Significant Reduction of Symptoms of Scarring with

case series
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Significant Reduction of
Symptoms of Scarring with
Electrical Stimulation: Evaluated
with Subjective and Objective
Assessment Tools in a Prospective
Noncontrolled Case Series
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From the 1Manchester Institute
of Biotechnology, University of
Manchester, Manchester, UK;
2
University Hospital of South
Manchester NHS Foundation
Trust, Institute of Inflammation
and Repair, Manchester Academic
Health Science Centre, University
of Manchester, Manchester, UK;
3
Fenzian Ltd, Hungerford, Berkshire,
UK; 4Medical Statistics, University
Hospital South Manchester,
Manchester, UK
Abstract: Introduction. Fenzian wave (FW) electrical stimulation has
been shown to influence cutaneous wound healing. The authors previously published a case series investigating the effect of FW on
symptomatic abnormal skin scars (raised dermal scars [RDS]) using spectrophotometric intracutaneous analysis (SIAscopy). In addition, a human volunteer sequential biopsy study in acute cutaneous wounds was conducted, which demonstrated that FW increased
vascularity. The aim of this study was to evaluate the effectiveness
of FW on symptomatic RDS using full-field laser perfusion imaging
(FLPI) to assess changes in dermal blood flow. Methods. Eighteen
patients with RDS and long-term pain and pruritus participated.
Time points analyzed were day 0, weeks 1 and 2, and months 1 and
2. Symptoms were monitored using a subjective numerical rating
scale. Additionally, a Manchester Scar Scale and digital photography were used. Objective noninvasive measures captured quantitative data: SIAscopy to measure melanin, hemoglobin and collagen
levels, and FLPI to assess the dermal blood flow. Results. There
were statistically significant reductions in pain scores (from day 0
to month 1, P = 0.007) and pruritus scores (from day 0 to week 1,
P = 0.007; and day 0 to month 1, P = 0.002). The trend of melanin
levels demonstrated an increase from day 0 to week 1, hemoglobin
levels showed an increase from day 0 to week 2, and hemoglobin
flux increased from day 0 to week 2 (not statistically significant).
Conclusion. This report demonstrates that FW electrical stimulation
significantly reduces the symptoms of pain and pruritus in patients
with RDS. This unique treatment has the potential for management
of symptomatic skin scarring.
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WOUNDS 2013;25(8):212-224
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Sara Ud-Din, MSc1,2; Pamela Giddings Dip, HE3; James
Colthurst, FRCS3; Sigrid Whiteside, MSc2,4; Julie Morris, MSc2,4;
Ardeshir Bayat, PhD, MBBS, MRCS1,2
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Address correspondence to:
Ardeshir Bayat, PhD, MBBS, MRCS
Plastic and Reconstructive Surgery
Research Manchester Institute
of Biotechnology University of
Manchester
131 Princess Street Manchester
M1 7ND
[email protected]
Disclosure: Funding for this study
was provided in part by Fenzian Ltd.
Key words: electrical simulation, Fenzian wave, abnormal skin
scarring, raised dermal scarring, pain, pruritus, noninvasive devices
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Bayat et al
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digital photography, numerical rating scales, scar scales,
and spectrophotometric intracutaneous analysis, which
is a noninvasive device.27 The results showed this intervention reduced symptoms and scar scores significantly, and indicated that these positive effects warranted
further investigation. Furthermore, the authors have
conducted a human volunteer controlled trial, using a
temporal punch biopsy model to evaluate the effects of
FW on acute cutaneous wound healing. It was demonstrated through the use of full-field laser perfusion imaging (FLPI) that vascularity is increased with FW. The
histological results also showed that FW accelerated
healing by increasing angiogenesis and reducing inflammation.28 Therefore, it was postulated that it would be
beneficial to investigate if vascularity is affected in patients undergoing FW treatment for their symptomatic
RDS using FLPI, as this had not been evaluated in the
previous case series. The purpose of this study was to
explore these effects in an additional cohort of patients.
PL
IC
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ach year in the developed world, up to 100 million people develop skin scarring as a result of
burns, self-harm, and other injuries or trauma.1-3
Skin scarring presents a clinically challenging problem.
