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Ozone Therapy 2016; volume 1:5842
[Ozone Therapy 2016; 1:5842] [page 17]
Abstract
Idiopathic low back pain can be considered as a chronic condition,
characterized by recurrent episodes of pain and functional limitation.
The aim of this study is to compare two therapeutic methods to treat
this chronic disease: the oxygen-ozone therapy and the diathermy
through Tecar®therapy. Two groups of 10 patients each who suffered
from postural idiopathic low back pain due to different pathologies
have been recruited. All selected patients have been evaluated
through spinometry and have been given the Oswestry low back pain
disability questionnaire to fill in at the beginning of the treatments
and at the end of them with a three-month follow-up. The first group
underwent a diathermy treatment through Tecar®therapy, whilst the
second group received an oxygen-ozone therapy treatment through a
paravertebral lumbar infiltration; both treatments have been associat-
ed with a standard physiokinesitherapy treatment. Data collected
through Formetric spinometry show an improvement in both groups,
but in the second group (treated with oxygen-ozone therapy+phys-
iokinesitherapy), the improvement is greater (from 6% to 57%)
against the first group (from 20% to 38%). In conclusion, the study
has cor roborated the validity of both treatments leading to improve-
ment of symptomatology, but while one treatment leads to some
relapses after a few months, the second one has a greater healing
effect, which preserves over time.
Introduction
Definition
Idiopathic low back pain can be considered to all intents and purposes,
as a chronic condition, characterized by recurrent episodes of pain and
functional limitation. Low back pain may have different origins, since any
pathology of the lumbar spine can cause pain in this region. However, the
most common causes are the degenerative ones that is to say due to the
wear and tear of disc and articular structures. Degenerative forms shall
be differentiated from those due to other causes.
Low back pain classification
Discogenic
Its occurrence is observed mainly in the age group 30 to 50. It is
caused by the degenerative discopathy of one or more intravertebral
discs. The most affected discs are L4-L5 and L5-S1. The low back pain
can be acute, chronic or recurrent.
Arthrogenic
Its occurrence is observed in patients over 50. Usually the low back
pain is chronic, however in most cases it is less intense than the disco-
genic one. The instrumental examinations [X-rays (XR), computed
tomography (CT), nuclear magnetic resonance (NMR)] show
arthrosic alterations of back articulations at low lumbar spine level or
in the spine in general and often also the narrowness of one or more
discs due to degenerative alterations.
Due to vertebral instability
The pain is only present during the prolonged upright standing,
the protracted walking, or during physical efforts. In these cases it is
usually a degenerative spondylolisthesis, noticeable through the lat-
eral XR, with hypermobility of the concerned vertebra in flexion-
extension XR.
Due to other causes
The pain in the lumbar region, which is usually chronic, can be
caused by several other vertebral pathologies, such as: tumors, infec-
tions o rheumatic diseases, extra-vertebral pathologies (retroperi-
toneal tumors, abdominal aortic aneurysm).
In the majority of cases in which no pathological alterations to
lumbar spine are found (through the standard XR, NMR methods),
the low back pain is idiopathic, that is to say, without any known
cause.
It usually concerns young or middle-aged people, whose pain can be
caused by postural defects during their working activity, by an inade-
Correspondence: Luca Morelli, San Fedele Physiotherapy Clinic, via Risorgi-
mento 1, 22030 Longone al Segrino (CO), Italy.
Tel.: +39.031.3333585.
E-mail: info@centrosanfedele.it
Key words: Idiopathic low back pain; oxygen-ozone therapy; diathermy;
Tecar®therapy; physiokinesitherapy.
Received for publication: 12 January 2016.
Accepted for publication: 24 February 2016.
©Copyright L. Morelli et al., 2016
Licensee PAGEPress, Italy
Ozone Therapy 2016; 1:5842
doi:10.4081/ozone.2016.5842
This article is distributed under the terms of the Creative Commons
Attribution Noncommercial License (by-nc 4.0) which permits any noncom-
mercial use, distribution, and reproduction in any medium, provided the orig-
inal author(s) and source are credited.
