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International Archives of Medicine
Section: Physical Medicine & Rehabilitation
ISSN: 1755-7682
International
Medical Society
http://imedicalsociety.org
1
2018
Vol. 11 No. 14
doi: 10.3823/2555
© Creative Commons Attribution 4.0 International (CC BY 4.0) License This article is available at: www.intarchmed.com and www.medbrary.com
Abstract
Introduction: Fibrocystic breast disease is the most widespread di-
sorder in women during their phase of sexual maturity. Deep oscilla-
tion (DO) therapy has been used on patients who have undergone
an operation for breast cancer as a special form of manual lymphatic
drainage.
Method: Experimental, prospective case-control studies were con-
ducted in 401 women diagnosed with fibrocystic breast disease. The
sample was selected at random and was divided into three groups, a
study group and two control groups.
Results: Pain was reduced in the three therapies applied. This was
statistically significant in the study group. The sonography study pre-
sented a predominance of its fibrous form. Upon completion of the
treatment a resolution of the fibrosis was observed in the study group.
The women were using their bra in an incorrect manner.
Conclusions: Pain was reduced in the three therapies applied. In the
study group this reduction was statistically significant. It is possible to
verify the magnitude of the resonant vibration in the connective tissue
from surface to deep layers by viewing the effect of the deep osci-
llations through the use of diagnostic ultrasound. The most frequent
sonographic finding was fibrosis. Deep oscillation therapy produces
a tissue-relaxing, moderate vasoconstriction effect, favours local oe-
dema reabsorption and fibrosis reduction. A factor that may affect
breast pain is incorrect bra use. The majority of women studied were
using their bra incorrectly.
The Effect of Deep Oscillation Therapy in Fibrocystic
Breast Disease. A Randomized Controlled Clinical Trial
ORIGINAL
Solangel Hernández Tápanes1,
Marilyn de Jesús Socas Fernández1, Yinet Iturralde2,
Addiel Suáres Fernández3
1  Specialist in Physical Medicine
Rehabilitation. University Clinic Luis de
la Puente Uceda. Havana Cuba.
2  Specialist in Gynecology and Obstetrics.
University Clinic. Luis de la Puente
Uceda. Havana Cuba.
3  Physical Therapist University Clinic Luis
de la Puente Uceda. Havana Cuba.
Contact information:
Solangel Hernandez.
Address: Specialist in Physical Medicine
Rehabilitation. University Clinic Luis de la
Puente Uceda. Havana Cuba.
solangel@portalamlar.org
Keywords
Deep Oscillations; Fibrocystic
Breast Disease; Benign Breast
Disease; Mammary Dysplasia.
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
This article is available at: www.intarchmed.com and www.medbrary.com2
Introduction
Fibrocystic breast disease (CIE 10 N 64.0) is the
most widespread disorder in women during their
phase of sexual maturity, with or without clinical
manifestations. The breast is one of the target or-
gans of ovarian hormones; disruptions in the ova-
rian cycle lead to fibrocystic disease, which cau-
ses considerable discomfort in a high number of
women between the ages of 35 and 50 [1]. Its
clinical-histopathological alterations are produced
by a possible oestrogen-progesterone hormonal
imbalance, which induces persistent changes in the
ductal-lobular unit, both in the epithelial and in
the conjunctival component. It is characterised by
inflammatory events and proliferative histological
changes that may be cysts, apocrine metaplasia,
conjunctival hyperplasia, ductal ectasia, epithelial
hyperplasia [2-4].
Generally a painful breast complaint indicates a
functional disorder or a benign illness; however,
breast cancer can present itself with pain, and so
in the presence of any kind of breast pain it is re-
commended to pay special attention [5-7].
Fibrocystic breast disease accounts for 54%
of breast diseases and 70% of benign lesions; it
affects one of every two women of childbearing
age although it may appear in any stage of life.
In Cuba it represents 49.8% of all breast disea-
se and thus constitutes an important problem in
women’s health. Many do not consider it a disease
but rather an unpleasant condition for women,
one with which they have to learn to live, given
that it is a process that occurs clinically and histo-
logically in between 50% and 90% of women [8].
The term benign breast condition includes:
- Fibrocystic disease (also called mammary dys-
plasia, fibrocystic condition, fibrocystic chan-
ges, among others).
- Benign tumours.
- Inflammations.
Fibrocystic changes can be grouped into 3 histo-
pathological forms:
- Fibrous hyperplasia, with a predominance of
conjunctival tissue.
- Cystic hyperplasia, with a predominance of
variable-size cysts.
- Sclerosing adenosis, when the following asso-
ciate: increase of small lobes, intracanalicular lo-
bular fibrosis and variable degrees of epithelial
hyperplasia [9].
In fibrocystic disease micro-cysts predominate.
They are more frequent in the 40 to 50 age range
(42%). Pain and nodules are almost constant symp-
toms; nipple discharge is infrequent. Pain drives
the woman to consult a doctor, although in some
cases it is nodularity that does this, which can be
unilateral or bilateral; its intensity increases as the
menstrual cycle progresses and is relieved or disap-
pears with the onset of menstruation. A differen-
tial diagnosis should be made with other types of
breast pain in order to rule out selective dyspla-
sias or cancer. It becomes important to make the
differential diagnosis with malignant neoplasms
that may be overestimated in the premenstrual
phase and lead to errors in interpretation; someti-
mes they are identical to carcinoma. Between 5%
and 10% of cases are due to extramammary cau-
ses: ribcage osteochondritis, intercostal neuralgia,
stress-related muscle pain (pectoralis major mus-
cle, latissimus dorsi), mammary pain due to spinal
root syndrome, cervical radiculopathy, intramam-
mary adenitis and premenstrual syndrome, among
others.
In all cases it is important to physically examine
the breasts and the underarm region, complemen-
ted with sonography, mammogram and pap smear
[10-12]. A sonogram is the most useful study, as it
defines whether the lesions are cystic or solid; it is
also required as a complement to a mammogram
in lesions of an undefined nature.
A biopsy or fine-needle aspirate cytology is an
innocuous method and in doubtful cases provides
a cytological diagnosis, particularly in complex no-
dules or masses that are non-painful or discretely
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
© Creative Commons Attribution 4.0 International (CC BY 4.0) License 3
painful as well as in lesions that undergo little or
no modification in the fluctuations of the menstrual
cycle. It also permits the evacuation of septated
cysts, which are frequent in the involutive phase of
the process.
Pharmacological treatment for fibrocystic breast
disease is heterogeneous. It includes therapies with:
danazol, tamoxifen, ormeloxifene, oral analgesic
and anti-inflammatory treatments, local nonste-
roidal anti-inflammatory treatment, progesterone,
ginseng, linseed, phytoestrogens (isoflavones), eve-
ning primrose oil, vitamin B6, vitamin E [13-17].
Anti-inflammatory treatment relieve pain and
swelling in general without modifying the course
of the illness. Their effect depends on the inhibition
intensity of prostaglandin synthesis. The majority of
adverse effects also depend on this action.
Treatment should be aimed at combating the cau-
ses that give rise to it, with three basic objectives:
- Dietary and hygienic measures,
- Invasive treatment (puncturing cysts, surgical
excision of nodes, complex cystic lesions or
their residual capsule, etc.)