Patients with abnormal skin scars, particularly raised
dermal scars (RDS), which include hypertrophic and
keloid scars, often report considerable discomfort due
to the physical morbidity of pain, inflammation, and
pruritus.4 These scars can also impact a patients’ quality of life and their psychosocial symptoms including
anxiety and low self esteem.5-9
Many therapies are utilized in the management of
RDS, including steroid injections, pressure therapy, and
surgical interventions.10 However, these treatments can
be unsatisfactory, and if used alone, especially in the case
of keloid scars, can lead to recurrence. Recurrence rates
following surgical excision and steroid injections have
been reported to be as high as 50%.10,11 Thus, there is a
need for safe, alternative therapies that have a low side
effect profile with reduced risk of recurrence. Electrical
simulation (ES) is one therapy that has been used successfully in the past for treatment of RDS.12-18 Different
types of ES have been shown to have beneficial effects
on wound healing.12-24 Direct current (DC), which is a
unidirectional flow of charge toward the positive pole,
has been useful in treating chronic skin ulcers.19 Alternating current (AC), where the charge flow constantly
changes direction reversing the polarity, has been successfully used in managing diabetic and neuropathic
foot ulcers.20,21 Additionally, pulsed current, where the
flow of charged particles intermittently stops for a limited period of time, has been beneficial in enhancing the
healing of chronic wounds.22-24
A novel ES waveform that degenerates with time,
called the Fenzian wave (FW), has already been used in
the treatment of wound healing.25-28 A previous case review demonstrated the use of FW in improving a range
of symptoms, showing promise in the treatment of cutaneous injuries.25 A recent in vitro study also identified that FW had beneficial effects on skin and keloid
fibroblasts.26 Both types of fibroblasts were electrically
stimulated with alternating currents, as well as direct
current and FW. Fenzian wave was shown to decrease
collagen levels; therefore, it is considered to be a potentially useful method for reducing the rate of collagen formation in keloid scars.
The authors recently published a case series that investigated the effect of FW ES on symptomatic abnormal skin scars.27 This was evaluated through the use of
Methods
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Patients were recruited from October 2010 to June
2011 through the specialist scar service at the University Hospital of South Manchester NHS Foundation
Trust, in Manchester, England, UK. The patients were
provided with written and verbal information about
the FW treatment and were given the opportunity to
ask questions prior to treatment, during which time it
was also established if they fulfilled the inclusion and
exclusion criteria. Patients of any age, sex, and medical history were eligible. The inclusion criteria were:
any patient who had symptomatic scars that were
RDS only, including keloid or hypertrophic scars and
RDS of different causations, such as acne, surgery, and
trauma; patients who had scars that had not previously
responded to treatments for their symptoms, (eg, steroid injections or surgery); and those who requested
further noninvasive treatment. The exclusion criteria
were: patients who were taking medications such as
antibiotics or steroids as they are known to reduce the
electrical activity in the skin29; patients who were pregnant or planning to conceive; patients with implanted
electrical devices (ie, pacemaker, cochlear implant);
and patients with other types of scars.
Fenzian Wave Electrical Stimulation Device
The Fenzian treatment system (Fenzian Ltd, Hungerford, UK) is Conformité Européenne (CE) approved
and 510(k) registered with the United States Food and
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Intervention
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The treatment was performed by a single practitioner who was trained using a
protocol tailored to each patient.The treatment process is outlined in a flowchart
(Figure 1). The patients were treated while
sitting in a chair or lying down, whichever
was most appropriate to view the location of the scar. The device, due to this
biofeedback electrical mechanism, guides
the length of treatment. Furthermore, the
device is set at a strength that is comfortable for the patient. All patients gave written consent for photographs and noninvasive imaging to be carried out throughout
their treatment. Patients did not undergo
any other scar therapies for the duration of
their ES treatment. Patients were offered 2
treatments a week for the first month and
this was reduced over time according to
their symptom reduction.Additionally, they
attended a follow-up appointment with the
senior clinician at 4 months.
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Figure 1. A flowchart depicting the Fenzian wave electrical
treatment process.
