when compared
with a control.
A total of 16 controlled trials included in this review reported
pain outcomes (5 PO and 11 NPO) with a total of 936 patients actively
treated with PRFE (350 PO and 586 NPO) and 962 patients in the
control group (317 PO and 645 NPO).6–10,12–22
Of the 16 controlled
studies, 11 were randomized controlled trials (4 PO and 7 NPO)
and 11 were blinded studies (3 PO and 8 NPO). Fourteen of the 16
trials (4 PO and 10 NPO) were included in the P-value combination
analysis.
Table 2 outlines the reported pain information by article for
the study design, number of patients enrolled, clinical area, duration
of symptoms, minutes of therapy, vote, and study finding with the
458 | www.annalsofsurgery.com C 2012 Lippincott Williams & Wilkins

Annals of Surgery r Volume 255, Number 3, March 2012 PRFE Efficacy Meta-Analysis
TABLE 1. Therapy Regimen Parameters by Article
Device-Related Parameters (Reported) Time-Related Parameters
Power Driving the
Treatment Coil (W)b
Author Devicea
Pulse/
second
(pps)
Pulse
Width
(μs) Mean Peak Other
Total
Minutes of
Therapy
Total Minutes
of Energy
Exposure
Kaplan and Weinstock6 Diapulsec 600 65 38d 975 90 3.51
Aronofsky7 Diapulse 600 65 38 975 40 and 55e 1.56 and 2.15
Rhodes8 Diapulse 400–600 65 7.6–38 293–975 50 0.46
Heden and Pilla9 SofPulsef 2 2000 NRg h 660 2.64
Hutchinson et al10 Diapulse 500 65 NR 30 0.98
Nicolle and Bentall11 Bentalli 1000 100 NR 1440 144
Wilson12 Diapulse 600 65 38d 975 180 7.02
Barclay et al13 Diapulse 600 65 11.4–38d 293–975 420 3.85
Foley-Nolan et al14 NR 450 60 NR j 10080 272.16
Comorosan et al15 Diapulse 80–600 65 1.5–38 293–975 300k 8.37
Foley-Nolan et al16 NR 450 60 NR j 40320 1088.64
Pennington et al17 Diapulse NR 65 NR 70 NDl
Shandles et al18 Diapulse 400 and
600m
65 ND and 38d NRn and 975 Varied ND
Barker et al19 Therafield
Betao
640 65 NR 135 5.62
Grant et al20 Megapulsep 100 65 NR 30 0.2
Callaghan et al21 Megapulse 400 200 and
400q
10 and 20 125d 120 9.6 and 19.2
Laufer et al22 Curapuls
670r
110 and
300s
82 and 300 1.8 or 18 200 180 1.62 and 16.2
Jan et al23 Curapuls
419
NR NR NR 600 ND
Pasila et al24 Diapulse
and
Curapuls
NR NR 38 and 40t ND 60 ND
Buzzard et al25 Curapuls
403
26 200 35u 150 0.78
Cameron26 Diapulse 400 65 NR 160 4.16
Goldin et al27 Diapulse 400 65 25.3 975 270 7.02
Salzberg et al28 Diapulse 80–600 65 1.5–38d 293–975 5040 111.4
Kloth et al29 NR 600 65 NR v 600 23.4
Muirhead et al30 Curapuls 20–46 400 8–18.4d 1000 116 1.5
a
A carrier frequency of 27.12 MHz (or 27 MHz) was reported for all studies.
b
Does not reflect the power in the tissue target. It is possible to estimate such power if the actual electromagnetic field amplitude emitted by the device is known and if the
magnetoelectric properties of the tissue can be estimated or measured.
c
Diapulse Corporation, USA.
d
Calculated based on values reported.
e
Two PRFE treatment groups: one group received therapy both pre- and postsurgery, the other group received postsurgery therapy only.
f
Ivivi Technologies, USA.
g
NR: not reported
h
Reported as corresponding to average induced electric field of 32±6 mV/cm in tissue target.
i
Proprietary
j
Approximate power per unit area reported as 1.5 mW/cm2
at skin surface.
k
Includes PRFE therapy administered locally and at sympathetic ganglia.
l
ND: not determined (could not be calculated on the basis of data reported).
