Efficacy of Selected Electrical Therapies On Chronic Low Back Pain: A Comparative Clinical Pilot Study

CLINICAL RESEARCH
e-ISSN 1643-3750
© Med Sci Monit, 2017; 23: 85-100
DOI: 10.12659/MSM.899461
Received: 2016.05.08
Accepted: 2016.05.17 Efficacy of Selected Electrical Therapies on
Published: 2017.01.07
Chronic Low Back Pain: A Comparative Clinical
Pilot Study
Authors’ Contribution: ABCDF 1 Joanna Rajfur 1 Institute of Physiotherapy, Public Higher Medical Professional School in Opole,
Study Design A ACD 1 Małgorzata Pasternok Opole, Poland
Data Collection B 2 Department of Sports Training, Academy School of Physical Education in Wrocław,
Analysis C
Statistical BCD 1 Katarzyna Rajfur Wroclaw, Poland

Data Interpretation D CDEF 1 Karolina Walewicz 3 Department of Nervous System Diseases, Wrocław Medical University, Wrocław,
Manuscript Preparation E BD 1 Beata Fras Poland
Literature Search F 4 Department of Physiotherapy Basics, Academy School of Physical Education in
Collection G
Funds CD 2 Bartosz Bolach Katowice, Katowice, Poland
DEFG 3 Robert Dymarek
EFG 3 Joanna Rosinczuk
ACDG 1 Tomasz Halski
ABCDEFG 4 Jakub Taradaj
Corresponding Author: Jakub Taradaj, e-mail: [email protected]

Source of support: Departmental sources
Background: In the currently available research publications on electrical therapy of low back pain, generally no control groups
or detailed randomization were used, and such studies were often conducted with relatively small groups of
patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement meth-
ods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale
clinical study. The purpose of this study was to assess the effects of treating low back pain using selected elec-
trotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduc-
tion of pain, improvement of the range of movement in lower section of the spine, and improvement of mo-
tor functions and mobility.
Material/Methods: The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6
comparison groups: A – conventional TENS, B – acupuncture-like TENS, C – high-voltage electrical stimulation,
D – interferential current stimulation, E – diadynamic current, and F – control group.
Results: The research showed that using electrical stimulation with interferential current penetrating deeper into the
tissues results in a significant and more efficient elimination of pain, and an improvement of functional abili-
ty of patients suffering from low back pain on the basis of an analysis of both subjective and objective param-
eters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents
appears to be useless.
Conclusions: Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating
chronic low back pain.
MeSH Keywords: Electric Stimulation • Low Back Pain • Physical Therapy Specialty
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Rajfur J. et al.:
CLINICAL RESEARCH Electrical therapy for low back pain
© Med Sci Monit, 2017; 23: 85-100
Background of 13 December 2012). The study included patients with low

back pain, referred for physical therapy to the Clinical Research
The basic method of treatment for chronic low back pain is Lab of the Public Higher Medical Professional School in Opole,
conservative treatment, consisting of pharmacotherapy, kine- Poland.
siotherapy, and physical therapy treatments. Dynamic devel-
opment of biomedical engineering results in new technical Qualification of patients was made by a team composed of
solutions applied in creating new medical devices. The devic- an orthopedist, a neurologist, a neurosurgeon, an internist,
es that are currently used in physical therapy treatments sup- a radiologist, and a physiotherapist. Selection of patients for
port, and at times even replace, pharmacological treatment participation in the study was purposeful. Patients qualified
methods. In addition, due to their rare adverse effects, physi- for the study suffered from the L5-S1 discopathy, chronic ra-
cal methods shorten treatment period, improve quality of life, diating pain, and pseudoradicular syndrome, and had no pre-
and reduce therapy costs. One of the physical treatments most vious surgical procedures within the spinal area. The patients
frequently used in back pain syndromes is electrical therapy. were at least 18 years old and had valid certificates of the MRI
The main goal of using electrical stimulation in treating low examination, confirming the diagnosis of low back pain syn-
back pain syndromes is an attempt to alleviate both pain and drome (at least type III° changes in accordance with the Modic
inflammation, as well as to reduce muscle tension in the af- classification in the L5–S1 spine section). On the other hand,
fected regions [1–3]. the allocation of patients who positively underwent the qual-
ification procedure to specific groups was random (based on
However, on the basis of analysis of the available literature a computer number generator). Patients were assigned to 6
on electrotherapeutical methods of low back pain treatment, comparison groups.
most studies fail to meet the basic criteria of “evidence-based
physiotherapy”, which makes it extremely difficult to carry out Inclusion and exclusion criteria
a clear and objective analysis of clinical efficacy of treatments
that are widely used in everyday practice. Exclusion criteria referred to patients who were diagnosed with:
acute pain (less than 6 months), the radicular syndrome, dis-
In the currently available research publications on electrical copathy of other spine regions (patients with early type I and
therapy of low back pain, generally no control groups or de- II° changes were not excluded from the study, only the type
tailed randomization were used, and such studies were often III° degeneration, as per the Modic classification, constituted
conducted with relatively small groups of patients, based sole- grounds for exclusion), no pain or reduction of mobility in the
ly on subjective questionnaires and pain assessment scales lumbosacral section, other disorders of the spine (spondylolis-
(lacking measurement methods to objectify the therapeutic thesis, fractures, tumors, rheumatic diseases, the cauda equina
progress). The available literature also lacks any comprehen- syndrome), pregnancy, defect symptoms, cardiovascular dis-
sive and large-scale clinical study analyzing clinical efficacy of eases, pacemakers, metal implants within the application area,
the numerous electrotherapeutic methods popular in physio- sensory disorders, mental disorders, cancer, skin lesions with-
therapy in a single study, with consistent statistical calcula- in the area of application of the electrodes, psoriasis, sclero-
tions, which would allow for a reliable assessment of the stud- derma, and viral or bacterial infections. Patients who had un-
ied treatments and their comparison to one another, and in dergone spinal surgery, as well as those taking painkillers or
relation to a representative control group [4]. anti-inflammatory drugs, were also excluded from the study.
Exclusion criteria referred also to patients with damage to the
Therefore, the aim of this study was to assess the effects of vestibule and/or a part of the vestibulocochlear nerve, with
treating low back pain using selected electrical therapies. The Ménière syndrome, vestibular neuritis, sudden loss of function
study assesses the influence of individual electrotherapeutic of the inner ear, as well as damage to the cerebellum, spinal
treatments on reduction of pain, improvement of the range cord and brainstem, resulting in balance disorders.
of movement in lower section of the spine, and improvement
of motor functions and mobility. Interventions’ characteristics
A total of 127 patients were qualified for the therapy (ulti-