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Drug Administration. The University Hospital of South
Manchester Trust Medical Engineering also approved
the system for use. This device is a low intensity transcutaneous electrical stimulation device that detects
changes in skin impedance using a microcurrent generator. The electrode is 45 mm x 22 mm in size, and impulses are applied of approximate duration of 1/600th
of a second and of 20-80V amplitude.
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Assessment Tools
Manchester Scar Scale. Digital photographs were obtained to monitor the appearance of the scar. The scars were also
clinically evaluated at each appointment
using the Manchester Scar Scale,30 which
assesses the color, contour, distortion, texture, and whether the scar has a matte or
shiny appearance. Each of these criteria
score from 1 to 4 and a combined total
score ranges from 5 to 18, with 18 being
the most severe.
Numerical Rating Scale. The patient’s
subjective rating of their pain and pruritus
stimulation
were obtained at each visit using the Numerical Rating Scale (NRS).A score of 0 indicates no pain or pruritus and a score of 10
indicates the worst pain or pruritus. It was also recorded
whether these symptoms were constant or intermittent.
Noninvasive imaging techniques were also used at various time points throughout the patients treatment on the
same scar site each time, using spectrophotometric intracutaneous analysis and FLPI.
Spectrophotometric intracutaneous analysis. Spectrophotometric intracutaneous analysis (SIAscopy)
Bayat et al
(Astron Clinica Ltd, Cambridge, UK) is a noninvasive
scanning technique that analyzes light reflected from
the skin.31 Numerical values for the pigmentary status—hemoglobin, melanin, and collagen—in the first 2
mm of the skin32 are provided for quantitative analysis.
The software provides high-resolution maps of various
components of the skin, such as the concentration and
location of melanin in the papillary dermis and epidermis, also the concentration of blood and collagen
in the papillary dermis.31 The light-based technology
probe, which is 11 mm in diameter, was placed on the
same scar site for each patient at each visit.
Full-field laser perfusion imaging. The measure of
blood flow in the cutaneous scar tissue is linked to the
vascularization present. Full-field laser perfusion imaging
(Speckle Contrast Imager-1,Moor Instruments Ltd,Axminster, UK) was used to obtain quantitative values for the
blood flow present in the scar at each visit. The FLPI was
positioned perpendicular at a set distance from the scar
site and the focus was adjusted to incorporate the specific scar area. Images were produced of the blood flow
in the microvessels in the surface layer of the tissue. Ten
consecutive images were obtained over a period of 10
seconds, and the average blood flow was calculated when
analyzing the images using the software (version 3.0).The
perfusion unit is expressed as ‘flux.’
Table 1. Summary of patient demographics.
Statistical Analysis
Table 2. Abnormal scar data information.
No. of patients
Total
Gender
Male
Female
White
Other
Fitzpatrick
Skin Type
I
II
III
IV
V
VI
Percent (%)
18
100.0
8
10
44.4
55.6
12
6
66.7
33.3
0
12
1
3
2
0
0
66.7
5.6
16.7
11.1
0
12
5
72.2
27.8
10
4
3
1
55.6
22.2
16.7
5.6
3
5
4
6
16.7
27.8
22.2
33.3
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Ethnicity
Frequency
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Demographics
I-III
IV-VI
No. of scars
1
2
3
Multiple
Age group
(years)
≤ 25
26-35
36-45
≥ 46
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Fitzpatrick
Skin Type
group
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O
N
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Trends were documented between demographic
characteristics using descriptive statistics. One scar
per subject was selected to be included in the statistical analysis. Each patient’s most problematic scar, with
the worst symptoms, was chosen to be analyzed. The
changes from day 0 to each time point were analyzed
separately using nonparametric summary statistics
and pairwise Wilcoxon signed-rank tests to assess differences in pain, pruritus, scar score, blood flow, melanin, hemoglobin, and collagen levels. All analyses were
performed using the statistical package SPSS version 15
(SPSS Inc, Chicago, IL) and a 1% significance level was
used for the P-values to adjust for multiple comparisons.