m
Two target tissues: wound (600 pps) and epigastrium (400 pps).
n
Two power settings were used, with peak power reported for the highest setting only.
o
Therafield Beta, United Kingdom.
p
Electro-Medical Supplies, United Kingdom.
q
Two treatment groups.
r
Enraf Nonius, The Netherlands.
s
Two treatment groups: (110 pps/82 μs) and (300 pps/300 μs).
t
Two treatment groups: Diapulse (38 W) and Curapuls (40 W).
u
Did not state whether the value reported was mean or peak power.
v
Peak magnetic field in tissue reported as approximately 2 G, reported as corresponding to a peak induced electric field of 1V/cm and current density of 1 mA/cm2
in a typical
wound target.
associated P value that was used in the combination analysis. As seen
in the table, there were 11 positive studies (4 PO and 7 NPO), 5 neu-
tral studies (1 PO and 4 NPO), and 0 negative studies demonstrating
a majority of applications resulted in significant reductions in pain.
The overall vote-counting procedure and P-value combination for
reported pain outcomes clearly demonstrates a clinically and statisti-
cally significant improvement for patients receiving active treatment
(PO: P < 0.0001, NPO: P < 0.0001).
There was 1 study within the NPO category that had pain
outcomes reported but was not included in the vote-counting and
C 2012 Lippincott Williams & Wilkins www.annalsofsurgery.com | 459

TABLE 2. Articles That Met Criteria for and Were Included in Vote Counting and P-Value Combination With Reported
Pain Outcomes
Author
Study Design
(T: n, C: n) Clinical Area
Duration of
Symptoms
Minutes of
Therapya Measure
Follow-Up
Time
Statistical Result
(P) Vote
PO
Kaplan and
Weinstock6
Randomized/
blinded (T: 50,
C: 50)
Various foot
surgeries
PO Minimum of
90
Grades 1–4
(1 being no
pain)
>3 d Less grade 3 & 4 in
T (T: 30% vs C:
60%, (P = 0.0046)
+
Aronofsky7 Randomized
(T1: 30, T2:
30, C: 30)
Various oral
surgeries
PO T1: 55
T2: 40
None,
moderate,
considerable
72 h Higher proportion
of no pain
associated with
treatment (T1: 63%,
T2: 40%, vs C: 7%,
(P ≤ 0.0057)
+
Rhodesb8 Controlled
case series (T:
189, C: 188)
Dental
problems
requiring
surgery
PO 50 Days until
pain resolved
NA Observed 10.04-day
reduction in average
time until pain
resolved in T
compared with C (T:
0.97 vs C: 11.01, no
P value available)
+
Heden and
Pilla9
Randomized/
blinded (T: 14,
C: 12)
Breast
augmentation
PO 660 VAS (0–100) 7 d Faster rate of
improvement
associated with T
(Slope for T is 1.8X
greater than for C, P
< 0.001c)
+
Hutchinson
et al10
Randomized/
blinded (T: 37,
C: 37)
Oral surgery PO 30 None, mild,
moderate,
severe
5 d No signiﬁcant
differences were
found (P = 1.000)
o
NPO
Wilson12 Matched case
control,
blinded (T: 20,
C: 20)
Ankle
inversion
injuries
<72 h 180 0–4 (4 being
severe)
3 d Positive (T patient
progress better than
matched pair) = 13,
Negative (T patient
progress worse than
matched pair) = 1,
None (no clear
preference) = 6,
P = 0.002c
+
Barclay et al13 Controlled
case series (T:
114, C: 116)
Hand/thumb
injuries
<36 h 420 1–5 (5 being
severe)
7 d Shows more average
improvement
associated with T vs
C (T: 1.79 grade
change vs C: 0.84
grade change (no P
value available))
+
Foley-Nolan
et al14
Randomized/
blinded (T: 10,
C: 10)
Neck pain >8 wk 10,080 VAS (0–10) 3 wk Shows more
improvement
associated with T vs
C (T: 3.00 score
change vs C: 1.25
score change, P <
0.023c)
+
Comorosan
et al15
Matched case
control (T: 45,
C: 20)
Posttraumatic
algoneurodys-
trophy after
contusions or
fractures