Material and Methods mately, 124 patients completed the study) and assigned to 6
comparison groups (a flow diagram is presented in Figure 1).
Patients’ qualification Group A consisted of 20 patients (all participants in this group
completed the entire study program). Patients were treated
The research project was approved by the Bioethics Commission with the transcutaneous electrical nerve stimulation (conven-
of the Academy of Physical Education in Katowice (no. 10/2012 tional TENS). Treatment parameters were: alternating current,
Rajfur J. et al.:
Electrical therapy for low back pain
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Assessed for eligibility (n=238)
Excluded (n=111)
• Not meeting inclusion criteria (n=103)
• Declined to participate (n=7)
• Other reasons (n=1)
Randomized (n=127)
Conventional TENS Acupunture like TENS HVES Inteferential current Diadynamic current Control
Allocated to Allocated to Allocated to Allocated to Allocated to Allocated to

intervention (n=20), intervention (n=20), intervention (n=22), intervention (n=22), intervention (n=22), intervention (n=21),
received allocated received allocated received allocated received allocated received allocated received allocated
intervention (n=20) intervention (n=20) intervention (n=20) intervention (n=21) intervention (n=22) intervention (n=21)
Figure 1. Flow diagram of the study.
rectangular impulse, impulse duration 100 µs, frequency of Group D initially consisted of 22 patients, but 1 person had to
100 Hz, subjective dosage (until a distinctive sensation of the resign from further therapy due to aggravation of symptoms
current flow was experienced, during the patient’s habitua- and started taking analgesics. Eventually, 21 patients complet-
tion to the electrical stimulus, the therapist gradually increased ed the therapy. Subjects in group D were treated with electro-
the intensity during treatment to maintain the desired sensa- therapy using medium-frequency currents (interferential current
tions), and 60-min duration of a single treatment. stimulation). Treatment parameters were: alternating current,
sinusoidal impulse, impulse duration 100 µs, basic frequen-
Group B consisted of 20 patients (as in the previous group, cy 4000 Hz, alternating frequency 50–100 Hz, subjective dos-
all the patients completed the therapy). Patients were treat- age (until a distinctive sensation of the flowing current was
ed with the transcutaneous electrical nerve stimulation (acu- experienced, during the patient’s habituation to the electrical
puncture-like TENS). Treatment parameters were: alternating stimulus, the therapist gradually increased the intensity dur-
current, rectangular impulse, impulse duration 200 µs, fre- ing treatment to maintain the desired sensations), and 20 min
quency of 10 Hz, subjective dosage (until distinctive muscle duration of a single treatment.
contraction, during habituation and decrease of the motion
effect, the therapist gradually increased the intensity during Group E consisted of 22 patients. Patients in this group
treatment to maintain the desired muscle stimulation thresh- were treated with electrotherapy using diadynamic currents.
old), and 60-min duration of a single treatment. Treatment parameters were: pulsed current, sinusoidal impulse,
impulse duration and frequency (sequentially DF 10 ms, 100
Group C initially consisted of 22 patients, but 2 participants Hz, CP 10 ms, 50–100 Hz, LP 10 ms, 50–100 Hz, but with an
withdrew from further therapy due to viral infection and did alternating amplitude), subjective dosage (until a distinctive
not complete the treatment series (1 participant resigned af- sensation of the flowing current is experienced, during the pa-
ter 4 sessions and the other after 6 sessions). One person had tient’s habituation to the electrical stimulus the therapist grad-
to discontinue the therapy after 3 sessions due to the occur- ually increased the intensity during treatment to maintain the
rence of skin lesions within the area of application of the elec- desired sensations), and 9-min duration of a single treatment
trodes. In total, group C consisted of 19 patients. These pa- (DF, LP, and CP were 3 min each).
tients were treated using high-voltage electrical stimulation.
Treatment parameters were: output voltage 100 V, alternating In all patients treated with physical therapy, the electrodes
current, spike impulse, impulse duration 100 µs, frequency of were placed in the lumbar region in the posterior axillary line
100 Hz, subjective dosage (until a distinctive sensation of the (Figures 2, 3).
current flow was experienced, during the patient’s habituation
to the electrical stimulus, the therapist gradually increased in- However, patients in group F (21 patients, control group) were
tensity during treatment to maintain the desired sensations), treated only by means of motor improvement exercises. The sta-
and 50-min duration of a single treatment. bilization training [5–7] included: myofascial release techniques
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
Figure 2. E
lectrode placement in both TENS, HVES, and Figure 3. Electrode placement in Inteferiantial current group.
diadynamic current groups.
for the erector spinae muscle, activation techniques for the The VAS (Visual Analogue Scale) pain assessment scale was
neutral position of the lumbo-pelvic-hip complex and deep used for subjective assessment of the experienced pain, in
muscles, training the activation of proper breathing and the which the patient assesses the experienced pain on a simple
transversus abdominis muscle, exercising the coordination of scale from 0 to 10, where 0 denotes lack of pain and 10 de-
superficial and deep trunk muscles, and postural and dynam- notes the strongest pain.
ic training. Duration of a training session was 45 min (5 times
a week, from Monday to Friday). The modified Laitinen pain scale was used to assess 4 indica-
tors: pain intensity, frequency of pain occurrence, use of an-
In the comparison groups A, B, C, D, and E, patients treated algesics, and limitations of mobility.
with electrical therapy performed basic therapy exercises in
accordance with the same methodology as patients in group The Oswestry questionnaire (The Oswestry Low Back Pain
F. Patients in all the comparison groups (with the exception Disability Questionnaire, Oswestry Disability Index [ODI]) was
of group F, in which only the daily motor improvement exer- used to evaluate the functional ability of patients; it is a wide-
cises were used for 3 weeks) were subjected to a series of ly recognized and reliable scale for evaluation of patients with
15 treatments, 5 times a week (Monday to Friday) for a pe- low back pain. The questionnaire consists of 10 questions re-
riod of 3 weeks. garding symptoms and everyday activities. When answer-
ing the individual questions, the patient can choose 1 of the
The treatments were performed with the Ionoson Expert cur- 6 options scored from 0 to 5: A – 0 points; B – 1 point; C – 2
rent generators (Physio Med Electromedizin, Germany), which points; D – 3 points; E – 4 points; F – 5 points. After summing
were calibrated before treatment of each patient using the mea- the scores for all questions, the Oswestry disability index is
surement system and the serial connection of the Ionoson de- as follows: no disability (0–4 points); minimal disability (5–14
vice to a cathodal oscilloscope and a decade resistor (electrical points); moderate disability (15–24 points); severe disability
circuit loaded with the resistance of 10 kΩ, as the average re- (25–34 points); and full disability (35–50 points).
sistance of the human body) in order to verify the repeatabil-
ity, durability, and stability of the treatment parameters gen- The Roland-Morris Disability Questionnaire (RM) was used to
erated by the electrostimulator. assess the degree of disability in patients with low back pain
and reflects the condition of the patient on the day of the ex-
Patients in all the comparison groups were homogeneous in amination. The questionnaire contains 24 questions which are
terms of basic characteristics specific for the studied popula- answered yes or no. Each yes answer scores 1 point and each
tions (Table 1). The groups were also homogeneous as regards no answer scores 0 points. After summing the scores for all
the initial measurements concerning pain assessment, func- questions, the Roland-Morris disability index is as follows: no
tional state, mobility range, and body posture. disability (0–3 points); minimal disability (4–10 points); mod-
erate disability (11–17 points); severe disability (18–24 points).
Pain measurements and functional testing
The Lasègue test was used to measure the mobility range in
In order to analyze the therapeutic progress for the subjec- the hip joint on the side of the herniated disc in the course of
tive assessment of pain and functional capacity as well as spinal discopathy. The starting position is lying down on the
the assessment of the degree of disability, the following tests back with both legs straight. The examiner then slowly lifts
were performed: one of the patient’s legs while the knee is straight at the joint,
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Table 1. Characteristic of study population in each group.
Group A Group B Group C Group D Group E Group F p – value
Gender (n)
Female 11 12 11 13 13 13
>0.05
Male 9 8 8 8 9 8
Age (years)
Mean 50.23 52.11 47.75 48.67 52.11 49.77
SD 16.34 17.03 14.84 15.19 17.21 13.67 >0.05
Min÷maks 18-70 24-76 32-68 29-70 19-73 35-67
Hight (cm)
Mean 172.11 170.34 169.08 169.26 173.21 167.22
>0.05
SD 9.21 8.88 8.36 8.45 10.13 7.89
Body mass (kg)