It was only feasible for the same person to conduct all
the treatments and assessments, and this possibly could
lead to bias. To minimize bias, independent statisticians
carried out all of the statistical analysis.
Results
Demographics. Demographic data is presented in Table 1. Nineteen patients were treated with FW. Combined,
Details
No.
Location
Sternum
Shoulder
Abdomen
Breast
Other
10
2
1
2
3
Cause
Trauma
Surgery
Acne
6
5
7
Age of scar
< 11 months
1-3 years
> 3 years
2
5
11
Type of scar
Keloid
Hypertrophic
14
4
Symptoms
Redness only
Pain and itch
Pain only
Itch only
2
15
0
1
Previous scar
excision
Yes
No
7
11
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Table 3. Number of Fenzian Wave electrical stimulation treatments patients received over the 2-month period
Week 1
N = 10
Week 2
N = 12
Month 1
N = 13
1.0
3.0
3.5
6.0
9.5
Minimum
1
2
2
3
4
Maximum
1
3
5
10
14
Table 4. Abnormal scar data information.
Day 0 pain score
Day 0 pruritus score
Percent (%)
2
7
5
4
11.1
38.9
27.8
22.2
0
1-3
4-6
7-10
Frequency
IC
Frequency
1
1
3
13
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Score Group
A
Median
Pain score *
Increase
Same
Decrease
Month 1
Increase
Same
Decrease
Month 2
Increase
Same
Decrease
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Pruritus score *
Frequency
Percent (%)
1
2
7
10.0
20.0
70.0
0
1
9
0
10.0
90.0
1
4
5
10.0
40.0
50.0
0
4
7
0
36.4
63.6
1
1
10
8.3
8.3
83.3
0
2
11
0
15.4
84.6
1
1
7
11.1
11.1
77.8
1
1
7
11.1
11.1
77.8
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Week 2
5.6
5.6
16.7
72.2
Percent (%)
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Increase
Same
Decrease
Percent (%)
Frequency
T
Week 1
Month 2
N = 10
TE
Day 0
N = 18
* Changes from day 0, excluding score of 0 on day 0
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patents had more than 28 symptomatic RDS which were
monitored; however, only 1 scar per patient—the most
symptomatic scar as identified by the patients during
the initial consultation—were included in the statistical
analysis. One patient was excluded from the analysis after opting to have surgical excision of their scar instead.
This resulted in a case series of 18 patients, with 18 scars
included in the statistical analysis. Patients’ mean age was
39 years, and ranged from 22-80 years.The modal Fitzpatrick Skin Type was II (66.7% of patients; fair skin, burns
easily, and tans poorly), and the majority of patients were
female (n = 10) and white (n = 12).
Presenting abnormal scars. Presenting abnormal
scars data is outlined in Table 2. The majority of patients presented with their symptomatic RDS being
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keloid (n = 14). The scars were predominantly due to
acne (n = 7); however, the cause of the scars also included trauma (n = 5) and surgery (n = 6). The area
most affected by the scarring was the sternum (n = 10),
with the majority of the scars being long-standing for
more than 3 years (n = 11).
Prior to commencing ES treatment, 15 patients
complained of both pain (defined as constant and persistent pain which had been present for more than 3
months) and pruritus (defined as a constant itch which
had persisted for ≥ 3 weeks); 1 patient complained of
only pruritus; none of the patients complained of only
pain; and 2 patients expressed they had no symptoms
except redness.The median baseline pruritus score was
4 (range 0-10) and median baseline pain score was 8
Bayat et al
Table 5. Symptomatic outcomes demonstrating pain scores significantly reduced from day 0 to month 1 and
pruritus scores showed statistically significant reductions from day 0 to week 1, and to month 1, respectively.