2–6 wk NR None, mild,
moderate,
severe
15 d 82% of patients
reported none or
mild pain in T vs
15% in C (P <
0.0001)
+
Foley-Nolan
et al16
Randomized/
blinded (T: 20,
C: 20)
Acute
whiplash
injuries
<72 h 40,320 VAS (0–10) 2, 4, and
12 wk
T shows more
improvement by
2 wk (p < 0.05c)
and 4 wk (P <
0.05c), but by 12 wk
groups are the same
+d
(Continues)

TABLE 2. Articles That Met Criteria for and Were Included in Vote Counting and P-Value Combination With Reported Pain
Outcomes (Continued )
Author
Study Design
Duration of
Symptoms
Minutes of
Therapya Measure
Follow-Up
Time
Statistical Result
(P) Vote
Pennington
et al17
Randomized/
blinded (T: 25,
C: 25)
Grades I and II
acute sprains
<72 h 70 Reduced, no
change, worse
Same day 64% T have reduced
pain vs 33% in C,
(P = 0.0465)
+
Shandles et al18 Controlled
case series (T:
101, C: 216)
Heel neuroma 5 yr Minimum of
40
Cure without
surgery (y/n)
1–10 yr The rate of cure for
T (95%) is higher
than C (75%),
(P < 0.0001)
+
Barker et al19 Randomized/
blinded (T: 34,
C: 39)
Lateral
ligament
sprains of the
ankle
<36 h 135 VAS (0–10) 15 d Groups show no
difference in pain at
follow-up (T: 0.1 vs
C: 0.2, P = 0.5090)
o
Grant et al20 Randomized/
blinded (T:
135, C: 139)
Operative
vaginal
deliveries or
sustained
perineal
trauma or
severe perineal
edema,
bruising, or
hematomas
<24 h 30 VAS (0–100) 36 h Same improvement
in VAS reported at
36 he (T: 21.6 vs C:
21.1 (P = 0.8599)
o
Callaghan et al21 Randomized/
blinded (T1:
9f, T2: 9, C: 9)
Knee
osteoarthritis
NR 120 VAS (0–10) 2 wk Groups were
comparable at
follow-up (T1: 5.5,
T2: 5.0 vs C: 6.3)
(P ≥ 0.4673)
o
Laufer et al22 Randomized/
blinded (T1:
27g, T2: 37,
C: 31)
Grades II or
III knee
osteoarthritis
>3 mo 180 WOMAC
(0–10)
3 wk The improvement is
comparable among
groups (T1: 0.4, T2:
0.4 vs C: 0.5,
P = 1.000c)
o
a
Calculated by reported minutes of treatment × number of treatments per day × number of days treated.
b
Reported subset of patients age 21 years and older.
c
P value as reported in publication.
d
Earlier pain relief is a positive outcome for acute whiplash even though pain relief was achieved at 12 weeks in both treated and control groups.
e
The most relevant comparison is at 36 hours because treatment with PRFE was given for up to 3 treatments within the first 36 hours.
f
T1 = pulse width of 200 μs and T2 = pulse width of 400 μs, all other technological parameters were consistent.
g
T1 = pulse width of 300 μs and pulse frequency of 300 Hz, T2 = 82 μs and pulse frequency of 110 Hz.
C indicates control group; o, neutral; T, treatment group; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; VAS, visual analog scale.
P-value combination analysis. The reason for exclusion was a poten-
tial study bias present at baseline because patients were allowed to
choose their therapy (treatment vs control).23
Edema
Focusing on the reported outcome of edema, the measures re-
ported throughout the PO and NPO literature included patient assess-
ments rated as “none, mild, moderate, or severe,” “none, moderate, or
considerable,” “no swelling, just-visible swelling, moderate swelling,
severe swelling,” “improved, same, or worse,” or a scale of 1 to 4
(1 being least amount of edema). Other measures included using
volumetric displacement methods, circumferential measurements, or
days until all edema was gone. Again, it becomes clear that the appli-
cation of PRFE results in a reduction in edema when compared with
a control, regardless of the type of measures utilized.