Mean 76.24 77.89 75.13 76.21 78.23 73.67
>0.05
SD 11.89 10.67 10.49 10.03 12.21 8.34
BMI (kg/m2)
mean 26.67 27.03 26.31 26.11 25.89 26.09
>0.05
SD 3.89 3.93 3.71 3.45 4.01 3.14
Obesity (n)
BMI>30 kg/m2 6 5 5 6 5 4 >0.05
Disease duration (years)

Mean 4.04 3.78 3.64 3.88 4.02 3.87
>0.05
SD 3.88 3.67 3.38 3.78 3.87 3.69
Osteoarthritis (n)
Right side 13 14 12 11 12 11
>0.05
Left side 7 6 7 10 10 10
Radiological changes in Modic

classification (n)
14 15 14 15 16 14
III° >0.05
6 5 6 6 6 7
IV°
Pain intensity in VAS (score)

Mean 7.69 7.72 7.37 7.56 7.29 7.34 >0.05
SD 1.34 1.35 1.28 1.53 1.66 1.57
Pain intensity in Laitinen (score)

Mean 8.64 8.69 8.21 8.19 8.17 8.19 >0.05
SD 2.01 1.79 1.67 1.73 1.88 2.07
Disability level in Oswestry (score)

Mean 35.11 34.95 33.04 32.88 34.33 34.30
>0.05
SD 5.22 5.01 4.88 4.64 4.96 5.07
Disability level in Roland-Morris

(score)
14.05 13.97 13.83 13.71 13.86 13.83
Mean >0.05
2.11 2.07 2.17 2.32 2.16 2.07
SD
Body posture in coronal plane (mm)

Mean 192.11 190.88 190.25 192.08 190.25 189.92 >0.05
SD 45.33 42.11 42.13 41.21 39.78 42.75
Body postuare in sagittal plane (mm)

Mean 134.33 135.21 134.00 135.66 133.45 134.00
>0.05
SD 34.66 32.00 36.47 41.21 39.89 38.55
SD – standard deviation; min÷maks – minimal ÷ maximal values.
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
until pain occurs. The mobility range is measured in angle de-

grees using a goniometer.
The Schober test was used for evaluation of mobility of the

lumbosacral spine. While the patient is in a standing position,
the examiner marks 2 points on the patient’s skin: at 10 cm
above the line connecting the posterior superior iliac spines,
and then at 5 cm below that line. The patient then slowly bends
down as far as possible, while keeping the knees straight. The
measurement is made using a tape measure. The obtained re-
sult is recorded with an accuracy of up to 0.5 cm.
The mobility range measurements were carried out by the same

technician (each measurement was an arithmetic mean of 5
trials). For the purposes of this clinical study, a self-estima-
tion of error of the person performing the measurements was
calculated. For each of 15 randomly selected participants, 20
more measurements were taken using the Lasègue test and
the Schober’s test (600 measurements in total).
The absolute measurement error (DX) was calculated using

the formula:
DX=X–X0, where X – value measured at the subsequent trial,

X0 – correct (mean) value calculated after 20 trials.
Then the relative error (dX) was estimated, using the formula:
dX=DX/X0, where DX – absolute error, X – value measured at