Week 1
Week 2
Month 1
Month 2
Median
Minimum
Maximum
N = 18
4.0
0
10
N = 10
3.5
0
10
N = 12
3.0
0
8
N = 13
3.0
0
9
N = 10
3.0
0
10
Median
Minimum
Maximum
P-value
N = 16
5.0
1
10
-
N = 10
3.5
0
10
0.091
N = 10
3.0
1
8
0.058
N = 12
3.0
0
9
0.007 ^
N=9
3.0
0
10
0.120
Median
Minimum
Maximum
N = 18
8.0
0
10
N = 10
4.0
0
10
N = 12
3.0
0
10
N = 13
5.0
0
9
N = 10
2.5
0
10
Median
Minimum
Maximum
P-value
N = 17
8.0
3
10
-
N = 11
3.0
2
10
0.016
N = 13
5.0
0
9
0.002 ^
N=9
3.0
0
10
0.030
Median
Minimum
Maximum
P-value
N = 18
14.0
6
16
-
N = 12
14.5
6
16
0.317
N = 13
14.0
12
16
> 0.999
N = 10
14.0
6
16
> 0.999
Manchester Scar
Score total
N = 10
4.0
0
10
0.007 ^
N = 10
14.5
12
16
0.317
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Pruritus score,
excluding
score 0 on day 0
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Pruritus score
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Pain score,
excluding
score of 0 on
day 0
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Pain score
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Day 0
T
P-values from paired Wilcoxon signed ranks tests vs day 0
^ Statistical significance at 1% level
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O
N
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(range 0-10). The median baseline score was 14 (range
6-16) using the modified Manchester Scar Scale. Additionally, a median of 10 (range 5-22) treatments were
performed on the 18 patients over 2 months (Table 3).
As this data was for a case series and not a structured patient trial, patient visits occurred at various
time points, rather than at planned time intervals. All
patients had a treatment on day 0; however the other
analysis time points were chosen to use the most available data at times similar to those in previous publications. The time points chosen were week 1 (7 days ± 1
day following the first treatment), week 2 (14 days ± 1
day following the first treatment), month 1 (28 days ±
2 days following the first treatment) and month 2 (56
days ± 7 days following the first treatment ). For multiple available measurements within a time window, the
earliest and closest day to the nominal time was used.
The same day was chosen for all parameters. Patients
were reviewed at month 6, although only patient data
at the chosen time points above were included in the
summaries and analyses due to decreased number of
patients returning at month 6.
Analysis of Symptomatic Outcomes
Table 4 shows the patient-reported symptomatic scores
and the changes from baseline to each time point. Fifteen
patients commenced with pain prior to treatment. Ten of
these were included in the week 1 analysis and 7 (70%)
reported a decrease in pain at week 1. One patient (10%)
experienced an exacerbation of their pain symptoms following initial treatment. Sixteen patients reported pruritus
symptoms prior to treatment, and of the 10 recorded, 9
(90%) reported an improvement at week 1. No patients
had an increase in pruritus symptoms at this point.
At month 1, 10 (83.3%) of the patients who reported
pain symptoms initially experienced an improvement.
Eleven (84.6%) of the patients who initially reported
pruritus symptoms found their symptom decreased. At
this time point, the median number of treatments was 6
(range of 3-10).
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Figure 2.
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patients reported no pruritus symptoms; all of these
patients had a considerable reduction in pruritis after
a median of 9.5 treatments (range of 4-14 treatments).
Patients were followed up to month 6 to assess if
any changes had been sustained, although this data
was not included in the statistical analysis due to a
decreased number of patients. All patients who were
reviewed stated their symptoms remained reduced or
had completely resolved.
Pain scores showed statistically significant reductions from day 0 to month 1 at the adjusted 1% significance level (P = 0.007). However, there were no statistically significant changes in pain scores from day 0 to
weeks 1 and 2, or month 2, respectively (Table 5).
Pruritus scores showed statistically significant reductions from day 0 to week 1 (P = 0.007) and from
day 0 to month 1 (P = 0.002), respectively, at the adjusted 1% significance level. However, there were no
statistically significant changes in pruritus scores from
day 0 to week 2 or from day 0 to month 2, respectively
(Table 5).
Manchester Scar Scale outcomes.Three patients
noted some reduction in scar color by the completion of treatment compared to baseline (Figure 2a),
although, there were no significant changes noted in
the Manchester Scar Scale throughout the duration of
treatment. The scar score total showed no statistically
significant changes from day 0 to weeks 1 and 2, or to
months 1 and 2, respectively (Table 5).