- Provide all possible information, modify lifes-
tyles and promote the systematic practice of
breast self-examination.
Stress is a contributing or resulting factor in pain
and controlling it is an integral part of treatment
through evaluation and the use of psychological
support techniques, complemented with educating
the patient and providing her with information.
Another critical factor to take into account is the
right postural treatment of the cervico-dorsal spinal
column and the correct use of the bra. The use of
a well-fitting breast brace that provides full support
should be considered in achieving a reduction of
cyclical and non-cyclical breast pain. Vitamins E and
B6 are often prescribed in patients with fibrocystic
breast disease. Revised studies conclude that the
consumption of vitamin E has not demonstrated
any evidence for consideration in the treatment of
breast pain, and for the consumption of vitamin
B6 there is insufficient evidence to demonstrate its
effectiveness.
There is little research into breast pain in regard to
the administration of pain relief such as acetamino-
phen or nonsteroidal anti-inflammatory treatments.
In contrast to the above-mentioned conventional
therapies, which act on the neuromuscular system,
treatment with electrotherapy in deep oscillation
therapy acts on the conjunctival tissue through
weak electrostatic charges [18-19].
This therapy has been used in the treatment of
patients who have undergone an operation for
breast cancer, as a special form of manual lympha-
tic drainage that has made it possible to start using
a prophylactic procedure right from the first day of
the postoperative period thanks to the early rechan-
neling of the lymphatic drainage tracts in order to
prevent both the formation of lymphedemas and
painful shoulder syndrome. This therapy has been
shown to be efficacious in diminishing the secon-
dary effects of radiotherapy [20, 21].
For these reasons it was decided to conduct a
study of patients diagnosed with fibrocystic breast
disease treated with deep oscillation therapy, com-
paring their evolution with those treated in a con-
ventional manner.
Method
Experimental, prospective case-control research was
conducted in 401 women diagnosed with fibro-
cystic breast disease in the period from December
2009 to December 2014. The universe comprised
female patients between 20 and 50 years of age
who attended the specialised breast disease clinic.
The sample was selected randomly and was divided
into three groups. Approved by the Ethics Com-
mittee of the University Polyclinic Luis de la Puente
Uceda. Register number 01245
- Group I or study group: 106 patients who were
given deep oscillation therapy (with a Hivamat
200® device by PHYSIOMED®) based on the
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
This article is available at: www.intarchmed.com and www.medbrary.com4
following parameters: frequency, intensity, vi-
bration and mode. The treatment plan cove-
red 3 weeks (15 sessions), a daily session from
monday to friday.
- Group II: 146 patients who were treated with
ibuprofen (nonsteroidal anti-inflammatory
treatment), 1 400-mg tablet every 12 hours
for three weeks.
- Group III: 149 patients who were treated with
medroxi-progesterone, 1 25-mg ampoule ad-
ministered intramuscularly from the second half
of the menstrual cycle onwards and on alterna-
te days, for a total dosage of 150 mg.
Objective
General
To evaluate the efficacy of deep oscillation therapy
in fibrocystic breast disease.
Specific
- To assess the effect of the treatment on the
evolution of pain.
- To describe the effect of the treatment accor-
ding to sonogram evolution.
- To determine incorrect bra use.
Criteria for the selection of the sample
For inclusion
- Patients with fibrocystic breast disease aged
between 20 and 50 years.
- Patients who were given prior information on
the characteristics of the study and accepted
the conditions.
For exclusion
- Patients with decompensated cardiovascular
conditions, pacemakers in the treatment area.
- Patients with infectious skin conditions in the
region being treated.
- Patients with nipple discharge.
- Malignant diseases.
- Pregnancy.
- Sensitivity to electric fields.
Exit criteria
- Patients who stopped treatment after they
were included in the study.
Study phases
- Diagnostic phase
- Treatment phase
- Evaluation phase
Diagnostic phase
After the sample had been selected and formed
after having confirmed the diagnosis of fibrocystic
breast disease, the clinical history was drawn up,
which included initial assessment, questioning, phy-
sical examination and diagnosis as well as a sono-
gram study and BAFF puncture where appropriate.
Treatment phase
The patients from the study group were given deep
oscillation therapy (Hivamat 200® device) under the
following parameters: frequency, intensity, vibration
(mode), time and sessions.
- First time: 5 min, frequency of 160 Hz, 50%
intensity, vibration (mode) 2. This plan succee-
ded in dissolving the fibrosis and relieved pain.
- Second time: 3 min, frequency of 60 Hz, 50%
intensity, vibration (mode) 2. This plan succee-
ded in stimulating lymphatic drainage and re-
ducing breast congestion.
- Third time: 4 min, frequency of 15 Hz, 50%
intensity, vibration (mode) 2. This plan succee-
ded in increasing interstitial liquid flow and im-
proving the release of adjacent muscular fascia.
Total programme time: 12 minutes (for each
breast).
Procedure
Patient in a supine position with the hand corres-
ponding to the treated breast placed underneath
the nape, devoid of clothing; with the use of the
5-centimetre manual applicator, at the level of the
affected breast (s), in a clockwise direction, during
12 min. (Figure 1)
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
© Creative Commons Attribution 4.0 International (CC BY 4.0) License 5
Evaluation phase
When the rehabilitation treatment sessions were
completed, and by means of questioning, physical
examination and evolutionary sonogram study, we
checked for persistence of symptoms and sonogram
patterns. We proceeded likewise with those who
received conventional treatment.
Visual analogue scale (VAS) for pain severity:
On the continuous line, the patient marks the de-
gree of painful sensation between both ends, with
the rating from 0 to 10 indicated on the back. The
scale was subdivided to group it into:
- 0 No pain
- 1-3 slight pain
- 4-7 moderate pain
- 8-10 severe pain
The principal advantage is that it does not require
verbal or reading abilities and is sufficiently versa-
tile for using it in different situations. Thanks to its
validity, reliability and capacity to reflect changes
in pain intensity, it is one of the most widely used
scales.
A database and clinical histories were created
with the initial assessment, questioning, physical
examination, diagnosis, BAFF puncture and sono-
gram study.
Experimental procedure
Conditions of the device
German-made HIVAMAT 200® devices by PHYSIO-
MED® were utilised, with the use of the 5-centime-
tre manual applicator and suitable contact between
patient and manual applicator. Talcum powder was
used as a vehicle between the membrane of the
manual applicator and the patient’s skin.
Search for information
The search strategy for conducting the research
was developed over the period between Decem-
ber 2009 and January 2013. Searches were made
in online databases: EBSCO, LILACS, Medline and
Cochrane Library, supported by the EndNote 7 per-
sonal database manager. The MeSH (Medical Subject
Headings) terms: mammary dysplasia, fibrocystic
breast disease. We reviewed reference books by
relevant authors on oncology, surgery and gynaeco-
logy and obstetrics, pharmacology, physical thera-
peutic agents and specialised magazines. The levels
of evidence and degrees of recommendation were
hierarchically based on the classification system of
the Agency for Healthcare Research and Quality.
Statistical analysis
We used descriptive statistics of the data with sum-
mary indicators of absolute frequency (No) and rela-
tive frequency (%) in individuals, depending on the
category described.