A total of 14 studies included in this review reported edema
outcomes (5 PO and 9 NPO) with a total of 958 patients actively
treated (355 PO and 603 NPO) and 803 patients in the control group
(324 PO and 479 NPO).6–8,10–13,15,17,19,20,23–25
Of the 14 controlled
studies, 8 were randomized controlled trials (3 PO and 5 NPO) and 7
were blinded studies (2 PO and 5 NPO). Eleven of the 14 controlled
clinical trials were evaluable for the P-value combination analysis
(3 PO and 8 NPO).
Table 3 outlines the reported edema information by article for
the study design, number of patients enrolled, clinical area, duration
of symptoms, minutes of therapy, vote, and study finding with the
associated P value that was used in the combination analysis. As seen
in the table, there were 9 positive studies (4 PO and 5 NPO), 5 neutral
studies (1 PO and 4 NPO), and 0 negative studies demonstrating a
majority of applications resulted in significant reductions in edema.
Like the reported pain outcomes, the overall vote-counting proce-
dure and P-value combination for reported edema outcomes clearly
demonstrates a clinically and statistically significant improvement
for patients receiving active treatment (PO: P < 0.0001, NPO: P <
0.0001).
Wound Healing
The same vote-counting procedure and P-value combination
analysis was conducted for the WH category of articles as was used for
PO and NPO articles. Again, on the basis of the results of the review,
regardless of the type of measures used within the study, it becomes
obvious that the application of PRFE results in improved healing

TABLE 3. Articles That Met Criteria for Vote Counting and P-Value Combination With Reported Edema Outcomes
Author
Study Design
Duration of
Symptoms
Minutes of
Therapya Measure
Follow-Up
Time
Statistical Result
(P) Vote
PO
Kaplan and
Weinstock6
Randomized/
blinded
(T: 50, C: 50)
Various foot
surgeries
PO Minimum 90 Grades 1–4
(4 being
severe)
>3 d Less grade 3 & 4
in T vs C (T: 19%,
vs C: 54%)
(P = 0.0008)
+
Aronofsky7 Randomized
(T1: 30, T2:
30, C: 30)
Various oral
surgeries
PO T1 = 55,
T2 = 40
None,
moderate,
considerable
72 h Higher proportion
of no edema
associated with T
(T1: 77%, T2 53%
vs C: 7%,
P < 0.0001)
+
Rhodes8 Controlled
case series
(T: 189, C:
188)
Dental
problems
requiring
surgery
PO 50 Days until
edema
resolved
NA Observed 8.93d
reduction in
average time until
edema resolved
when T compared
with C (T: 2.61 vs
C: 11.54, no
P-value available)
+
Nicolle and Bentall11 Within patient
controlled
comparison
(T: 19 eyes,
C: 19 eyes)
Blepharoplasty PO 1,440 Improved,
same, worse as
nontreated eye
24 h, 3 d,
6 d
Improved: 11
(58%) Same: 6
(32%) Worse: 2
(11%) (no P-value
available)
+
Hutchinson et al10 Randomized/
blinded
(T: 37, C: 37)
Oral surgery PO 30 No swelling,
just visible
swelling,
moderate, or
severe
3 d, 5 d No signiﬁcant
differences were
found
(P = 1.0000b)
o
NPO
Wilson12 Matched case
control,
blinded
(T: 20, C: 20)
Ankle inversion
injuries
<72 h 180 0–4
(4 being >1.5
in increase in
diameter over
uninjured
ankle)
3 d Positive (T
progress better
than matched pair)
= 9, Negative
(T progress worse
than matched pair)
= 2, None (no
clear preference)
= 9, P = 0.033b.