SIAscopy analysis. SIAscopy was used to capture
data to identify any changes in patterns from baseline
to the other time points (Figure 2). Trends in melanin
levels demonstrated an increase from day 0 to week
1 (Figure 3a), hemoglobin levels showed an increase
from day 0 to week 2 (Figure 3b), and collagen levels
remained approximately the same throughout (Figure
3c). Although, there were no statistically significant
changes observed in melanin, hemoglobin, or collagen
levels from day 0 to weeks 1 and 2, or to months 1 and
2 (Table 6).
Full-field laser perfusion imaging analysis. Full
field laser perfusion imaging was used to monitor the
blood flow (flux) across the scars and observe any
changes from baseline to the other time points (Figure
4). The trend in hemoglobin flux increased from day 0
to week 2 (Figure 3d), although, hemoglobin flux mean
levels showed no statistically significant changes.
Whilst undergoing the therapy, 12 patients experienced tiredness post-treatment which lasted for ap-
a) Images of a 23-year-old male with a facial hypertrophic scar that caused by acne. The images show a reduction in scar color from day 0 to month 2 following completion of Fenzian wave electrical stimulation treatment.
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b) Spectrophotometric Intracutaneous Analysis (SIAscopy) images displaying scar color that has reduced from
day 0 to month 2.
c) SIAscopy images demonstrating a reduction in melanin levels from day 0 to month 2.
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d) SIAscopy images showing a reduction in hemoglobin
levels over the 2-month period.
e) SIAscopy images displaying the collagen levels.
At month 2, 7 (77.8%) patients reported no pain,
therefore resolution of this symptom was considered
achieved at this time point. Also at month 2, 8 (47%)
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Figure 3.
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a.b.
a) The graph shows the trend of median melanin levels which increase from day 0 to week 1.
b) The graph shows the trend of median hemoglobin levels that increases from day 0 to week 2 with a subsequent reduction thereafter.
c) The graph shows the trend of median collagen levels that showed no overall changes.
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d) The graph shows the trend of median hemoglobin flux levels demonstrating an increasing trend from day 0 to week 2,
which was similar to that of hemoglobin levels.
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proximately 2 hours, and 5 patients reported a tingling
sensation at the treatment site which they stated was
not painful and only lasted for approximately 1 hour
after treatment. Four patients noted that, following the
first treatment, their symptoms subsided over a period
of 4 days but began to return approximately 1 week
post-treatment, although not as intensely as at baseline.
No adverse side effects were reported.
Discussion
Electrical stimulation in the form of FW showed
reduction of pain and pruritus scores from baseline
to the completion of treatment in symptomatic skin
scars. Pain and pruritus symptom scores were significantly reduced in all patients from baseline to 1 month
following the first treatment. These results were
based on the patients’ subjective numerical rating
Vol. 25, No. 8 August 2013
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Table 6. Summary of results for changes in melanin, hemoglobin, collagen, and hemoglobin flux (or blood flow).
Week 1
Week 2
Month 1
Month 2
Median
Minimum
Maximum
P-value
N = 18
268.18
-145.0
842.9
-
N=9
309.21
210.6
843.0
0.214
N=5
297.02
144.3
405.4
0.999
N=5
301.39
176.7
349.2
0.893
N=6
291.43
120.2
842.9
0.028
Median
Minimum
Maximum
P-value
N = 18
165.96
0.4
510.2
-
N=9
150.21
0.0
223.7
0.859
N=5
200.56
107.8
213.1
0.273
N=5
156.80
121.3
213.8
0.686
N=6
163.19
0.0
214.4
0.249
Median
Minimum
Maximum
P-value
N = 18
184.93
108.2
987.7
-
N=9
197.15
127.57
409.82
0.086
N=5
173.36
122.0
249.1
0.999
N=5
160.44
111.2
172.8
0.138
N=6
184.25
138.2
223.1
0.028
Median
Minimum
Maximum
p-value
N = 11
221.85
81.6
949.4
-
N=2
475.39
357.8
592.9
-
N=3
276.39
89.5
516.4
-
N=3
249.46
167.6
327.1
-
Collagen
N=6
192.46
67.0
250.4
0.600
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Flux
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Hemoglobin
PL
Melanin
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Day 0
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P-values from paired Wilcoxon signed ranks tests vs day 0
^ Statistical significance at 1% level
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O
N
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scale scores, which are clinically valid; in order to be
classed as clinically significant, a reduction of 2 points
on the scale was necessary.33 The use of the NRS to
assess symptoms has been widely recognized.33-35 Recently, Phan et al24 evaluated the validity and reliability
of various subjective scales used for itch assessment
and found the NRS to be highly reliable with concurrent validity. Hjermstad et al35 also found the use of
the NRS to be applicable in most settings for the assessment of pain intensity. Patients were reviewed 6
months post-treatment to ascertain if their symptoms
remained resolved. All patients expressed they did not
have recurrence of their symptoms of pain or pruritus.
