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8/9/2019 2014 Effectiveness of Continuous Vertebral Resonant Oscillation Using the POLD Method in the Treatment of Lumbar Disc Hernia. a Randomized Controlled …
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“Effectiveness of Continuous Vertebral Resonant Oscillation using the
POLD Method in the treatment of lumbar disc hernia”. A randomized
controlled pilot study.
Juan Vicente López-Díaza,b,c,*
, José Luis Arias Buríaa,d,e
, Estrella Lopez-
Gordoc,f
, Sandra Lopez Gordoc,g
, Alejandra P. Aros Oyarzúna,b,c
aPhysical Therapist
b International University of Catalunya, Barcelona, Spain
cOmphis Foundation, Barcelona, Spain
d Gregorio Marañón General University Hospital, Madrid, Spain
eComplutense University of Madrid, Spain
f BSc in Biotechnology, M.Sc. in Biomedical Research
g Medical resident in General Surgery, Bellvitge Hospital, Barcelona, Spain.
* Corresponding author. Research department of the
Omphis Foundation, Plaza Enric Granados 9-1-1,
08290 Cerdanyola, Barcelona, Spain. Tel.: +34 609 724 888, fax: +34 93 667 20 35.
E-mail address: [email protected] (Juan Vicente López Díaz)
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“Effectiveness of Continuous Vertebral Resonant Oscillation using the
POLD Method in the treatment of lumbar disc hernia”. A randomized
controlled pilot study.
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Abstract
This study analyses the efficacy of manual oscillatory therapy, following the POLD
technique, for acute Lumbar Disc Hernia (LDH) and compares it to usual treatment. A
randomised, controlled, triple-blind pilot clinical trial. The sample of 30 patients was
divided into two homogeneous groups to receive usual treatment (A) or treatment with
the POLD technique (B). We analysed range of motion and subjective variables such as
the severity (visual analogue pain scale (VAS)) and extension of the pain. With the
application of POLD therapy, patients presented significant changes on range of motion
(forward flexion with p < 0.05) at completion of the trial in comparison with the control
group. They showed a significant reduction in the severity of pain with a mean VAS
scale for lumbar, gluteus and thigh pain, which improved from 5.09 to 0.79, 5.07 to 0.97
and 4.43 to 0.49 respectively (p
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intervention with manual therapy is under-represented. Also, current studies show that
the use of manual therapy (“hands on”) in combination with epidural steroid injections
is highly beneficial to prevent surgery for lumbar disc herniation (Van HH., 2014).
In the current work we study a novel conservative treatment performed primarily
with active specialized manual therapy (“hands on”) named the POLD Concept
(Pulsation Oscillation Long Duration) (López Díaz, 2012; López Díaz, 2005). This
method is an evolution of rhythmic oscillating mobilization (Maitland, 2007) with the
following differential aspects: (1) the oscillatory movement has a “sinusoidal”
waveform, (2) resonant oscillation frequency is used between 1.2-2 Hz., (3) oscillation
is maintained throughout treatment and is called primary oscillation, (4) very small
amplitude (less than grade 1 according to Maitland) within the “neutral zone” (Panjabi,
1992) are used.
To date, the neurophysiological bases explaining the POLD Method effects are not
yet known. However, previous studies on the effects of vertebral oscillations in different
areas can assist in understanding the results of this study: Oscillating mobilizations are a
positive aid in the reduction of inflammatory joint pain (Dhondt, 1999). Studies in
workers who spend a lot of time in a sitting position have shown that low-frequency
oscillations applied to the seat have a positive effect on the reduction of back pain (Van
Deursen et al., 1999) and that rotational oscillations of the vertebrae reduce intradiscal
pressure and increase disc height (Van Deursen et al., 2000; Van Deursen and Snijders,
2001).
The working hypothesize of this study is that POLD Method may be more effective
than the standard treatments of physiotherapy, which are the ones usually compared to
the surgical option.
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2. Materials and methods
2.1. Subjects
The recruitment period was between April and July 2010. Thirty patients (11 men
and 19 women), between 31 and 63 years of age (mean 57.7; SD 12.6 years), with
homogeneous initial clinical characteristics. Inclusion criteria: (1) back pain, (2)
radicular pain and neurologic deficit in radicular distribution to only one lower limb
such as paresthesias, weakness and decreased reflexes, (3) limitation of lumbar range of
motion greater than 20% of the usual values in healthy people (Kelley 1983), (4)
diagnosis of LDH with previous MRI (less than 4 months previous to the start of the
randomized pilot clinical trial) confirming the relationship between the level of the
hernia and the radicular pain of the patient, (5) no surgical treatment, and (6) acute
injury stage of the current episode (duration of the episode of less than 4 months) with
no previous episodes within 1 year. Exclusion criteria: (1) have been treated with
corticosteroid infiltrations, (2) be under any other type of physiotherapy treatment, (3)
suffer any other type of pathologies that could mask the symptoms or produce similar
ones, (4) present a “red flag” (osteoporosis, infection, tumours, etc.) and (5) presence of
characteristics in the subjects, detected during the anamnesis, that could interfere with
the study, such as simulators (patient that always expresses pain just to be off work).