As a statistical test, to conduct corroborating
treatment evolution according to the above-men-
tioned pain scales and sonogram results, we used
the sign test. For hypothesis corroboration we set
p0,05. The statistical packages used for analysis
were Stagraphic plus and NCSS-PASS-GESS for
Windows. The results were recorded on tables.
All ethical aspects of biomedical research were
met and guarantees were provided that there would
be no conflict of interest with PHYSIOMED®, the
company that produces the deep oscillation devices.
Figure 1: Treatment method whith deep oscillation
therapy in fibrocystic breast disease.
© Hernandez Tápanes Solangel. MD.
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
This article is available at: www.intarchmed.com and www.medbrary.com6
Results
Table 1 shows a predominance of ages between 31
and 40 years in the distribution by age: in Group I
with 64 patients for 60.4%, Group II with 86 pa-
tients for 58.9% and Group III with 95 patients
for 63.8% of the members of these groups. In re-
gard to the presence of toxic habits in the patients
studied, the most frequent one to be evinced was
coffee ingestion in 30.2% of patients and 23.7%
with a smoking habit, which was significant in both
identified factors. There were no statistically signifi-
cant differences between the groups.
Table 2 shows the use of contraceptives in the
studied groups, where 34.7% of patients used oral
contraceptives and 11.5% injectable contraceptives,
while 53.9% used no contraceptive hormones at all.
There were no significant differences between the
groups (p=0.67).
Pain assessment is presented in Table 3, where
the data gathered at the end of the treatment show
that 63.2% of patients in Group I had no pain,
nor did 24.6% of patients in Group II nor 21.5%
of patients in Group III, with significant statistical
differences in pain relief between the 3 therapies
(p=0.01). In the study group, at the end of the
treatment no patient had any pain of moderate or
severe intensity.
A sign test was conducted to check the differen-
ces in scores before and after treatment. The study
group revealed significant differences between sco-
res for pain before and after treatment for p≤0.04
(Z=-6.161; p=0.00).
When comparing the group treated with deep
oscillations with the control groups with pharmaco-
logical treatment, statistically significant differences
were found between the results of the scores repor-
ted for the pain scale before and after treatment,
for p≤0.05 (Z=-1.136; p=0.01). Based on these data,
it is possible to state that there are statistically signi-
ficant differences in the evolution of pain in patients
treated with deep oscillations when compared to
those who received pharmacological treatment.
Table 1. Distribution by age and toxic habits.
Groups Total
Ages
Coffee Tobacco
20-30 31-40 41-50
Total % Total % Total % Total % Total %
I 106 25 23.6 64 60.4 17 16.0 32 30.2 22 20.8
II 146 33 22.6 86 58.9 27 18.5 46 31.5 29 19.9
III 149 30 20.1 95 63.8 24 16.1 43 28.8 44 29.5
Total 401 88 22.0 245 61.0 68 17.0 121 30.2 95 23.7
Source: Survey x2=0.98 p=0.81 x2=1.72 p=0.97.
Table 2. Use of contraceptives.
Groups Total
Oral
contraceptives
Injectable
contraceptives
No
contraceptives
No % No % No %
I 106 36 34.0 12 11.3 58 54.7
II 146 47 32.2 17 11.6 82 56.2
III 149 56 37.6 17 11.4 76 51.0
Total 401 139 34.7 46 11.5 216 53.9
Source: Survey x2=2.86 p=0.67.
Table 3. Presence of pain according to verbal nume-
rical scale, by therapeutic plan at the start
and end of the treatment.
Groups
Start End
No
Pain
Slight Moderate Severe
No
Pain
Light Moderate Severe
I 0 30.2 56.7 14.2 63.2 36.8 0 0
II 0 34.2 53.4 12.3 24.6 46.6 26.0 2.7
III 0 32.9 52.3 14.8 21.5 43.0 25.5 10.1
Total 0 32.7 53.6 13.7 33.7 42.6 18.9 4.7
Source: Survey x2=0.98 p=0.80 x2=1.72 p=0.01.
Table 4. Sonogram findings by therapeutic plan at
the start and end of the treatment.
Sonogram
findings
Before After
GI GII GIII GI GII GIII
Fibrosis 75.5 72.0 73.8 17.5 67.1 67.1
Adenosis 15.1 21.2 13.0 11.3 17.8 10.7
Cyst 9.4 6.8 13.4 5.7 10.3 12.7
Total 0 32.7 53.6 13.7 33.7 42.6
Source: Survey x2==1.52 p=0.05.
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
© Creative Commons Attribution 4.0 International (CC BY 4.0) License 7
Table 4 shows the results of the sonogram study
conducted with patients before and after treatment.
The initial assessment showed a predominance of its
fibrous form (78.5%), followed by adenosis (16.4%)
and cystic form (10.0%). The fibrosis represented
75.5% in group I, 72.0% in group II and 73.8%
in group III, similar figures to a study conducted
on 1,551 patients in which fibrocystic disease in
its fibrous form prevailed. Upon completion of the
treatment, statistically significant changes were ob-
served in the resolution of the fibrosis in group I. In
groups II and III, while the number of patients with
fibrosis diminished, this reduction was not statisti-
cally significant.
During the physical examination appropriate bra
use was explored in regard to breast size in the
401 patients studied. Of these, 320 women, 70.1%,
were using the bra incorrectly, and of these 52.4%
the cup size was smaller than the breast size.
Discussion
Behaviour relating to age, toxic habits and use of
contraceptives in this study allows us to determine
the resemblance of the groups and the diminution
in bias in their comparison. These variables are pre-
sented separately, but we can announce that there
are no statistically significant differences in these
variables in the different groups, which speaks in
favour of comparing them.
In regard to age, we observed that fibrocystic
disease is more frequent after the age of 30. Some
papers record that it is more frequent between the
ages of 25 and 40 and others between 40 and
50, a phase which coincides with sexual maturity
and consequently frequent hormonal disorders [1,
8, 22]. Table 1 shows that of a total of 401 patients,
61.0% were aged between 31 and 40 years and
only 17.0% between 41 and 50.
In regard to the presence of toxic habits in the
patients studied, there were no statistically signifi-
cant differences between the groups. Coffee drin-
king was a habit among 30.2% of patients and
smoking among 23.7%. Data similar to those found
in the literature we consulted, based on non-en-
docrine theories, are supported by a biochemical
basis from observing excessive quantities of AMPc
in breast tissue owing to excessive consumption of
methylxanthines, which are abundant in drinks such
as tea, coffee, chocolate, colas, alcoholic bevera-
ges, as well as the harmful effect of nicotine, which
would be the most likely direct cause [23, 24]. The
consumption of tea, chocolate, cola or alcoholic be-
verages was not significant.
In relation to the use of contraceptives, no sta-
tistically significant differences were found between
the groups. 34.7% used oral and 11.5% injectable
contraceptives. Revised studies consider that the use
of contraceptives can trigger crises, while others
hold that it bears no relation at all. In this study, in
a total of 34.7% of women the disease was asso-
ciated with the use of oral contraceptives [25, 26].