a given trial.
Figure 4. Stabilometric platform measurement method.
The mean percentage error (relative error expressed in per-
centage points) was then calculated for all the 20 measure- their bodies, head facing forward, with eyes fixed on a desig-
ments for the Lasègue and Schober tests. The resulting mea- nated point placed at eye level about 1.5 m away) (Figure 4).
surement error, in accordance with the proprietary calculations,
was as follows: the arithmetic mean of the measurement er- Statistical analyses of the basic posturographic parameters
ror was 5.88%, and the standard deviation was 3.73% for the were performed to compare balance conditions in the tested
Lasègue test, and the mean was 3.45%, and the standard de- group of patients. The following parameters were analyzed:
viation was 1.04% for the Schober test. All pain measurements
and functional testing were applied before and after treatment. total path length [mm], i.e. the total sway of the center of pres-
sure of the subject’s feet during the trial (30 s), in millimeters;
Stabilometric platform measurements anterio/posterior path length [mm]; medio/lateral path length
[mm]; mean amplitude (radius) [mm]; and mean anterio/pos-
An objective measurement tool for evaluating postural stabil- terior amplitude [mm].
ity was used. The evaluation was performed using a double-
plate stabilographic platform equipped with a computer-aided The above postural stability tests were carried out both before
posturographic system, manufactured by CQ Elektronik System the therapy process and after its completion.
(Poland), model CQ Stab2P. The measurement error was 0.86%.
For each patient, 2 trials were carried out: the first trial with Statistical analysis
eyes open in full visual control, and the second trial with eyes
closed, without visual control. The subjects were in a habitu- The studied parameters were analyzed using the STATISTICA
al, upright position, standing barefoot on the posturographic statistical software ver. 10.0 (StatSoft, Dell Inc., USA). The homo-
platform (feet apart in line with their hips, arms down along geneity of distribution of patients’ characteristics in all groups
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Table 2. Intragroup comparisons of the pain intensity changes in VAS scoring before and after treatment [score].
Before treatment After treatment p-value

Mean 7.69 2.05
Group A 0.00015
SD 1.34 0.45
Mean 7.72 2.11
Group B 0.00015
SD 1.35 0.34
Mean 7.37 1.85
Group C 0.00015
SD 1.28 0.24
Mean 7.56 0.97
Group D £0.0001
SD 1.53 0.31
Mean 7.29 4.05
Group E 0.0012
SD 1.66 0.78
Mean 7.34 4.11
Group F 0.0012
SD 1.57 0.69
VAS – visual-analogue scale; SD – standard deviation.
Table 3. Intragroup comparisons of the pain intensity changes in Laitinen scoring before and after treatment [score].

Mean 8.64 3.19
Group A 0.00014
SD 2.01 1.13
Mean 8.69 3.25
Group B 0.00016
SD 1.79 1.12
Mean 8.21 2.87
Group C 0.00014
SD 1.67 0.89
Mean 8.19 1.11
Group D £0.0001
SD 1.73 0.51
Mean 8.17 3.69
Group E 0.0021
SD 1.88 1.18
Mean 8.19 3.74
Group F 0.002
SD 2.07 1.22
SD – standard deviation.
was analyzed with the chi-square test in the highest reliabil- Results
ity version (c2) and the Kruskal-Wallis homogeneity test. The
statistical significance was set at p<0.05. For dependent vari- Analysis of results regarding the influence of electrical
ables, the nonparametric Wilcoxon’s matched pairs test was therapy on the subjective experience of spinal pain
used, and for independent variables we used the nonpara-
metric Kruskal-Wallis variance analysis. The Tukey post hoc After completion of the therapy, all the comparison groups
multiple comparisons test was used to identify the exact de- demonstrated a statistically significant reduction of pain as
pendencies resulting from the variance analysis between in- compared to the initial values, measured using the VAS scale
dividual groups. The statistical significance was set at p<0.05. (Table 2). Similarly, a subjective reduction of pain was record-
ed using the Laitinen questionnaire (Table 3).
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
VAS scoring [%] Latinen scoring [%]

100.00 90.00
90.00 80.00 84.07
80.00 88.03
70.00
70.00 74.31 74.28 74.56 60.00 63.99 63.89 64.87
60.00 50.00 54.34 54.21
50.00
46.12 46.90 40.00
40.00
30.00
30.00
20.00 20.00
10.00 10.00
0.00 0.00
Group A Group B Group C Group D Group E Group F Group A Group B Group C Group D Group E Group F
Figure 5. Intergroup comparisons of the pain intensity reduction Figure 6. Intragroup comparisons of the pain intensity reduction
in VAS scoring [%]. P (A,B,C,D,E,F)=0.034. Post hoc in Laitinen scoring [%]. P (A,B,C,D,E,F)=0.026. Post
analysis: p(A,B)>0.05; p(A,C)>0.05; p(A,D)=0.041; hoc analysis: p(A,B)>0.05; p(A,C)>0.05; p(A,D)=0.018;
p(A,E)=0.014; p(A,F)=0.016; p(B,C)>0.05; p(B,D)=0.038; p(A,E)=0.044; p(A,F)=0.044; p(B,C)>0.05; p(B,D)=0.018;
p(B,E)=0.012; p(B,F)=0.012; p(C,D)=0.045; p(C,E)=0.012; p(B,E)=0.045; p(B,F)=0.044; p(C,D)=0.018; p(C,E)=0.045;
p(C,F)=0.012; p(D,E)=0.001; p(D,F)=0.001; p(E,F)>0.05. p(C,F)=0.045; p(D,E)=0.001; p(D,F)=0.001; p(E,F)>0.05.
Table 4. Intragroup comparisons of the disability level changes in Oswestry scoring before and after treatment [score].
Mean 35.11 22.05