Comparison among different therapeutic techniques to treat low back pain:
a monitored randomized study
Luca Morelli,1,2 Simona Carla Bramani,1Marco Cantaluppi,2Mara Pauletto,2 Alessandro Scuotto2
1San Fedele Physiotherapy Clinic, Longone al Segrino (CO), Italy; 2LUdeS Foundation Higher
Education Institution, Lugano, Switzerland
Non-commercial use only
quate mobilization of the spine or by the manual handling of loads,
which is performed incorrectly.
In many cases in idiopathic low back pain there is a pain psy-
chogenic component, above all in hypochondriac or depressed subjects.
Materials and Methods
The study
We have planned this study to compare two therapeutic methods to
treat idiopathic low back pain: the oxygen-ozone therapy and the
diathermy through Tecar®therapy, associated with a standard
Physiokinesitherapy treatment.
Type of patients
We have recruited two groups made up of 10 patients each who suf-
fered from postural idiopathic low back pain due to pathologies caused
by lumbosacral intradiscal conflicts such as: disc bulging, lumbar pro-
trusion and discophaties.
Inclusion criteria
We have considered those patients with a medical diagnosis stating
disc bulging, protrusion or intradiscal conflict documented by CT or
NMR; patients aged between 25 and 70; the onset of symptoms not pre-
vious to 12 months.
Exclusion criteria
We have excluded from the study those subjects suffering from sys-
temic diseases (rheumatic diseases, osteoporosis, etc.); evident her-
nias; hernia recurrence; vertebral fractures; pseudosciatica.
Recruiting method
We have used the controlled random method. The names of those
patients showing homogeneous inclusion characteristics have been
put into individual anonymous envelops and then divided by the treat-
ment to examine by a third person who was unaware of the study under
consideration.
We evaluated 25 patients and then selected 20 of them, since 4 were
suffering from extruded hernia and 1 from pseudosciatica with piri-
formis muscle syndrome, therefore according to the exclusion criteria
they could not be admitted.
Work execution
Evaluation
Both groups have been evaluated before and after treatment by means
of Diers - Formetric 4D of the company Hako-Med Italia sas [Egna (BZ),
Italy], an instrument for the posture spinometric test and the analysis of
spine mechanical pathologies. The Formetric analysis system uses the
video rastereography, an innovative and very accurate method deter-
mined by the possibility to re-create, through a dedicated software, the
real tridimensional structure of the spine and to define automatically a
spatial ratio between dorsal morphology and bony skeleton.
Thanks to the Formetric vertebral morphology analysis system it is
no longer necessary to have recourse to the manual application of
markers since it automatically detects the reference marks, the median
line of the spine and its rotation.
Spinometry represents the result of the examination showing the
tridimensional model of the spine, with a representation of its mor-
phology and rotation with the addition of the pelvis position.
All patients selected according to the above-mentioned inclusion and
exclusion criteria, have been evaluated through spinometry and have
been given the Oswestry low back pain disability questionnaire to fill in
at the beginning of the treatments and at the end of them with a three-
month follow-up.
The Oswestry low back pain disability questionnaire
It consists in a percentage assessment scale of disabilities during the
daily activities caused by low back pain. The patient fills in a question-
naire divided into 10 sections made up of 5 multiple-choice answers
aimed at assessing: i) pain intensity; ii) personal care (to wash hands
and face, brush teeth, comb, shave and put on make-up, etc.); iii) manual
activities; iv) walking; v) staying seated; vi) standing; vii) sleeping; viii)
sexual activity; ix) public relations; x) moving and travelling.
Once the questionnaire has been filled up, the answers of the indi-
vidual sections are added up to obtain the final score which, there-
fore, can have a maximum of 50 scores. Such value is then multiplied
by two in order to get a percentage value corresponding to the disabil-
ity percentage.
The Formetric spinometry
It determines the tridimensional reconstruction of the spine by
using the triangulation and video rasterstereography principles with-
out emitting radiations.
According to the results of spinometric test, the ten data obtained by
each group after a comparison between the first and the last finding
with Formetric are evaluated, then it is performed a follow-up after
three months. The ten variables of the Formetric analysis taken into
consideration are: i) pelvic torsion; ii) righ surface rotation; iii) left
surface rotation; iv) maximum kyphotic angulation; v) maximum lor-
dotic angulation; vi) pelvic inclination; vii) right side deviation; viii)
left side deviation; ix) cervical curve; x) lumbar curve.