The presence of breast pain or mastodynia is
the most persistent syndrome cited by the patients
and the most frequent reason for seeking a con-
sultation. In a study conducted on 1,171 healthy
premenopausal US women, 11 per cent presented
moderate to severe breast pain that interfered with
regular sexual activity, everyday physical activities,
social and school activities [27, 28]. In this study
53.6% of patients presented moderate pain and
13.7% severe pain at the start of the treatment.
Pain was reduced in the three therapies applied.
Pain reduction in the group treated with deep os-
cillations was statistically significant when compa-
red to the groups treated with ibuprofen and me-
droxi-progesterone. Studies conducted on the use
of deep oscillation therapy in conservative breast
carcinoma surgery, from the immediate postope-
rative period onwards, preventive treatment and
complementary lymphedema therapy, showed en-
couraging results [29-30].
The DEEP OSCILLATION® device uses the forces
of friction and pulsed electrostatic attraction to cau-
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
This article is available at: www.intarchmed.com and www.medbrary.com8
se oscillations that act on the epidermis, dermis and
subcutaneous layers of tissue.
At the start of this research we checked the mag-
nitude of resonant vibration of the connective tissue
from the surface to the deep layers. This was done
by applying diagnostic ultrasound at the same time
as the treatment on patients, making it possible to
view the effect of the deep oscillations. This me-
chanical effect on a localised level activates mode-
rate vasoconstriction and reabsorption of localised
oedemas. Furthermore, the uninterrupted vibrating
effect leads to a relaxation in the connective tissue,
inhibiting localised fibrosis. For the first time, this
study permitted viewing in situ the vibrating effect
of the deep oscillation therapy.
A sign test was conducted with the purpose of
checking for any significant differences in the scores
before and after the treatment. This test allows us
to compare the hypothesis that the responses to
two or more treatments belong to identical popula-
tions. For the use of this test the only thing required
is for the underlying populations to be continuous
and that the responses of each associated pair be
measured on at least an ordinal scale. The results of
this study allow us to state that there are differences
between the results of the reported score for the
pain scale before and after treatment, for p≤0.05
(Z=-1.136; p=0.256) when comparing the group
treated with deep oscillations with the groups that
received pharmacological treatment.
In the analysis of the sonogram findings at the
start of this study, the most frequent alteration
found was the presence of fibrosis, something that
corresponds with what is described in the literature
where, while it is reported as one of the principal
clinical characteristics of breast dysplasia, which is
present in approximately 44% to 55.5% of women,
particularly between 25 and 40 years of age [8],
other authors consider that in fibrocystic breast di-
sease there is inflammation as a characteristic of
the advanced phase, a consequence of cyst ruptu-
re, which liberates the contents to the underlying
stroma, leading to chronic inflammation and fibrosis
scar tissue, which are responsible for the palpable
breast hardness. No studies were found that asses-
sed the ultrasound scan as a parameter of fibro-
cystic disease evolution after treatment with deep
oscillation therapy.
Through the resonant vibration produced on tis-
sue, deep oscillation therapy facilitates moderate
vasoconstriction, reduces edema and thus favours
blood flow and the right amount of oxygen supply
to tissues propitiates a positive therapeutic effect in
fibrocystic breast disease, which is attributable to
three fundamental reasons: relaxing effect on tis-
sues, moderate vasoconstriction effect and increa-
sed interstitial drainage, which favours reabsorption
of localised oedema and reduces localised fibrosis.
Several studies document the anti-inflammatory,
analgesic, muscle-relaxant and tissue-regenerating
effect of deep oscillation therapy.
Incorrect bra use is a factor that may have a bea-
ring on breast pain. In the study of 401 women
who attended the clinical evaluation consultation to
participate in the research, they were asked which
bra size they were currently wearing and then we
analysed whether the bra size was correct. 398 wo-
men were wearing the wrong bra size. The multiple
regression analysis to evaluate the correlation of the
various factors, such as wrong bra size, showed a
strong link (Pearson’s correlation = 0.53, p 0.001)
between incorrect band measurement and excess
weight of the women wearing the wrong bra size.
In 254 women the band measurement was inco-
rrect; in 100 the cup size was wrong and 44 of
them had the wrong band size-cup size correlation.
During the interview we investigated the aspects
they took into account in order of priority when
selecting a bra. 86% alleged that priority was given
to the model, followed by colour. We can state that
the majority of the women studied were using a
bra incorrectly, propitiating the persistence of pain.
International Archives of Medicine
Section: Physical Medicine  Rehabilitation
ISSN: 1755-7682
2018
Vol. 11 No. 14
doi: 10.3823/2555
© Creative Commons Attribution 4.0 International (CC BY 4.0) License 9
Conclusions
Pain was reduced in the three therapies applied.
In the study group this reduction was statistically
significant.
It is possible to check the magnitude of the reso-
nant vibration in the connective tissue, from the sur-
face layers to the deep layers, by viewing the effect
of deep oscillations through the use of a diagnostic
ultrasound scan.
The most frequent sonogram finding was fibrosis.
Deep oscillation therapy produces a tissue-relaxing
and moderate vasoconstriction effect, favours reab-
sorption of localised oedema and reduces fibrosis.
A factor that may have a bearing on breast pain
is the incorrect use of the bra. Most of the women
studied were using the bra incorrectly.
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Research and Development 2015 2(1), 286-289.
	
International Archives of Medicine is an open access journal
publishing articles encompassing all aspects of medical scien-
ce and clinical practice. IAM is considered a megajournal with
independent sections on all areas of medicine. IAM is a really
international journal with authors and board members from all
around the world. The journal is widely indexed and classified
Q2 in category Medicine.
Publish in International Archives of Medicine

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The Effect of Deep Oscillation in Fibrocystic Breast Disease. A Randomized Controlled Clinical Trial

  • 1. International Archives of Medicine Section: Physical Medicine & Rehabilitation ISSN: 1755-7682 International Medical Society http://imedicalsociety.org 1 2018 Vol. 11 No. 14 doi: 10.3823/2555 © Creative Commons Attribution 4.0 International (CC BY 4.0) License This article is available at: www.intarchmed.com and www.medbrary.com Abstract Introduction: Fibrocystic breast disease is the most widespread di- sorder in women during their phase of sexual maturity. Deep oscilla- tion (DO) therapy has been used on patients who have undergone an operation for breast cancer as a special form of manual lymphatic drainage. Method: Experimental, prospective case-control studies were con- ducted in 401 women diagnosed with fibrocystic breast disease. The sample was selected at random and was divided into three groups, a study group and two control groups. Results: Pain was reduced in the three therapies applied. This was statistically significant in the study group. The sonography study pre- sented a predominance of its fibrous form. Upon completion of the treatment a resolution of the fibrosis was observed in the study group. The women were using their bra in an incorrect manner. Conclusions: Pain was reduced in the three therapies applied. In the study group this reduction was statistically significant. It is possible to verify the magnitude of the resonant vibration in the connective tissue from surface to deep layers by viewing the effect of the deep osci- llations through the use of diagnostic ultrasound. The most frequent sonographic finding was fibrosis. Deep oscillation therapy produces a tissue-relaxing, moderate vasoconstriction effect, favours local oe- dema reabsorption and fibrosis reduction. A factor that may affect breast pain is incorrect bra use. The majority of women studied were using their bra incorrectly. The Effect of Deep Oscillation Therapy in Fibrocystic Breast Disease. A Randomized Controlled Clinical Trial ORIGINAL Solangel Hernández Tápanes1, Marilyn de Jesús Socas Fernández1, Yinet Iturralde2, Addiel Suáres Fernández3 1  Specialist in Physical Medicine Rehabilitation. University Clinic Luis de la Puente Uceda. Havana Cuba. 2  Specialist in Gynecology and Obstetrics. University Clinic. Luis de la Puente Uceda. Havana Cuba. 3  Physical Therapist University Clinic Luis de la Puente Uceda. Havana Cuba. Contact information: Solangel Hernandez. Address: Specialist in Physical Medicine Rehabilitation. University Clinic Luis de la Puente Uceda. Havana Cuba. solangel@portalamlar.org Keywords Deep Oscillations; Fibrocystic Breast Disease; Benign Breast Disease; Mammary Dysplasia.