+
Barclay et al13 Controlled
case series
(T: 114, C:
116)
Hand/thumb
injuries
<36 h 420 1–5
(5: circumference
greater than
normal by
2.0 cm)
7 d Shows more
average
improvement
associated with T
vs C (T: 1.35 vs
C: 0.000, no
P-value available)
+
Comorosan et al15 Matched case
control
(T: 45, C: 20)
Posttraumatic
algoneurodys-
trophy after
contusions or
fractures
2–6 wk NR None, mild,
moderate,
severe
15 d 89% of patients
reported none or
mild edema in T
vs 30% in C (P <
0.0001)
+
Pennington et al17 Randomized/
blinded
(T: 25, C: 25)
Grades I and II
acute sprains
<72 h 70 Volume Same day On average, T had
33 mL more
reduction
compared with C
(T: 44 mL vs C: 11
mL [P = 0.0001])
+c,d
(Continues)

TABLE 3. Articles That Met Criteria for Vote Counting and P-Value Combination With Reported Edema Outcomes (Continued)
Author
Study Design
Duration of
Symptoms
Minutes of
Therapya Measure
Follow-Up
Time
Statistical Result
(P) Vote
Jan et al23 Patient chose
therapy or no
therapy
(T15: 11,
T25: 10, C: 9)
Degenerative
osteoarthritic
knee of grade
3 or less
NR 600 Synovial sac
thickness
After 30
session
Decreased
thickness in T
groups as
compared with C
(T1 and T2:
28%–33% vs C:
no change
P < 0.0001b)
+d,f
Pasila et al24 Randomized/
blinded
(T1g: 100,
T2g: 100,
C: 100)
Foot/ankle
sprains
<4 d 60 Circumference
of ankle and
volume of foot
3 d Curapuls group
provided a
significant
reduction in ankle
circumference
(mm) as compared
with control,
Diapulse did not.
(T1: 4.5, T2 5.0,
C: 2.6). There
were no
statistically
significant
differences
between groups
for the reduction
in volume (mL) of
the foot (T1: 30,
T2: 40, C: 36)
(P = 1.000h)
o
Barker et al19 Randomized/
blinded
(T: 34, C: 39)
Lateral
ligament
sprains of the
ankle
<36 h 135 Volume (ratio
of injured/
noninjured)
15 d Groups are
comparable at
follow-up
(P = 0.7644)
o
Grant et al20 Randomized/
blinded
(T: 135,
C: 139)
Operative
vaginal
deliveries or
sustained
perineal
trauma or
severe perineal
edema,
bruising, or
hematomas
<24 h 30 Edema free
(y/n)
36 h Groups are
comparable at
36 h (P = 0.5549)
o
Buzzard et al25 Randomized
(T: 9, C: 11)
Acute
calcaneal
fractures
16–18 h 150 Measured
circumference
5 d No statistical
difference for any
of the changes
between day 1 and
day 5 (P = 0.22b)
o
a
Calculated by reported minutes of treatment × number of treatments per day × number of days treated.
b
c
“We conclude that nonthermal, pulsed, electromagnetic energy as delivered by Diapulse can be used to decrease swelling and pain in the acutely sprained ankle. This can be
important in a population which is required to wear restrictive footwear and is expected to return to continue active training as rapidly as possible.” (Pennington et al, 1993.)
d
Pennington et al, 1993, and Jan et al, 2006, were removed from the P-value combination analysis to assess the sensitivity of the statistical significance of the P-value combination
analysis to their inclusion. Pennington et al were removed because baseline difference in the foot volume observed between the control and treated groups was larger (143 mL) than the
observed difference in improvement between the groups (33 mL). Jan et al were conservatively removed because of the selection bias evident in pain. Upon removal of both studies, the
significance of the P-value combination analysis was 0.0028. In addition, Pennington et al were included as a nonsignificant study (P = 1.000) with Jan et al removed. The significance
of the P-value combination was 0.0077. The observation of statistically significant effect on edema across studies due to nonthermal shortwave diathermy is unchanged and does not
depend on the inclusion of these 2 studies.
e
T1 = treatment alone, T2 = treatment plus nonsteroidal anti-inflammatory drugs.
f
Included because the study groups were comparable at baseline with respect to the edema measurement; average synovial sac thickness; short-wave diathermy alone 1.66,
short-wave diathermy in combination with nonsteroidal anti-inflammatory drugs, 2.11, versus no treatment (1.94, P > 0.05∗
as reported in the publication).
g
T1 = treatment with Diapulse, T2 = treatment with Curapuls.
h
Conservatively, a P = 1.000 used in the P-value combination analysis because 3 of the 4 comparisons between treated and control in regard to edema measurements were not
found to be statistically significant. The P-value associated with the Curapuls comparison with control for ankle circumference was reported as P < 0.01 in the publication.