Group A 0.00017
SD 5.22 3.19
Mean 34.95 21.87

Group B 0.00022
SD 5.01 3.21
Mean 33.04 19.95

Group C 0.00022
SD 4.88 3.07
Mean 32.88 12.05

Group D £0.0001
SD 4.64 2.71
Mean 34.33 26.05

Group E 0.0014
SD 4.96 3.43
Mean 34.30 26.01

Group F 0.0014
SD 5.07 3.87
However, the intergroup analysis demonstrated that the high- Analysis of results regarding the influence of electrical
est analgesic effect was recorded in group D (interferential therapy on the subjective experience of functional ability
current stimulation), which proved to be a significantly better in patients with low back pain
result than in groups A (conventional TENS), B (acupuncture-
like TENS), and C (high-voltage electrical stimulation [HVES]). After 3 weeks of treatment, all the comparison groups dem-
No statistically significant differences were observed between onstrated a statistically significant improvement of functional
groups A, B, and C. The lowest analgesic effect was observed ability, measured using the Oswestry questionnaire (Table 4).
in group E (diadynamic currents [DD]) and F (control group), at Similarly, a subjective improvement of patients’ ability was re-
a similar level in both groups. The above was confirmed both corded using the Roland-Morris questionnaire (Table 5).
by the results of measurements performed using the VAS scale
(Figure 5) and the Laitinen questionnaire (Figure 6). However, on the basis of an intergroup analysis, we found that
the highest percentual improvement of the patients’ functional
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Table 5. Intragroup comparisons of the disability level changes in Roland – Morris scoring before and after treatment [score].
Mean 14.05 4.88

Group A 0.00055
SD 2.11 1.34
Mean 13.97 3.69

Group B 0.00046
SD 2.07 1.11
Mean 13.83 4.64

Group C 0.0005
SD 2.12 1.27
Mean 13.71 2.03

Group D £0.0001
SD 2.32 0.91
Mean 13.86 5.88

Group E 0.0012
SD 2.16 1.67
Mean 13.83 5.80

Group F 0.001
SD 2.07 1.72
Oswestry scoring [%] Roland-Morris scoring [%]

70.00 90.00
60.00 80.00 82.88
62.59 70.00
50.00 66.01 65.78 66.23
60.00
40.00 50.00 57.26 57.19
39.23 40.03 39.91
30.00 40.00
30.00
20.00 24.12 23.99
20.00
10.00 10.00
0.00 0.00
Figure 7. Intergroup comparisons of the disability level Figure 8. Intergroup comparisons of the disability level
diminishment in Oswestry scoring [%]. P diminishment in Roland-Morris scoring [%].
(A,B,C,D,E,F)=0.012. Post hoc analysis: p(A,B)>0.05; p(A,B,C,D,E,F)=0.055 (close to the significant level). Post
p(A,C)>0.05; p(A,D)=0.028; p(A,E)=0.036; p(A,F)=0.036; hoc analysis: p(A,B)>0.05; p(A,C)>0.05; p(A,D)=0.035;
p(B,C)>0.05; p(B,D)=0.031; p(B,E)=0.037; p(B,F)=0.038; p(A,E)>0.05; p(A,F)>0.05; p(B,C)>0.05; p(B,D)=0.038;
p(C,D)=0.028; p(C,E)=0.038; p(C,F)=0.038; p(D,E)=0.001; p(B,E)>0.05; p(B,F)>0.05; p(C,D)=0.033; p(C,E)>0.05;
p(D,F)=0.001; p(E,F)>0.05. p(C,F)>0.05; p(D,E)=0.037; p(D,F)>0.05; p(E,F)>0.05.
ability measured with the Oswestry questionnaire took place (interferential current stimulation). In the remaining groups,
in group D (interferential current stimulation), giving a signif- the results were significantly statistically worse (Figure 8).
icantly more beneficial effect than in groups A (conventional
TENS), B (acupuncture-like TENS), and C (HVES). No statisti- Analysis of results regarding the influence of electrical
cally significant differences were observed between groups A, therapy on hip mobility range on the affected side and in
B, and C. The lowest effect was observed in group E (DD) and the low back region
F (control group), at a similar level in both groups (Figure 7).
Immediately after completion of therapy, the comparison groups
In case of intergroup comparisons regarding the subjective demonstrated a statistically significant increase of mobility
experience of ability measured with the Roland-Morris ques- in the hip joint as compared to the pre-therapy state, mea-
tionnaire, the greatest progress was observed in group D sured using the Lasègue test (Table 6). An improved mobility
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
Table 6. Intragroup comparisons of the hip join mobility changes in Lasègue testing before and after treatment [degree].
Mean 56.70 69.10

Group A 0.0011
SD 7.40 10.80
Mean 56.55 68.95

Group B 0.0012
SD 7.25 10.30
Mean 58.80 71.70

Group C 0.0012
SD 7.70 10.20
Mean 58.65 80.50

Group D £0.0001
SD 7.35 10.45
Mean 59.80 65.55

Group E 0.0036
SD 7.10 10.75
Mean 59.70 64.50

Group F 0.0037
SD 7.55 9.95
Table 7. Intragroup comparisons of the lower Th mobility changes in Schober testing before and after treatment [cm].
Mean 3.25 4.50

Group A 0.0032
SD 1.55 3.35
Mean 3.20 4.45

Group B 0.0032
SD 1.45 3.45
Mean 3.30 4.60

Group C 0.003
SD 1.75 4.15
Mean 3.35 5.10

Group D 0.0016
SD 1.35 4.85
Mean 3.45 4.05

Group E 0.0044
SD 1.40 3.70
Mean 3.40 4.05

Group F 0.0044
SD 1.55 3.70
in the low back region was also recorded in the Schober’s The least progress was recorded in group E (DD) and F (control
test (Table 7). group), at a similar level in both groups (Figure 9).
On the basis of an intergroup analysis, we found that the high- The comparison of intergroup results of the Schober’s test indi-
est percentual improvement in the Lasègue test took place in cated that groups A (conventional TENS), B (pseudo-acupunc-
group D (interferential current stimulation), giving a signifi- ture TENS), C (HVES), and D (interference currents) gained a
cantly better result than in groups A (conventional TENS), B significant advantage over groups E (DD) and F (control group)
(acupuncture-like TENS), and C (HVES). No statistically signif- (Figure 10).
icant differences were observed between groups A, B, and C.
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Lasègue testing [%] Schober testing [%]