Method of analysis
We have processed data concerning the Oswestry percentages and
calculated their standard means and deviations, by availing ourselves
of the Student T statistic test to analyze the significance of differences
among the individual means.
In our analysis we made reference to T values by 18 degrees of free-
dom, using as threshold value of P-value the standard 0.05. In this case
T shall always be greater than 1.734 in order to consider the difference
among the means as significant (Table 1).
Instead, data obtained by Formetric findings during the first and the
last session, have been analyzed in both groups by comparing the
improvement, invariance and deterioration percentages of single pos-
tural components indicated by the spinometric test.
Comparison between treatment protocols
First group
To the patients of the first group, who have been selected with the
methods mentioned above, has been applied a diathermy treatment
through Tecar®therapy associated with a standard physio-kinesither-
apeutic treatment.
Second group
The second group’s patients were administered an oxygen-ozone
therapy treatment through a paravertebral lumbar infiltration associat-
ed with a standard physio-kinesitherapeutic treatment.
Diathermy through Tecar®therapy
Patients underwent 10 Pharon diathermy sessions by the company
Mectronic [Mectronic Medicale Srl, Grassobbio (BG), Italy] through
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Tecar®therapy and physiokinesitherapy twice a week, for five weeks
totally.
For the Tecar®therapy treatment we have used a stainless-steel
receiving plate with some conductive cream for diathermy from
Medisport applied on the patient’s abdominal region when laying in
prone position, on patient’s lumbar region we applied the same conduc-
tive cream to facilitate the transmitting electrode sliding.
Patients have been treated in capacitive mode for 8 min to an inten-
sity that allowed the patient to feel a warm sensation in the treated
area, we went on for other 8 min in resistive mode while trying again
to obtain the same sensation on the patient and finally one last 8-
minute session in capacitive mode.
Oxygen-ozone therapy
According to the oxygen-ozone therapy, we decided to follow the thera-
peutic protocol mentioned here below entailing paravertebral injections.
Applications have been administered once a week for the first three
weeks by decreasing the dose once every two weeks.
The oxygen-ozone infiltration has been performed in symmetric
areas of those paravertebral muscle masses near the hernia localiza-
tion, with a concentration of 18-20 µg/mL of ozone and a quantity equal
to 5 cc per site of inoculation, for a total of 4 paravertebral infiltrations
per session and of 6 sessions with infiltrations once a week for the first
3/4 weeks, and then every 2 weeks.
For the administration of oxygen-ozone we used Multiossigen srl
[Gorle (BG), Italy] machineries, in particular the Medical 99 IR and
Medical 98HCPS.
Results
In Figures 1 and 2 we report the charts showing the results obtained
by the Oswestry’s questionnaire administration.
By analyzing data collected by means of the Oswestry low back pain
disability questionnaire, it can be noticed that the improvement
occurred from the first to the last session for the two groups is similar.
Instead, the difference between the two results of follow-up changes
significantly (Figure 3): while the first group recorded 22.80% of dis-
ability, the second one remained at 12.40%, with a noticeable percent-
age gap equal to 10.40%. This means that the second group maintained
the obtained result over time with the treatment sessions.
Analyzing the data collected through the analysis with Formetric
spinometry it is possible to notice an improvement in both groups
under examination (Figures 4 and 5).
[Ozone Therapy 2016; 1:5842] [page 19]
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Table 1. Standard T distribution.