However, it would be beneficial to conduct additional
follow-up after 1 year to assess if these changes had
been sustained.
Forty-five percent (45%) of patients responded to
treatment and had resolution of their symptoms within
1 month of commencing treatment. The authors noted
the remainder of the cohort’s symptoms were reduced
by the 2-month period. This longer time scale may be
due to a heterogenous cohort of patients that included
varying ages, location of scars, age of scars, and type
of scars. Interestingly, the sample group consisted of a
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majority of patients who had long-standing scars with
persistent symptoms for many years. These symptoms
took longer to resolve than patients with more recent
scars. It was also noted that the length of time pain
symptoms took to reduce varied according to the age
of the patients. Additionally, the more elderly patients’
symptoms required longer to subside than younger
patients’ symptoms. Furthermore, the location of the
RDS was a contributing factor in how quickly patients
responded to treatment. Patients with long-standing
sternal scars found their symptoms took a more extended time to diminish compared to patients with
scars in less stress-prone anatomical locations such as
the breast or abdomen. There were no physical scar
changes noted indicating a need for longer follow-up
as it is thought that the device may target the problematic symptoms first before the appearance of the scar.
The authors used objective, noninvasive devices to
quantify the effects of FW on symptomatic abnormal
skin scarring.These devices measured the hemoglobin,
collagen, and melanin levels, as well as the blood flow
present at the scar sites. There were trends in melanin
levels demonstrating an increase from day 0 to week
1, and hemoglobin levels and blood flow showed an
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increase from day 0 to week 2. The reduction in pain
and pruritus was noted in keloid and hypertrophic
scars which often tend to be raised and red, therefore
indicating reduced inflammation. The trends indicated
an increase in hemoglobin and blood flow up to the
2 following initial treatment, which corroborates this.
However, histological analysis would be beneficial to
investigate these findings further.
While searching the literature, the authors noted a
trend in increasing blood flow up to week 2 during
FW treatment. Previous research has shown that ES
improves blood flow and wound tensile strength.36-38
These studies used FLPI to measure this effect, which
the authors chose to do in the current case series, and
demonstrated a significant increase in blood flow following treatment. A previous study also found that low
frequency ES increases blood flow to a wound and vasodilation occurs through the C fibers.39
The authors found a trend of increasing hemoglobin up to 2 weeks following initial treatment with FW
with a subsequent decrease thereafter. The increase
in hemoglobin could be due to a proinflammatory response that stimulates the tissue.40,41 It is thought that
substance P, a neuropeptide, controls pain through the
C fibers42 and can be a factor in increasing the neuroinflammatory response in raised scars due to decreased
endopeptidase.43 It has also been assumed that pruritus is signaled by a subpopulation of polymodal nociceptive C fibers.44 The significant reductions in pain
and pruritus symptom scores suggest a decrease in inflammation at the 1-month period following the initial
treatment with FW. This theory corresponds with the
decreasing trend seen in hemoglobin levels and blood
flow in the 2-week period after FW treatment. The
authors have previously shown that FW accelerates
acute cutaneous wound healing evidenced by reduced
inflammation, enhanced angiogenesis, and advancing
the remodeling phase.28 Furthermore, their findings
show a statistically significant increase in blood flow
at day 14 which corroborates with the trend seen
in this case series. The lack of significance using the
noninvasive devices may have been due to a reduced
number of data at the later stages of treatment. Some
patients were not returning at the predetermined specific time points due to work commitments and travel
problems; therefore, a larger scale study would be beneficial in order to account for this.