TABLE 4. Articles That Met Criteria for Vote Counting and P-Value Combination With Reported WH Outcomes
Author
Study
Design
(T: n, C: n)
Clinical
Area
Duration of
Symptoms
Minutes of
Therapya Measure
Follow-Up
Time
Statistical Result
(P) Vote
Cameron26 Randomized,
blinded (T:
50, C: 50)
Surgical
wound
Immediate 160 Suture
removal (y/n)
5 d 48% sutures removed
by day 5 in T vs 18%
in C,
P = 0.0026b
+
Goldin et al27 Randomized,
blinded (T:
29, C: 38)
Surgical
wound
Immediate 270 % >90%
healed
7 d Proportion of wounds
healed >90% at 7 d
was 59% for T vs
29% for C,
P = 0.0239c
+
Salzberg et al28 Randomized,
blinded
Stage II: (T:
10, C: 10)
Stage IIId:
(T:5, C:5)
Stages II and
III pressure
ulcers in
spinal
cord–injured
patients
NR 5,040 Wound area,
% healed, days
to heal
1 wk and until
healed
Greater % of wound
healed at 1 wk for
T (84%) vs C (40%),
P = 0.015e,f and
lower number of
days to heal for
T (13.0) vs C (31.5),
P < 0.001f
+
Kloth et al29 Randomized,
blinded
(T: 5, C: 5)
Pressure
ulcers in
spinal
cord–injured
patients
>30 d 600 % wound
closure
4 wk 64% wound closure
for T and no change
for C (−8%),
P = 0.016f
+
Muirhead et al30 Randomized
(T: 48, C:
48)
Pretibial
lacerations
Immediate 116 Wound area,
healing time,
healing rate
Time until
healed
Time to heal and rate
of healing was not
statistically different
(P = 0.43f and
P > 0.80e,f)
o
a
Calculated by (reported minutes of treatment × number of treatments per day × number of days treated).
b
Conservatively used P-value associated with overall comparison. This action is conservative because the publication reported an 81-patient single-arm study that validated the
results seen in the all but abdominal surgery subgroup. The analysis for the all but abdominal surgeries subgroup in the double-blind study reported the following proportion of treated
patients with suture removal as compared with control (T: 89%, C: 13%, P < 0.0001). Within the subgroup with abdominal surgery, the proportion with their sutures removed by 5
days was not found to differ between groups (T: 28%, C: 21%, P = 0.5704). The lack of a significant effect in the abdominal surgery subgroup as reported in the publication is due to
conservative behavior on the part of the surgeon to avoid possible wound dehiscence. The 81-patient single-arm study results reported 86% of patients with sutures removed by day 5.
c
P value reported in publication is in error and is reported to be between 0.05 and 0.25.
d
Statistical comparisons between treated and control not performed on stage III ulcers. Three of the 5 healed in treated group versus 0 of the 5 in control. Seventy percent decrease
in wound size in treated group as compared with 21% in control.
e
Conservatively, maximum P value used in P-value combination analysis.
f
characteristics (time, % wound closure, etc) when compared with
a control. A total of 5 randomized, controlled studies reported WH
outcomes with a total of 147 patients actively treated with PRFE and
156 patients in the control group.26–30
Of the 5 randomized studies, 4
were blinded studies and all were included in the P-value combination
analysis.
Table 4 outlines the reported information by article for the
study design, number of patients enrolled, clinical area, duration of
symptoms, minutes of therapy, vote, and study finding with the asso-
ciated P value that was used in the combination analysis. As seen in
the table, there were 4 positive studies, 1 neutral study, and 0 nega-
tive studies demonstrating that a majority of applications resulted in
significant reductions in WH time. Similar to the reported outcomes
for pain and edema, the overall vote-counting procedure and P-value
combination for reported WH outcomes also demonstrate a clinically
and statistically significant improvement for patients receiving active
treatment (P < 0.0001).
DISCUSSION
Statistical Evidence of PRFE Therapy Efficacy in
Multiple Clinical Settings
In evaluating articles that were considered to be scientifically
valid research (randomized studies or controlled case series), with
pertinent technological compatibilities (ie, equivalent carrier frequen-
cies of 27.12 MHz) within the specified patient population (>18 years
of age), it was possible to draw clear conclusions regarding the effi-
cacy of PRFE therapy in multiple clinical settings. Although the liter-
ature regarding the use of PRFE does not report outcome measures,
especially in regard to pain, edema, and WH, in any standard measure,
the application of a well-documented vote-counting procedure and
P-value combination analysis allows for meaningful accumulation of
results across all studies. By applying the vote-counting procedure
and the sum of logs P-value combination method, strong statistical
evidence is provided that demonstrates the efficacy of PRFE in the
treatment of PO and NPO pain and edema and in WH applications.