a
v 0.10 0.050 0.025 0.010 0.005
1 3.078 6.314 12.706 31.821 63.657
2 1.886 2.920 4.303 6.965 9.925
3 1.638 2.353 3.182 4.541 5.841
4 1.533 2.132 2.776 3.747 4.604
5 1.476 2.015 2.571 3.365 4.032
6 1.440 1.943 2.447 3.143 3.707
7 1.415 1.895 2.365 2.998 3.499
8 1.397 1.860 2.306 2.896 3.355
9 1.383 1.833 2.262 2.821 3.250
10 1.372 1.812 2.228 2.764 3.169
11 1.363 1.796 2.201 2.718 3.106
12 1.356 1.782 2.179 2.681 3.055
13 1.350 1.771 2.160 2.650 3.012
14 1.345 1.761 2.145 2.624 2.977
15 1.341 1.753 2.131 2.602 2.947
16 1.337 1.746 2.120 2.583 2.921
17 1.333 1.740 2.110 2.567 2.898
18 1.330 1.734 2.101 2.552 2.878
19 1.328 1.729 2.093 2.539 2.861
20 1.325 1.725 2.086 2.528 2.845
Figure 1. Percentage comparison, first group’s assessment scale.
Figure 2. Percentage comparison, second group’s assessment scale.
Figure 3. Comparison between the two results of follow-up.
Non-commercial use only
The improvement is greater in the second group, the one treated
with oxygen-ozone therapy associated with standard physiokinesither-
apy, for which the improvement data increase from 6% to 57%, against
those of the first group increasing from 20% to 38%.
Discussion and Conclusions
Data analyzed at the end of the two types of treatment and through
follow-up after three months showed the following results.
Through the Oswestry low back pain disability questionnaire we can
observe how patients belonging to the first group, the one that under-
went the therapy with diathermy through Tecar®therapy, have all
reported an improvement immediately after the therapeutic cycle.
This has been also confirmed by the spinometric tests performed, from
which it is possible to see that the majority of detected parameters showed
a real improvement in all patients, emphasized by the progressive normal-
ization, towards the normality range for the majority of data detected.
A similar situation can be observed for the second group treated with
oxygen-ozone therapy.
By analyzing the answers to the questionnaire the improvement has
been grater compared to the first one. Data pointed out with Formetric
show a marked improvement.
According to the comparison between the two therapeutic methods
used, from the results obtained by the questionnaire filling in and the
Formetric findings, we can observe the following:
- Patients treated with diathermy through Tecar®therapy achieved a
general improvement of 18.2% from the first to the last session and
a slight worsening comparable to 7% from the last session to the fol-
low-up performed after three months.
- Patients treated with oxygen-ozone therapy recorded a greater improve-
ment, equal to 21.8%, both from the first to the last session and during
the revaluation after three months, showing a worsening of only 3.2%.
Therefore we can assert that both methods produced positive
results for the majority of patients suffering from idiopathic low back
pain, however those who underwent diathermy show a greater wors-
ening upon follow-up compared to those who were treated with oxy-
gen-ozone therapy who preserve the beneficial effect of treatments
for a longer time.
We can conclude by saying that the work has corroborated the valid-
ity of both treatments that led to both a subjective and objective
improvement of symptomatology.
While one treatment leads to some relapses after a few months, the
second one has a greater healing effect, which preserves over time.
References
1. Mangone M. La Spinometria Formetric nella valutazione non inva-
siva delle deformità del rachide e del tronco. Congress on
Biomedical Products, La Sapienza University for HAKOMED Italia,
2010 May 8-9, Rome, Italy.
2. Kapandji IA. Fisiologia articolare. Vol. 3: Tronco e rachide. Milano:
Monduzzi Ed.; 1994.
3. Romano D. Spinometria, nuova frontiera per diagnosi e terapie.
Giorn Previdenza Med Odontoiatr 2008;10:24-5. Available from:
https://www.enpam.it/wp-content/uploads/10_2008.pdf
4. Benizet MP, Colmer JF. Tecarterapia nella patologia del ginocchio e
della colonna vertebrale; 2003. Available from: http://www.cmcon-
sulenze.it/pdf/tecar_evidenze_cliniche/patologia_ginocchio_colon
na_vertebrale.pdf
5. Chiefari M, Verde N, Salerno N, Luongo C. Efficacia antalgica del-
l’ozonoterapia. 6th SIOOT National Congress 1994, Rome, Italy.
6. Bertè F, Vairetti M, Richelmi P. Ozono: problemi tossicologici con
particolare riguardo alla formazione di radicali liberi’. 2nd SIOOT
National Congress 1990, Punta Ala (GR), Italy.
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Figure 4. Comparison of first group’s results. Figure 5. Comparison of second group’s results.
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