Hemoglobin, provides red coloration to human skin
via the vascular network of microcapillaries, and mela-
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Bayat et al
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Figure 4. The Full-field laser perfusion imager was used
to monitor the blood flow across the scars and observe
any changes from baseline to the other time points.
This is a 42-year-old female with a keloid scar on the
breast. The images generated show more intense color
at week 2 indicating higher blood flow with a subsequent reduction to month 2 by the end of treatment.
nin provides varying degrees of brown coloration at
the surface of the skin.45 An increase in melanin was
noted at week 1 after FW treatment commenced, as
well as a high hemoglobin level when increased pigmentation was noted early in the treatment process.
Interestingly, collagen levels remained approximately the same throughout treatment. The majority
of the scars were keloid and hypertrophic, which have
higher amounts of collagen.46,47 In a previous in vitro
study, the authors showed that FW suppressed excessive collagen I formation in keloid disease. Histological
analysis would be beneficial in this study to generate
more information.
There were no significant changes in objective scar
scores using the Manchester Scar Scale. Nevertheless,
the previous case report using FW on symptomatic
abnormal skin scars showed significant reductions in
scar scores in particular, and a reduction in scar color
over the 2-month period, with the greatest reductions
in hypertrophic and surgical scars.27 In 3 of the patients, the authors noted a reduction in scar redness;
however, a longer follow-up and increased number of
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Conclusion
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All patients with symptomatic RDS who were treated with FW demonstrated a significant reduction of
symptoms of pain and pruritus. Patients with keloid
and hypertrophic scars in less stress-prone anatomical
locations had the greatest reduction in symptoms and
younger patients with new scars experienced earlier
symptom resolution. This treatment can be beneficial
as it may negate the need for long-term pain medications, and has the potential for management of symptomatic skin scarring.
Previous Presentation
This paper was previously presented at: Symposium
of Advanced Wound Care/Wound Healing Society Meeting; April 19-22, 2012; Atlanta, GA.
PL
treatments may have been beneficial in order to investigate these findings further.
This particular study was based on a case series of
all patients with symptomatic raised dermal scarring
who were treated with ES. Treatment was provided for
consecutive cases and was not preplanned. The common denominator with all of these cases was the presence of a symptomatic raised dermal scar, which appeared to be responding to the application of ES. This
study provides preliminary data obtained with objective noninvasive devices and subjective assessment
tools. However, in order to expand on these results,
a larger controlled trial would be beneficial, including a control group with a placebo device to further
investigate the effects of this treatment. There was no
data obtained using the objective tools on normal skin
over time; however, this could be incorporated into a
future study. The use of objective assessment tools in
this study reduced the possibility of bias, although it
was only feasible for the same person to conduct all
the treatments and assessments, and this may have led
to bias. To minimize this, all of the statistical analysis
was carried out by an independent statistician who is
named as a coauthor. A limitation was that only 1 scar
per patient could be included in the statistical analysis.
Furthermore, it would be pertinent to assess whether
response to treatment is affected by how often the individual receives treatment, as well as the age of the
scar. In addition, a longer-term follow-up, plus histological evidence pre- and post-therapy, may provide further
information as to the utility of FW in the treatment of
symptomatic abnormal skin scars.
In this case series, the authors have shown significant reduction in symptom scores. The therapeutic effect of this treatment is measured by relying on the
patients’ reports and it has been argued that subjective
measurements can lead to numerous variables that can
make evaluation difficult.48 In addition, it is well known
that any procedure may generate placebo effects.49 It
has been suggested that a placebo has an analgesic effect; therefore, it is important to determine whether
the ES treatment has an effect equal to or greater than
that of the placebo.48 However, the effects found in this
case series cannot be readily ascribed to placebo effects since they were sustained for a long period of
time even when the treatments had ceased. Additionally, the studies the authors have previously conducted
both clinically and in vitro have demonstrated statistically significant positive effects following FW.26-28,50
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