  • 2. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 This article is available at: www.intarchmed.com and www.medbrary.com2 Introduction Fibrocystic breast disease (CIE 10 N 64.0) is the most widespread disorder in women during their phase of sexual maturity, with or without clinical manifestations. The breast is one of the target or- gans of ovarian hormones; disruptions in the ova- rian cycle lead to fibrocystic disease, which cau- ses considerable discomfort in a high number of women between the ages of 35 and 50 [1]. Its clinical-histopathological alterations are produced by a possible oestrogen-progesterone hormonal imbalance, which induces persistent changes in the ductal-lobular unit, both in the epithelial and in the conjunctival component. It is characterised by inflammatory events and proliferative histological changes that may be cysts, apocrine metaplasia, conjunctival hyperplasia, ductal ectasia, epithelial hyperplasia [2-4]. Generally a painful breast complaint indicates a functional disorder or a benign illness; however, breast cancer can present itself with pain, and so in the presence of any kind of breast pain it is re- commended to pay special attention [5-7]. Fibrocystic breast disease accounts for 54% of breast diseases and 70% of benign lesions; it affects one of every two women of childbearing age although it may appear in any stage of life. In Cuba it represents 49.8% of all breast disea- se and thus constitutes an important problem in women’s health. Many do not consider it a disease but rather an unpleasant condition for women, one with which they have to learn to live, given that it is a process that occurs clinically and histo- logically in between 50% and 90% of women [8]. The term benign breast condition includes: - Fibrocystic disease (also called mammary dys- plasia, fibrocystic condition, fibrocystic chan- ges, among others). - Benign tumours. - Inflammations. Fibrocystic changes can be grouped into 3 histo- pathological forms: - Fibrous hyperplasia, with a predominance of conjunctival tissue. - Cystic hyperplasia, with a predominance of variable-size cysts. - Sclerosing adenosis, when the following asso- ciate: increase of small lobes, intracanalicular lo- bular fibrosis and variable degrees of epithelial hyperplasia [9]. In fibrocystic disease micro-cysts predominate. They are more frequent in the 40 to 50 age range (42%). Pain and nodules are almost constant symp- toms; nipple discharge is infrequent. Pain drives the woman to consult a doctor, although in some cases it is nodularity that does this, which can be unilateral or bilateral; its intensity increases as the menstrual cycle progresses and is relieved or disap- pears with the onset of menstruation. A differen- tial diagnosis should be made with other types of breast pain in order to rule out selective dyspla- sias or cancer. It becomes important to make the differential diagnosis with malignant neoplasms that may be overestimated in the premenstrual phase and lead to errors in interpretation; someti- mes they are identical to carcinoma. Between 5% and 10% of cases are due to extramammary cau- ses: ribcage osteochondritis, intercostal neuralgia, stress-related muscle pain (pectoralis major mus- cle, latissimus dorsi), mammary pain due to spinal root syndrome, cervical radiculopathy, intramam- mary adenitis and premenstrual syndrome, among others. In all cases it is important to physically examine the breasts and the underarm region, complemen- ted with sonography, mammogram and pap smear [10-12]. A sonogram is the most useful study, as it defines whether the lesions are cystic or solid; it is also required as a complement to a mammogram in lesions of an undefined nature. A biopsy or fine-needle aspirate cytology is an innocuous method and in doubtful cases provides a cytological diagnosis, particularly in complex no- dules or masses that are non-painful or discretely
  • 3. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 © Creative Commons Attribution 4.0 International (CC BY 4.0) License 3 painful as well as in lesions that undergo little or no modification in the fluctuations of the menstrual cycle. It also permits the evacuation of septated cysts, which are frequent in the involutive phase of the process. Pharmacological treatment for fibrocystic breast disease is heterogeneous. It includes therapies with: danazol, tamoxifen, ormeloxifene, oral analgesic and anti-inflammatory treatments, local nonste- roidal anti-inflammatory treatment, progesterone, ginseng, linseed, phytoestrogens (isoflavones), eve- ning primrose oil, vitamin B6, vitamin E [13-17]. Anti-inflammatory treatment relieve pain and swelling in general without modifying the course of the illness. Their effect depends on the inhibition intensity of prostaglandin synthesis. The majority of adverse effects also depend on this action. Treatment should be aimed at combating the cau- ses that give rise to it, with three basic objectives: - Dietary and hygienic measures, - Invasive treatment (puncturing cysts, surgical excision of nodes, complex cystic lesions or their residual capsule, etc.) - Provide all possible information, modify lifes- tyles and promote the systematic practice of breast self-examination. Stress is a contributing or resulting factor in pain and controlling it is an integral part of treatment through evaluation and the use of psychological support techniques, complemented with educating the patient and providing her with information. Another critical factor to take into account is the right postural treatment of the cervico-dorsal spinal column and the correct use of the bra. The use of a well-fitting breast brace that provides full support should be considered in achieving a reduction of cyclical and non-cyclical breast pain. Vitamins E and B6 are often prescribed in patients with fibrocystic breast disease. Revised studies conclude that the consumption of vitamin E has not demonstrated any evidence for consideration in the treatment of breast pain, and for the consumption of vitamin B6 there is insufficient evidence to demonstrate its effectiveness. There is little research into breast pain in regard to the administration of pain relief such as acetamino- phen or nonsteroidal anti-inflammatory treatments. In contrast to the above-mentioned conventional therapies, which act on the neuromuscular system, treatment with electrotherapy in deep oscillation therapy acts on the conjunctival tissue through weak electrostatic charges [18-19]. This therapy has been used in the treatment of patients who have undergone an operation for breast cancer, as a special form of manual lympha- tic drainage that has made it possible to start using a prophylactic procedure right from the first day of the postoperative period thanks to the early rechan- neling of the lymphatic drainage tracts in order to prevent both the formation of lymphedemas and painful shoulder syndrome. This therapy has been shown to be efficacious in diminishing the secon- dary effects of radiotherapy [20, 21]. For these reasons it was decided to conduct a study of patients diagnosed with fibrocystic breast disease treated with deep oscillation therapy, com- paring their evolution with those treated in a con- ventional manner. Method Experimental, prospective case-control research was conducted in 401 women diagnosed with fibro- cystic breast disease in the period from December 2009 to December 2014. The universe comprised female patients between 20 and 50 years of age who attended the specialised breast disease clinic. The sample was selected randomly and was divided into three groups. Approved by the Ethics Com- mittee of the University Polyclinic Luis de la Puente Uceda. Register number 01245 - Group I or study group: 106 patients who were given deep oscillation therapy (with a Hivamat 200® device by PHYSIOMED®) based on the