30.00 35.00
30.00 32.76
25.00 26.12
28.08 28.12 28.78
25.00
20.00
17.78 18.01 18.08 20.00
15.00
15.00
10.00 10.00 12.87 12.93
7.68 7.76
5.00 5.00
0.00 0.00
Figure 9. Intergroup comparisons of the hip join Figure 10. Intergroup comparisons of the lower Th
mobility improvement in Lasègue testing [%]. mobility improvement in Schober testing [%].
p(A,B,C,D,E,F)=0.031. Post hoc analysis: p(A,B)>0.05; p(A,B,C,D,E,F)=0.036. Post hoc analysis: p(A,B)>0.05;
p(A,C)>0.05; p(A,D)=0.041; p(A,E)=0.018; p(A,F)=0.018; p(A,C)>0.05; p(A,D)>0.05; p(A,E)=0.018; p(A,F)=0.020;
p(B,C)>0.05; p(B,D)=0.043; p(B,E)=0.017; p(B,F)=0.018; p(B,C)>0.05; p(B,D)>0.05; p(B,E)=0.015; p(B,F)=0.016;
p(C,D)=0.046; p(C,E)=0.018; p(C,F)=0.018; p(D,E)=0.001; p(C,D)>0.05; p(C,E)=0.018; p(C,F)=0.014; p(D,E)=0.008;
p(D,F)=0.001; p(E,F)>0.05. p(D,F)=0.008; p(E,F)>0.05.
Table 8. Intragroup comparisons of the SP parameter changes in stabilometric examination with open and closed eyes before
and after treatment [mm].
Open eyes Closed eyes
Before After p-value Before After p-value

treatment treatment treatment treatment
Mean 192.11 185.34 267.89 255.88

Group A 0.011 0.0042
SD 45.33 27.22 56.77 39.05
Mean 190.88 184.02 268.44 257.73

Group B 0.01 0.0043
SD 42.11 22.87 55.33 34.11
Mean 190.25 183.66 267.33 258.33

Group C 0.011 0.0042
SD 42.13 24.83 58.16 37.28
Mean 192.08 172.27 266.92 234.33

Group D 0.0012 0.00078
SD 41.21 20.75 49.34 34.21
Mean 190.25 185.12 268.05 260.18

Group E 0.011 0.0047
SD 39.78 21.79 50.44 39.66
Mean 189.92 186.05 267.21 259.15

Group F 0.011 0.0047
SD 42.75 23.32 46.99 35.62
SP – total path length on both coronal (left/right) and sagittal (front/back) axes [mm]; SD – standard deviation.
Analysis of the results regarding the influence of electrical of the center of pressure during a time trial (Table 8) and the
therapy on body posture parameters measured using the path length in the anterio-posterior sway (Table 9) in compar-
stabilometric platform ison to the initial state. These parameters were significantly
reduced in all the comparison groups (in particular with eyes
After completion of therapy, tests on the stabilometric plat- closed), which confirms that patients with low back pain had
form clearly demonstrated a statistically significant improve- a more stable body posture after the therapy. In case of mea-
ment in body posture as regards the total path length of sway surement of the path in the lateral sway, a beneficial reduction
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
Table 9. Intragroup comparisons of the SPAP parameter changes in stabilometric examination with open and closed eyes before and
after treatment [mm].

Mean 134.33 124.33 213.12 206.89

Group A 0.022 0.031
SD 34.66 20.12 66.66 40.85
Mean 135.21 126.50 214.11 207.66

Group B 0.022 0.032
SD 32.00 20.80 67.33 45.45
Mean 134.00 125.50 212.33 206.33

Group C 0.02 0.03
SD 36.47 22.09 63.73 43.80
Mean 135.66 120.33 212.50 200.50

Group D 0.0018 0.0012
SD 41.21 20.75 58.88 45.34
Mean 133.45 124.50 212.33 205.78

Group E 0.025 0.036
SD 39.89 22.50 62.56 44.44
Mean 134.00 125.12 213.01 206.87

Group F 0.025 0.036
SD 38.55 27.20 66.09 45.88
SPAP – statokinesiogram path length on the sagittal plane (front/back) [mm]; SD – standard deviation.
Table 10. Intragroup comparisons of the SPML parameter changes in stabilometric examination with open and closed eyes before and

Mean 109.00 104.33 118.88 113.21

Group A >0.05 >0.05
SD 21.34 14.12 13.56 9.78
Mean 108.35 103.50 119.64 112.76

Group B >0.05 >0.05
SD 23.12 14.57 14.55 9.89
Mean 108.33 104.00 119.83 112.83

Group C >0.05 >0.05
SD 22.04 15.82 14.95 9.74
Mean 109.50 105.50 119.34 112.03

Group D >0.05 >0.05
SD 20.11 15.05 14.22 10.04
Mean 108.50 104.50 118.03 113.12

Group E >0.05 >0.05
SD 21.44 16.53 13.89 10.12
Mean 109.30 105.33 118.23 114.02

Group F >0.05 >0.05
SD 23.11 14.09 15.36 10.37
SPML – statokinesiogram path length on the coronal plane (left/right) [mm]; SD – standard deviation.
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
Table 11. Intragroup comparisons of the MA parameter changes in stabilometric examination with open and closed eyes before and