Additional clinical evidence outside the scope of this analysisd
also supports the findings reported here. Subsequent to the conduct
of this meta-analysis, a double-blind, placebo-controlled study by
Rohde et al31
found a statistically significant reduction in pain, con-
current with a significant reduction in interleukin-1ß levels in wound
dThat is, data published after the meta-analysis was performed, in a
format not identified with the search criteria used (eg, textbook format), or as
a study that did not include a control group (eg, single-arm studies and case
studies).

exudates, in patients receiving PO PRFE therapy compared with con-
trol patients, further supporting efficacy of PRFE therapy in PO pain
management. In regard to edema outcome, Pilla32
reported on a ran-
domized, controlled, multicenter prospective study of 395 patients
with grade 2 lateral ankle sprains treated with PRFE. Edema reduc-
tion in the PRFE-treated group was 7-times that of the sham control
group (P < 0.05).e
Finally, the efficacy of PRFE therapy in WH ap-
plications, particularly for the treatment of recalcitrant wounds, is
supported by numerous case studies in the literature as well.2,3,33–39
Efficacy Outcomes Related to Study Variables
In analyzing the various degrees of efficacy reported in the
literature associated with the application of PRFE, variables related
to pathology, anatomy, duration of symptoms, duration of therapy,
and technology were examined for relevance to study outcome. As
discussed later, among the various potential predictors of efficacy, the
most plausible from the medical perspective is duration of therapy.
In addition, the observation that the treated populations did no better
than the control populations in the neutral studies of PRFE may be
explained as consequent to insufficient energy dosing.
Anatomical and Pathological Variables
It is interesting to note that all of the 8 positive studies in the
NPO category are regarding the treatment of patients with pain and
edema arising from soft-tissue trauma (either primary trauma such as
lacerations, whiplash, or sprains or posttraumatic trauma arising from
algoneurodystrophy or heel neuromas). This finding is consistent with
the supposition that traumatic injury and surgical injury are compa-
rable in terms of the body’s inflammatory response and suggests that
the response to PRFE therapy is comparable as well. In contrast, 2
of the 6 neutral studies in the NPO category are studies related to
the treatment of pain and edema associated with degenerative disease
(such as osteoarthritis) rather than trauma, and there is a higher pro-
portion of positive trials associated with trauma and WH as opposed
to degenerative disease (P = 0.0254). An alternate explanation for the
observed neutral response in osteoarthritis relates to anatomy rather
than pathology. In these articles, PRFE was applied to a joint space,
a region that likely behaves differently than other soft tissues because
of its closed space and limited blood supply. Thus, in general, there is
not yet enough evidence to draw conclusions regarding the efficacy
of PRFE in the treatment of degenerative diseases.
Duration of Symptoms
Excluding the surgical studies (all PO studies and a portion
of WH studies) in which treatment was initiated immediately after
surgery, there is a similarity in regard to durations of symptoms with
respect to positive and neutral studies. The duration of symptoms for
positive studies ranged from less than 36 hours to up to 5 years with
half of the studies (4/8) reporting less than 72-hour (3-day) symptom
duration. Similarly, the neutral studies reported from 16 to 18 hours up
to more than 3 months, with 5 of 7 reporting less than 4-day (84-hour)
symptom duration. This suggests that the cellular response to PRFE
is independent of the duration of the symptoms before treatment.
Therapy Duration and Device Type Used
Although the technologies included in the review were all of
the shortwave diathermy device classification,f
the regimen associ-
ated with each treatment was highly variable. There is statistical
eData published in textbook format (ie, not identified with the search
criteria used in this study).
fUS Food and Drug Administration, Code of Federal Regulations, Title
21, Part 890, Section 890.5290.
evidence that the propensity for a positive study score is associated
with the technology used in the evaluations (P = 0.00056). However,
within each technology, it is not clear that a strong correlation can be
associated with the reported pulse widths, pulse frequencies, or calcu-
lated duty cycles alone. However, a strong correlation is drawn when
evaluating the minutes of therapy applied (and associated calculated
total energy delivered). Therefore, it is not clear whether the technol-
ogy utilized or minutes of therapy applied are the driving factor in
achieving a positive study result.