  • 4. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 This article is available at: www.intarchmed.com and www.medbrary.com4 following parameters: frequency, intensity, vi- bration and mode. The treatment plan cove- red 3 weeks (15 sessions), a daily session from monday to friday. - Group II: 146 patients who were treated with ibuprofen (nonsteroidal anti-inflammatory treatment), 1 400-mg tablet every 12 hours for three weeks. - Group III: 149 patients who were treated with medroxi-progesterone, 1 25-mg ampoule ad- ministered intramuscularly from the second half of the menstrual cycle onwards and on alterna- te days, for a total dosage of 150 mg. Objective General To evaluate the efficacy of deep oscillation therapy in fibrocystic breast disease. Specific - To assess the effect of the treatment on the evolution of pain. - To describe the effect of the treatment accor- ding to sonogram evolution. - To determine incorrect bra use. Criteria for the selection of the sample For inclusion - Patients with fibrocystic breast disease aged between 20 and 50 years. - Patients who were given prior information on the characteristics of the study and accepted the conditions. For exclusion - Patients with decompensated cardiovascular conditions, pacemakers in the treatment area. - Patients with infectious skin conditions in the region being treated. - Patients with nipple discharge. - Malignant diseases. - Pregnancy. - Sensitivity to electric fields. Exit criteria - Patients who stopped treatment after they were included in the study. Study phases - Diagnostic phase - Treatment phase - Evaluation phase Diagnostic phase After the sample had been selected and formed after having confirmed the diagnosis of fibrocystic breast disease, the clinical history was drawn up, which included initial assessment, questioning, phy- sical examination and diagnosis as well as a sono- gram study and BAFF puncture where appropriate. Treatment phase The patients from the study group were given deep oscillation therapy (Hivamat 200® device) under the following parameters: frequency, intensity, vibration (mode), time and sessions. - First time: 5 min, frequency of 160 Hz, 50% intensity, vibration (mode) 2. This plan succee- ded in dissolving the fibrosis and relieved pain. - Second time: 3 min, frequency of 60 Hz, 50% intensity, vibration (mode) 2. This plan succee- ded in stimulating lymphatic drainage and re- ducing breast congestion. - Third time: 4 min, frequency of 15 Hz, 50% intensity, vibration (mode) 2. This plan succee- ded in increasing interstitial liquid flow and im- proving the release of adjacent muscular fascia. Total programme time: 12 minutes (for each breast). Procedure Patient in a supine position with the hand corres- ponding to the treated breast placed underneath the nape, devoid of clothing; with the use of the 5-centimetre manual applicator, at the level of the affected breast (s), in a clockwise direction, during 12 min. (Figure 1)
  • 5. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 © Creative Commons Attribution 4.0 International (CC BY 4.0) License 5 Evaluation phase When the rehabilitation treatment sessions were completed, and by means of questioning, physical examination and evolutionary sonogram study, we checked for persistence of symptoms and sonogram patterns. We proceeded likewise with those who received conventional treatment. Visual analogue scale (VAS) for pain severity: On the continuous line, the patient marks the de- gree of painful sensation between both ends, with the rating from 0 to 10 indicated on the back. The scale was subdivided to group it into: - 0 No pain - 1-3 slight pain - 4-7 moderate pain - 8-10 severe pain The principal advantage is that it does not require verbal or reading abilities and is sufficiently versa- tile for using it in different situations. Thanks to its validity, reliability and capacity to reflect changes in pain intensity, it is one of the most widely used scales. A database and clinical histories were created with the initial assessment, questioning, physical examination, diagnosis, BAFF puncture and sono- gram study. Experimental procedure Conditions of the device German-made HIVAMAT 200® devices by PHYSIO- MED® were utilised, with the use of the 5-centime- tre manual applicator and suitable contact between patient and manual applicator. Talcum powder was used as a vehicle between the membrane of the manual applicator and the patient’s skin. Search for information The search strategy for conducting the research was developed over the period between Decem- ber 2009 and January 2013. Searches were made in online databases: EBSCO, LILACS, Medline and Cochrane Library, supported by the EndNote 7 per- sonal database manager. The MeSH (Medical Subject Headings) terms: mammary dysplasia, fibrocystic breast disease. We reviewed reference books by relevant authors on oncology, surgery and gynaeco- logy and obstetrics, pharmacology, physical thera- peutic agents and specialised magazines. The levels of evidence and degrees of recommendation were hierarchically based on the classification system of the Agency for Healthcare Research and Quality. Statistical analysis We used descriptive statistics of the data with sum- mary indicators of absolute frequency (No) and rela- tive frequency (%) in individuals, depending on the category described. As a statistical test, to conduct corroborating treatment evolution according to the above-men- tioned pain scales and sonogram results, we used the sign test. For hypothesis corroboration we set p0,05. The statistical packages used for analysis were Stagraphic plus and NCSS-PASS-GESS for Windows. The results were recorded on tables. All ethical aspects of biomedical research were met and guarantees were provided that there would be no conflict of interest with PHYSIOMED®, the company that produces the deep oscillation devices. Figure 1: Treatment method whith deep oscillation therapy in fibrocystic breast disease. © Hernandez Tápanes Solangel. MD.