Mean 1.61 1.57 3.15 2.92

Group A >0.05 0.022
SD 0.74 0.63 1.56 1.24
Mean 1.60 1.58 3.17 2.96

Group B >0.05 0.024
SD 0.70 0.65 1.43 1.75
Mean 1.60 1.58 3.18 2.95

Group C >0.05 0.023
SD 0.71 0.65 1.48 1.20
Mean 1.61 1.57 3.18 2.80

Group D >0.05 0.0013
SD 0.77 0.60 1.47 1.56
Mean 1.60 1.59 3.17 2.94

Group E >0.05 0.021
SD 0.76 0.64 1.37 1.44
Mean 1.59 1.57 3.17 2.95

Group F >0.05 0.021
SD 0.72 0.68 1.49 1.78
MA – the mean amplitude (radius) of the centre of pressure, on both axes [mm]; SD – standard deviation.
was also recorded in the studied groups, although these chang- remaining groups, the phenomenon occurred with a slightly
es were not statistically significant (Table 10). lower intensity. However, no statistically significant differenc-
es were found between the studied groups. The situation was
Interesting changes occurred in measurements of the mean identical in the eyes-closed test.
radius of the center of pressure sway, as the beneficial reduc-
tion of this parameter and improvement of postural stability On the other hand, in the percentage analysis of reduction of
took place in the closed-eyes trial (Table 11). In trials under the mean radius of center of pressure sway in trials under visu-
visual control, the radius was also reduced in all groups, but al control, there were no significant changes, and the recorded
this change was significantly smaller. changes occurred at a similar level in all groups. Interestingly,
in the eyes-closed trial, patients in group D (interferential cur-
Similar tendencies were also observed for other stabilometric rent stimulation) had better scores than those obtained in oth-
parameters. The analysis of variance showed that the greater groups. However, no statistically significant differences were
est percentual reduction in the length of the total path of the detected, although an evident trend was observed regarding
center of pressure sway in a time trial occurred in group D (in- changes in benefit of group D in relation to the other groups.
terference currents). These parameters were also slightly re-
duced in the remaining groups, especially group A (conven- Observation of the percentual reduction of the mean lateral
tional TENS), B (acupuncture-like TENS), and C (HVES), but sway of the center of pressure in the eyes-open trial did not
despite this trend, no statistically significant difference was show a visible improvement of this parameter in the studied
obtained in relation to groups E (DD) and F (control group). A groups (reduction of sway was small and occurred at a simi-
similar situation was observed in the case of closed-eyes tri- lar level in all patients irrespectively of the treatment meth-
al, where group D had an even more significant advantage od). No statistically significant intergroup differences were not-
over the other groups. ed. All the more interesting was the significant advantage of
group D (interferential current stimulation) in relation to the
The analysis of percentual shortening of the path length in other groups during the trial without visual control. In group
the anterio-posterior sway of the patients’ center of pressure D, a statistically significant difference was noted in relation to
indicates that the outcome of this process was the most ben- other groups. Similar tendencies occurred in other analyses.
eficial in group D (interferential current stimulation). In the
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
Discussion Similarly, Lara-Palomo et al. [10] demonstrated in their pub-

lication that the effectiveness of interferential currents was
Chronic low back pain most frequently affects persons over higher than that of superficial massage applied to the lum-
40 years of age. This condition may also cause pain radiat- bar region of the spine. The study involved 62 persons divid-
ing along the lower limbs, muscle weakness due to compres- ed into 2 groups. Patients from the first group were subject-
sion and irritation of nerve roots, as well as limitation of spi- ed to a series of treatments using IFC, whereas patients in
nal mobility. These symptoms may appear at any stage of the the second group underwent a series of massage treatments.
disease, disturbing the function of the locomotor system. They In both groups, treatments were performed for 10 weeks (a
are also a cause of disability and related social factors, which total of 20 treatments, 2 times a week). Subjective pain as-
entails increased expenditure on, among others, diagnostics sessment was performed using the visual analogue pain scale
and treatment [5]. (VAS), while the Oswestry and the Roland-Morris question-
naires were used to evaluate the functional ability of patients.
Therefore, it is necessary to search for effective treatment After the completed therapy, it was found that in comparison
methods for back pain syndromes. One of the treatment to superficial massage, the interference current led to signifi-
methods is physical therapy, which helps to reduce the dis- cantly more improvement of disability, reduction of pain, and
ease symptoms. Thus, many researchers express a consider- increase of quality of life.
able interest in this subject. Although the available literature
contains a large number of proposals for conservative treat- Turkish researchers demonstrated that TENS and exercise in-
ment of low back pain using electrical therapy, such publica- creased quality of life and reduced pain in patients with low
tions usually concern only 1 type (or, in some cases, 2 types back pain. Dogan et al. [11] evaluated 3 types of therapy in a
in a direct comparison under 1 clinical study) of electric cur- 60-person group. In the first group patients performed aero-
rent. Such articles contain a number of limitations and weak- bic and general development exercises, the second group per-
nesses, which makes it difficult to carry out an unequivocal formed general development exercises and was treated with
clinical assessment [4]. physical therapy (conventional TENS), and in the third group
the patients performed only general development exercises.
Studies conducted by Brazilian researchers confirm the high Before the therapy and after its completion, spine mobility was
effectiveness of interference currents and transcutaneous assessed with Schober’s test, pain intensity was assessed with
electrical nerve stimulation (TENS) in low back pain therapy. the visual analogue pain scale (VAS), and the disability assess-
Facci et al. [8] compared the effects of the TENS treatment ment was performed using the Roland-Morris questionnaire.
and interferential current stimulation (IFC) treatment in pa- An assessment was also made of the general mental condi-
tients with nonspecific chronic low back pain. The study in- tion of patients, using the Beck Depression Inventory (BDI).
volved a group of 150 patients, randomly assigned to 3 com- On the basis of the obtained effects, only the second study
parison groups. The first group consisted of patients who group demonstrated a statistically significant improvement as
were treated with TENS therapy, the second group was treat- regards the measured parameters and the experienced pain.
ed with the IFC currents, and the third group was not treat-
ed with any physical stimulus. Patients in the first and second However, the literature also provides examples of cases where
group underwent treatment for 30 min during 10 consecutive electrotherapy had low effectiveness or only a short-term anal-
days. In all patients, pain level was assessed using the visual gesic effect. McLoughlin et al. [12] indicated a lack of analgesic
analogue pain scale (VAS) and the McGill pain questionnaire. effect after the application of high-voltage electrical stimulation.
Evaluation of disability was also conducted using the Roland-
Morris questionnaire. Results of the study demonstrate that Ambiguous results of a study in which TENS was used in therapy
the TENS and IFC therapy brought about significant effects as of low back pain was presented in a publication by Buchmuller
in reduction of pain intensity, improvement of disability, and et al. [13]. The study involved 236 persons suffering from low
reduction in the amount of non-steroidal anti-inflammatory back pain, from 21 treatment centers in France. The patients
drugs used, in comparison to the control group. However, no were randomly assigned to 2 groups. The first group was made
significant differences were noted between patients from the up of 117 patients who were treated with active TENS treat-
first and the second group. ments, while the second group, consisting of 119 patients, was
subjected to simulated TENS treatments. The functional state
Other Brazilian researchers evaluated the effectiveness of the of patients was assessed using the Roland-Morris question-
interferential current stimulation (IFC) therapy. Correa et al. [9] naire, and pain intensity was measured in accordance with the
conducted a randomized clinical trial involving 150 patients visual analogue pain scale (VAS). Surveys were conducted be-
with a chronic, nonspecific low back pain syndrome, which con- fore the commencement of the therapy, after 2 and 6 weeks,
firmed the beneficial therapeutic effect of the IFC. and at 3 months after completion of the study. Independently
Rajfur J. et al.:
© Med Sci Monit, 2017; 23: 85-100
CLINICAL RESEARCH
of the study report, patients kept a diary to record their as- of limitations. It would certainly be worthwhile to supplement
sessment of the intensity of pain. Analysis of the obtained re- the project in the future with other modern and objective mea-
sults demonstrated similar reactions in the group of patients surement tools, such as muscle electromyography, the Biodex
who underwent the active TENS treatments and in the place- system movement analysis, and tensiometry. Also, the study
bo group as regards the assessment of functional state and did not involve “blind trials” or placebo effect assessment. In
in relation to the VAS scale. However, the assessments of pain 1 of the comparison groups, patients underwent only the stan-
intensity recorded in patients’ diaries demonstrated a highly dard functional training and were not treated with any elec-
significant difference in favor of the active TENS treatments, trotherapeutical treatment whatsoever, which constituted a
which shows a strong placebo effect of this method. point of reference in relation to the exposed groups and which
is permitted in the methodology of medical research publica-
In the meta-analysis presented by Khadilkar et al. [14], whose tions. However, using the “simulated” treatments and the so-
aim was to determine the effectiveness of TENS in the therapy called “single-blind trial” would certainly constitute an inter-
of chronic pain of the lumbar section of the spine, a series of esting addition and would also significantly raise the profile
equivocal data was recorded, confirming the use of the TENS of this study. A weakness of this research was also the rel-
as an analgesic. The authors, while performing an in-depth as- atively high measurement error (although in most cases the
sessment, noted inter alia the non-uniform methodology, the researchers do not even perform this kind of analysis or self-
discrepancies in inclusion and exclusion criteria, and the differ- reflection) during the observation of mobility of the hip joint
ing therapy durations. These differences could have contribut- and the lumbar region of the spine. We endeavored to miti-
ed to the inconsistent results. It would be valuable to have re- gate it by making our own error estimations and by making
sults from a large, multi-center research project using control sure that all measurements were made by the same person
groups (quasi-electrotherapy) and thorough randomization, as (an average of the 5 performed trials). The above deficiencies
well as to unify the methodology of the performed treatments. certainly impose certain limitations on our research. In future,
Particular attention should be given to the long-term benefits it will also be necessary to perform an assessment of remote
which may possibly be observed after the application of TENS. results, which will allow us to estimate the sustainability of
remission achieved due to electrical therapy.
Strength/weakness of the study
The novelty of our study consists in an unambiguous assess- Conclusions