In evaluating all of the studies that obtained a positive score
in comparison with the studies that were scored neutral, there is a
statistically significant difference in the minutes of therapy applied
(positive = median 300 minutes, neutral = median 120 minutes; P
= 0.0210). The positive studies did not have statistically more total
energy exposure (calculated by [minutes of therapy × duty cycle]/100,
where duty cycle equals pulse width × [pulse frequency/10,000]) as
compared with neutral studies (P = 0.1360); nevertheless, the median
total energy exposure was higher in the positive articles (7.0 minutes)
compared with the neutral articles (1.6 minutes). Figure 1 illustrates
the correlation of minutes of therapy and total energy exposure for
the positive and neutral studies included in this review.
Of the positive studies that overlap in the region of neutral stud-
ies, it is important to note the studies were all PO studies utilizing the
Diapulse technology. Three of the studies were regarding oral surgery
treatments. Recognizing the rich blood supply of the oral cavity and
the typically small surgical field, it is conceivable that oral disorders
may require less PRFE exposure to achieve the desired outcomes.
Notably, the minutes of exposure were greater in the positive oral
studies than in the neutral oral surgery study. The fourth study was
the only study to include the treatment of the epigastrium along with
the PO site, with the theory that treatment of the epigastrium would
increase peripheral blood flow and improve the resulting pain and
edema. As illustrated in the figure, within each clinical application
(ie, PO, NPO, WH), the neutral votes are associated with lower en-
ergy use and the positive votes are associated with higher energy use.
Therefore, the relationship is consistent within clinical application.
Finally, it is also interesting to note there is some evidence to suggest
that the positive studies were more likely to involve a device using a
solitary antenna (eg, Diapulse, SofPulse, Bentall) as opposed to an
antenna plus surface electrodes (eg, Curapuls), whereas the neutral
studies were roughly evenly split between devices with and without
contact electrodes (P = 0.0561).
Concluding Remarks
A meta-analysis performed to evaluate the efficacy of PRFE
therapy in 3 intended uses found statistically significant improvement
in pain, reduction in edema, and improvement in WH outcomes as-
sociated with PRFE therapy use. Overall, duration of therapy was the
most plausible predictor of efficacy in the combined set of clinical
studies evaluated in this analysis. Basic science research aimed at fur-
ther understanding mechanisms underlying the therapeutic effects of
PRFE treatment would be invaluable for further treatment optimiza-
tion. Future clinical studies aimed at defining an optimized therapy
regimen for each clinical application would also be a beneficial direc-
tion for future studies. Along these lines, though not always easy to
measure, data related to biophysical parameters, such as induced elec-
tric field in situ and target tissue impedance, would make it possible
to examine the contribution that such parameters have on therapy effi-
cacy as well. In particular, providing information regarding the actual
power that is delivered to the target tissue, a value that is lacking in
most clinical studies, would be highly useful, and should be possible
to estimate knowing the time-varying property of the wave (carrier
frequency, repetition rate, pulse width), if the actual strength of the
electromagnetic field would be known at the output of the device,

FIGURE 1. Correlation between total minutes of therapy applied and aggregate energy exposure reported for positive and neutral
studies included in this analysis for PO (A), NPO (B), and WH (C) studies. In the figure, filled circles denote positive studies, and
nonfilled circles denote neutral studies, with clinical application denoted by color. Aggregate energy exposure was calculated by
(minutes of therapy × duty cycle)/100, where duty cycle equals pulse width × (pulse frequency/10,000).
and if a good estimate of the magnetoelectric property of the target
tissue is known (ie, how the wave is attenuated in the target tissue).
Although the latter, in particular, can be difficult to estimate, it is
nevertheless recommended that such information be provided when
possible in future clinical studies, which would make it possible to
evaluate the effect of each of these parameters in relation to treatment
efficiency.
ACKNOWLEDGMENTS
The authors thank Jill Munsinger for analysis, writing, and
editing contributions.
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