  • 6. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 This article is available at: www.intarchmed.com and www.medbrary.com6 Results Table 1 shows a predominance of ages between 31 and 40 years in the distribution by age: in Group I with 64 patients for 60.4%, Group II with 86 pa- tients for 58.9% and Group III with 95 patients for 63.8% of the members of these groups. In re- gard to the presence of toxic habits in the patients studied, the most frequent one to be evinced was coffee ingestion in 30.2% of patients and 23.7% with a smoking habit, which was significant in both identified factors. There were no statistically signifi- cant differences between the groups. Table 2 shows the use of contraceptives in the studied groups, where 34.7% of patients used oral contraceptives and 11.5% injectable contraceptives, while 53.9% used no contraceptive hormones at all. There were no significant differences between the groups (p=0.67). Pain assessment is presented in Table 3, where the data gathered at the end of the treatment show that 63.2% of patients in Group I had no pain, nor did 24.6% of patients in Group II nor 21.5% of patients in Group III, with significant statistical differences in pain relief between the 3 therapies (p=0.01). In the study group, at the end of the treatment no patient had any pain of moderate or severe intensity. A sign test was conducted to check the differen- ces in scores before and after treatment. The study group revealed significant differences between sco- res for pain before and after treatment for p≤0.04 (Z=-6.161; p=0.00). When comparing the group treated with deep oscillations with the control groups with pharmaco- logical treatment, statistically significant differences were found between the results of the scores repor- ted for the pain scale before and after treatment, for p≤0.05 (Z=-1.136; p=0.01). Based on these data, it is possible to state that there are statistically signi- ficant differences in the evolution of pain in patients treated with deep oscillations when compared to those who received pharmacological treatment. Table 1. Distribution by age and toxic habits. Groups Total Ages Coffee Tobacco 20-30 31-40 41-50 Total % Total % Total % Total % Total % I 106 25 23.6 64 60.4 17 16.0 32 30.2 22 20.8 II 146 33 22.6 86 58.9 27 18.5 46 31.5 29 19.9 III 149 30 20.1 95 63.8 24 16.1 43 28.8 44 29.5 Total 401 88 22.0 245 61.0 68 17.0 121 30.2 95 23.7 Source: Survey x2=0.98 p=0.81 x2=1.72 p=0.97. Table 2. Use of contraceptives. Groups Total Oral contraceptives Injectable contraceptives No contraceptives No % No % No % I 106 36 34.0 12 11.3 58 54.7 II 146 47 32.2 17 11.6 82 56.2 III 149 56 37.6 17 11.4 76 51.0 Total 401 139 34.7 46 11.5 216 53.9 Source: Survey x2=2.86 p=0.67. Table 3. Presence of pain according to verbal nume- rical scale, by therapeutic plan at the start and end of the treatment. Groups Start End No Pain Slight Moderate Severe No Pain Light Moderate Severe I 0 30.2 56.7 14.2 63.2 36.8 0 0 II 0 34.2 53.4 12.3 24.6 46.6 26.0 2.7 III 0 32.9 52.3 14.8 21.5 43.0 25.5 10.1 Total 0 32.7 53.6 13.7 33.7 42.6 18.9 4.7 Source: Survey x2=0.98 p=0.80 x2=1.72 p=0.01. Table 4. Sonogram findings by therapeutic plan at the start and end of the treatment. Sonogram findings Before After GI GII GIII GI GII GIII Fibrosis 75.5 72.0 73.8 17.5 67.1 67.1 Adenosis 15.1 21.2 13.0 11.3 17.8 10.7 Cyst 9.4 6.8 13.4 5.7 10.3 12.7 Total 0 32.7 53.6 13.7 33.7 42.6 Source: Survey x2==1.52 p=0.05.
  • 7. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 © Creative Commons Attribution 4.0 International (CC BY 4.0) License 7 Table 4 shows the results of the sonogram study conducted with patients before and after treatment. The initial assessment showed a predominance of its fibrous form (78.5%), followed by adenosis (16.4%) and cystic form (10.0%). The fibrosis represented 75.5% in group I, 72.0% in group II and 73.8% in group III, similar figures to a study conducted on 1,551 patients in which fibrocystic disease in its fibrous form prevailed. Upon completion of the treatment, statistically significant changes were ob- served in the resolution of the fibrosis in group I. In groups II and III, while the number of patients with fibrosis diminished, this reduction was not statisti- cally significant. During the physical examination appropriate bra use was explored in regard to breast size in the 401 patients studied. Of these, 320 women, 70.1%, were using the bra incorrectly, and of these 52.4% the cup size was smaller than the breast size. Discussion Behaviour relating to age, toxic habits and use of contraceptives in this study allows us to determine the resemblance of the groups and the diminution in bias in their comparison. These variables are pre- sented separately, but we can announce that there are no statistically significant differences in these variables in the different groups, which speaks in favour of comparing them. In regard to age, we observed that fibrocystic disease is more frequent after the age of 30. Some papers record that it is more frequent between the ages of 25 and 40 and others between 40 and 50, a phase which coincides with sexual maturity and consequently frequent hormonal disorders [1, 8, 22]. Table 1 shows that of a total of 401 patients, 61.0% were aged between 31 and 40 years and only 17.0% between 41 and 50. In regard to the presence of toxic habits in the patients studied, there were no statistically signifi- cant differences between the groups. Coffee drin- king was a habit among 30.2% of patients and smoking among 23.7%. Data similar to those found in the literature we consulted, based on non-en- docrine theories, are supported by a biochemical basis from observing excessive quantities of AMPc in breast tissue owing to excessive consumption of methylxanthines, which are abundant in drinks such as tea, coffee, chocolate, colas, alcoholic bevera- ges, as well as the harmful effect of nicotine, which would be the most likely direct cause [23, 24]. The consumption of tea, chocolate, cola or alcoholic be- verages was not significant. In relation to the use of contraceptives, no sta- tistically significant differences were found between the groups. 34.7% used oral and 11.5% injectable contraceptives. Revised studies consider that the use of contraceptives can trigger crises, while others hold that it bears no relation at all. In this study, in a total of 34.7% of women the disease was asso- ciated with the use of oral contraceptives [25, 26]. The presence of breast pain or mastodynia is the most persistent syndrome cited by the patients and the most frequent reason for seeking a con- sultation. In a study conducted on 1,171 healthy premenopausal US women, 11 per cent presented moderate to severe breast pain that interfered with regular sexual activity, everyday physical activities, social and school activities [27, 28]. In this study 53.6% of patients presented moderate pain and 13.7% severe pain at the start of the treatment. Pain was reduced in the three therapies applied. Pain reduction in the group treated with deep os- cillations was statistically significant when compa- red to the groups treated with ibuprofen and me- droxi-progesterone. Studies conducted on the use of deep oscillation therapy in conservative breast carcinoma surgery, from the immediate postope- rative period onwards, preventive treatment and complementary lymphedema therapy, showed en- couraging results [29-30]. The DEEP OSCILLATION® device uses the forces of friction and pulsed electrostatic attraction to cau-
  • 8. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 This article is available at: www.intarchmed.com and www.medbrary.com8 se oscillations that act on the epidermis, dermis and subcutaneous layers of tissue. At the start of this research we checked the mag- nitude of resonant vibration of the connective tissue from the surface to the deep layers. This was done by applying diagnostic ultrasound at the same time as the treatment on patients, making it possible to view the effect of the deep oscillations. This me- chanical effect on a localised level activates mode- rate vasoconstriction and reabsorption of localised oedemas. Furthermore, the uninterrupted vibrating effect leads to a relaxation in the connective tissue, inhibiting localised fibrosis. For the first time, this study permitted viewing in situ the vibrating effect of the deep oscillation therapy. A sign test was conducted with the purpose of checking for any significant differences in the scores before and after the treatment. This test allows us to compare the hypothesis that the responses to two or more treatments belong to identical popula- tions. For the use of this test the only thing required is for the underlying populations to be continuous and that the responses of each associated pair be measured on at least an ordinal scale. The results of this study allow us to state that there are differences between the results of the reported score for the pain scale before and after treatment, for p≤0.05 (Z=-1.136; p=0.256) when comparing the group treated with deep oscillations with the groups that received pharmacological treatment. In the analysis of the sonogram findings at the start of this study, the most frequent alteration found was the presence of fibrosis, something that corresponds with what is described in the literature where, while it is reported as one of the principal clinical characteristics of breast dysplasia, which is present in approximately 44% to 55.5% of women, particularly between 25 and 40 years of age [8], other authors consider that in fibrocystic breast di- sease there is inflammation as a characteristic of the advanced phase, a consequence of cyst ruptu- re, which liberates the contents to the underlying stroma, leading to chronic inflammation and fibrosis scar tissue, which are responsible for the palpable breast hardness. No studies were found that asses- sed the ultrasound scan as a parameter of fibro- cystic disease evolution after treatment with deep oscillation therapy. Through the resonant vibration produced on tis- sue, deep oscillation therapy facilitates moderate vasoconstriction, reduces edema and thus favours blood flow and the right amount of oxygen supply to tissues propitiates a positive therapeutic effect in fibrocystic breast disease, which is attributable to three fundamental reasons: relaxing effect on tis- sues, moderate vasoconstriction effect and increa- sed interstitial drainage, which favours reabsorption of localised oedema and reduces localised fibrosis. Several studies document the anti-inflammatory, analgesic, muscle-relaxant and tissue-regenerating effect of deep oscillation therapy. Incorrect bra use is a factor that may have a bea- ring on breast pain. In the study of 401 women who attended the clinical evaluation consultation to participate in the research, they were asked which bra size they were currently wearing and then we analysed whether the bra size was correct. 398 wo- men were wearing the wrong bra size. The multiple regression analysis to evaluate the correlation of the various factors, such as wrong bra size, showed a strong link (Pearson’s correlation = 0.53, p 0.001) between incorrect band measurement and excess weight of the women wearing the wrong bra size. In 254 women the band measurement was inco- rrect; in 100 the cup size was wrong and 44 of them had the wrong band size-cup size correlation. During the interview we investigated the aspects they took into account in order of priority when selecting a bra. 86% alleged that priority was given to the model, followed by colour. We can state that the majority of the women studied were using a bra incorrectly, propitiating the persistence of pain.