ment of popular methods of electrical therapy used in low back
pain treatment under a single, prospective, randomized clini- Our conducted research indicates that using electrostimulation
cal pilot trial, based on strict inclusion and exclusion criteria, with interferential current stimulation penetrating deeper into
using both modern objective measurements and subjective the tissues results in a significant and long-term elimination of
measurements, with a uniform statistical analysis and a com- pain, and an improvement of functional ability of patients suf-
prehensive and multi-faceted observation of the achieved re- fering from low back pain on the basis of an analysis of both
sults. To the best of our knowledge, the present study is the subjective and objective parameters. Although TENS currents
first wide-ranging scientific study of low back pain electrother- and HVES are helpful in treatment of discopathy of the lower
apy in accordance with the guidelines of the “Evidence-Based region of the spine, use of interference currents led to greater
Physiotherapy”. None of the current publications made such a remission of symptoms. On the other hand, the research indi-
detailed diagnostics or a classification based on the radiolog- cates that the use of diadynamic currents appears to be use-
ical Modic assessment criteria. This allowed for a very repre- less in the course of degenerative proliferative disease of the
sentative population, which was recruited for the purpose of spine (within the scope studied in this paper).
this project. In addition, other researchers did not use calibra-
tion of the electrostimulator before each treatment. Conflict of interests
Irrespective of the innovative character of our pilot research The authors declare that there is no conflict of interests re-
and the elements of novelty, this work also contains a number garding the publication of this paper.
References:
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Efficacy of Selected Electrical Therapies On Chronic Low Back Pain: A Comparative Clinical Pilot Study

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CLINICAL RESEARCH

Corresponding Author: Jakub Taradaj, e-mail: [email protected]

Full-text PDF: http://www.medscimonit.com/abstract/index/idArt/899461

5225 11 10 14

Background of 13 December 2012). The study included patients with low

A total of 127 patients were qualified for the therapy (ulti-

Assessed for eligibility (n=238)

Allocated to Allocated to Allocated to Allocated to Allocated to Allocated to

Figure 1. Flow diagram of the study.

Table 1. Characteristic of study population in each group.

Group A Group B Group C Group D Group E Group F p – value

Body mass (kg)

Disease duration (years)

Radiological changes in Modic

Pain intensity in VAS (score)

Pain intensity in Laitinen (score)

Disability level in Oswestry (score)

Disability level in Roland-Morris

Body posture in coronal plane (mm)

Body postuare in sagittal plane (mm)

SD – standard deviation; min÷maks – minimal ÷ maximal values.

until pain occurs. The mobility range is measured in angle de-

The Schober test was used for evaluation of mobility of the

The mobility range measurements were carried out by the same

The absolute measurement error (DX) was calculated using

DX=X–X0, where X – value measured at the subsequent trial,

dX=DX/X0, where DX – absolute error, X – value measured at

Before treatment After treatment p-value

VAS – visual-analogue scale; SD – standard deviation.

Before treatment After treatment p-value

VAS scoring [%] Latinen scoring [%]

Before treatment After treatment p-value

Mean 35.11 22.05

Mean 34.95 21.87

Mean 33.04 19.95

Mean 32.88 12.05

Mean 34.33 26.05

Mean 34.30 26.01

Before treatment After treatment p-value

Mean 14.05 4.88

Mean 13.97 3.69

Mean 13.83 4.64

Mean 13.71 2.03

Mean 13.86 5.88

Mean 13.83 5.80

Oswestry scoring [%] Roland-Morris scoring [%]

Before treatment After treatment p-value

Mean 56.70 69.10

Mean 56.55 68.95

Mean 58.80 71.70

Mean 58.65 80.50

Mean 59.80 65.55

Mean 59.70 64.50

Before treatment After treatment p-value

Mean 3.25 4.50

Mean 3.20 4.45

Mean 3.30 4.60