  • 9. International Archives of Medicine Section: Physical Medicine Rehabilitation ISSN: 1755-7682 2018 Vol. 11 No. 14 doi: 10.3823/2555 © Creative Commons Attribution 4.0 International (CC BY 4.0) License 9 Conclusions Pain was reduced in the three therapies applied. In the study group this reduction was statistically significant. It is possible to check the magnitude of the reso- nant vibration in the connective tissue, from the sur- face layers to the deep layers, by viewing the effect of deep oscillations through the use of a diagnostic ultrasound scan. The most frequent sonogram finding was fibrosis. Deep oscillation therapy produces a tissue-relaxing and moderate vasoconstriction effect, favours reab- sorption of localised oedema and reduces fibrosis. A factor that may have a bearing on breast pain is the incorrect use of the bra. Most of the women studied were using the bra incorrectly. References 1. Nápoles Méndez D. Atención a pacientes con afecciones benignas de la mama durante 11 años (Care of patients with benign breast conditions over 11 years). MEDISAN [Internet magazine]. 2013 Dec. [quoted 2015 Jan. 07]; 17(12): 9144- 9152. Available on: http://scielo.sld.cu/scielo.php?script=sci_ arttextpid=S1029-30192013001200015lng=es 2. Okolowsky N, Furth PA, Hamel PA. Oestrogen receptor-alpha regulates non-canonical Hedgehog-signalling in the mammary gland. Dev Biol. 2014 Jul. 15; 391(2):219-29. doi: 10.1016/j. ydbio.2014.04.007. Epub 2014 Apr 21. 3. Zendehdel M, Niakan B, Keshtkar A, Rafiei E, Salamat F. Subtypes of Benign Breast Disease as a Risk Factor for Breast Cancer: A Systematic Review and Meta-Analysis Protocol. Iran J Med Sci. 2018 Jan; 43(1):1-8. Available in: https://www.ncbi.nlm.nih.gov/ pubmed/29398746) 4. Pereira MA, Segura ME, Santos AM, Casulari LA. Regression of the fibrous disease of the breast in a non-diabetic woman after pregnancy and breastfeeding. Arq Bras Endocrinol Metabol. Dec; 2007, 51(9):1539-43. 5. Park JH, Chun M, Jung YS, Bae SH. Predictors of Psychological Distress Trajectories in the First Year After a Breast Cancer Diagnosis. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec; 11(4):268-275 Available in: https://www.ncbi.nlm.nih.gov/ pubmed/29290274 6. JohannsenM,FrederiksenY,JensenAB,ZachariaeR.Psychosocial predictors of posttreatment pain after nonmetastatic breast cancer treatment: a systematic review and meta-analysis of prospective studies. J Pain Res. 2017 Dec 21; 11:23-36. Available in: https://www.ncbi.nlm.nih.gov/pubmed/29317846 7. Langford DJ, Schmidt B, Levine JD, Abrams G, Elboim C, Esserman L, et al. J Pain Symptom Manage. 2014 Dec 16. pii: S0885- 3924(14)00915-4. doi: 10.1016/j.jpainsymman.2014.11.292. 8. Rodríguez Pérez A., Castell Moreno J. Afecciones mamarias (Breast Conditions). Havana: Editorial Ecimed; 2010. Chap. 3. p. 48-99. 9. Kabat GC, Jones JG, Olson N, Negassa A, Duggan C, Ginsberg M, et al. A multi-center prospective cohort study of benign breast disease and risk of subsequent breast cancer. Cancer Causes Control. 2010; 21:821-8. 10. Pailoor K, Fernandes H, Cs J, Marla NJ, Keshava S M. Fine needle aspiration cytology of male breast lesions - a retrospective study over a six year period. J Clin Diagn Res. 2014 Oct; 8(10):FC13-5. doi: 10.7860/JCDR/2014/10708.4922. Epub 2014 Oct 20. 11. Rinaldi P, Lerardi C, Costantini M, Magno S, Giulani M,Belli P, et al. Cystic breast lesions: sonographic findings and clinical management. J Ultrasound Med. 2010; 29:1617- 26 12. Destounis S, Arieno A, Morgan R. New York State Breast Density Mandate: Follow-up Data With Screening Sonography. J Ultrasound Med. 2017 Dec; 36(12):2511-2517. doi: 10.1002/ jum.14294. Epub 2017 Jun 28. Available in: https://www.ncbi. nlm.nih.gov/pubmed/28656638 13. Kumar S, Rai R, Agarwal GG, Dwivedi V, Kumar S, DAS V. A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. Natl Med J India. 2013 Mar-Apr; 26(2):69-74. 14. Carauleanu A, Socolov R, Rugina V, Gabia O, Carauleanu DM, Lupascu IA, Socolov D. Comparisons between the non- proliferative and proliferative therapy in fibrocystic mastosis. Rev Med Chir Soc Med Nat Iasi. 2016 Apr-Jun; 120(2):321-7. Available in: https://www.ncbi.nlm.nih.gov/pubmed/27483712 15. Mainero Ratchelous E, Aguilar Gallegos I, Pedraza Barajas S, Vargas Hernández VM. Guias de prácticas clínicas. Tratamiento de la mastalgia (Guide to Clinical Practices. Treatment of Mastalgia). Ginecol Obstet Mex; 2009, 77(12):S371-S390 16. Deschamps M1, Band PR, Coldman AJ, Hislop TG, Longley DJ. Clinical determinants of mammographic dysplasia patterns. Cancer Detect Prev. 1996; 20(6):610-9. 17. Gallo Vallejo JL, Mas Masats MP, Vico Zúniga I, Aibar Villánd L. Mastopatía fibroquística. Aspectos controvertidos (Fibrocystic Mastopathy. Controversial Aspects). Clin Invest Gin Obst.2013. Available in: http://dx.doi.org/10.1016/j.gine.2013.02.006
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