All the subjects received an information sheet and signed an informed consent form.
The trial was supervised and received the ethical approval by the Department of Cell
Biology, Physiology and Immunology of the Institute of Neuroscience at the
Autonomous University of Barcelona, as part of the Neuroscience doctorate study
program.
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2.2. Allocation
Following the baseline examination, patients were triple-blind randomly assigned to
receive the control or POLD treatment. Concealed allocation to the group was made by
a randomisation programme (Epidat 3.1) created prior to the beginning of the study.
Individual, sequentially numbered index cards with the random assignment were
prepared. The index cards were folded and placed in sealed opaque envelopes and were
kept hidden by an investigator not participating in any other phase of the trial. Each
patient enrolled in the trial was sent to one clinic to receive the usual treatment or to
another clinic for POLD treatment according to the content of the envelope; the
assignation was unknown by the patient as well as the therapist providing the treatment.
2.3. Sample size determination
The sample size and power calculations were performed using the software
GRANMO7.11. Calculations were based on detecting differences of 2 units in a 10
numerical pain rate scale at post-data, assuming a standard deviation of 1.9, a 2-tailed
test, an alpha level of 0.05, and a desired power of 80%. These assumptions generated a
sample size of 30 subjects, 15 per group.
2.4.
Study protocol.
Subjects who participated in this study were either self-referred or referred by a
physician team. All subjects were asked to provide documented diagnostic results about
their pathology (Rx, MRI, CAT, EMG, etc.) and, if these were not available, they were
scheduled for the performance of the medical diagnostic and instrumental diagnostic
tests to aid in assessing whether they were candidates for the trial. Subjects meeting the
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oscillatory spinal decompression from the sacrum, lateral opening of the affected level
by oscillatory inclination and symmetric oscillatory rotation at the vertebrae of the
affected level (Figure 1).
2.6. Instrumentation
The dependent variables were analysed by a blinded physiotherapist not involved in
any other aspect of the trial. The main variable was the measurement of the severity of
the pain using a visual analogue pain scale (VAS) (Huskisson, 1974), completed by
each patient at each session and for each area independently (lower back, gluteus, thigh,
leg and foot). The secondary variables were: (1) objective lumbar range of motion with
fingertip-to-floor test (Perret, 2001) (measurement in centimetres of the distance from
the floor to the 3rd finger during active movements of forward flexion and right and left
side-bending with the patient standing) and (2) pain extension, recorded on a body chart
without references where the patient marked the area of their pain which was later
coded to analogue values from 0 to 5 for statistical processing (Figure 2). The
measurement of extension was discarded from the study since the movement itself,
performed in standing position, could aggravate the radicular symptoms, interfering this
way with other dependent variables. No rotation measurements were conducted.
2.7. General conditions common to the treatments applied
The treatment protocol was applied under the same conditions in both groups to
prevent contamination of the trial. A total of 9 sessions (3 sessions/week, 3 weeks in
total from the beginning to the end of the study) with the treatment in each session
lasting between 45-60 minutes were performed. A total of four physiotherapists
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provided the treatment and each of them handled 7-9 patients to enable coordination of
schedules and patient availability. Each patient was always treated by the same
physiotherapist in all sessions.
2.8. Statistical analysis
Quantitative data are shown as mean ± standard deviation (SD). Qualitative data are
expressed as frequencies and percentages. The study of the normality of quantitative
variables was done applying the Kolmogorov-Smirnov test. Fisher's exact test was used
for qualitative variables and Student's T-test for independent groups for numerical
variables.
Analysis of variance for repeated measurements (ANOVA) with the Bonferroni
correction was used to study the progress of the different variables over time and
between both groups. The main result was considered to be the difference between the
first and the ninth treatment session for each group. All statistical analyses were
performed using the program SPSS® version 21. Results with p value (p)< 0.05 were
considered statistically significant.
Statistical analysis of the data obtained was carried out by a blind analyst (triple-
blind) who was provided the data without associating it with any variable to ensure
independence of the processing.
3.
Results
The total number of subjects screened, the reasons for ineligibility and drop out can
be seen in Figure 3. Fifteen patients (4 men and 11 women) aged 37 to 63 (mean age
58 ±15 years) were assigned to the experimental group, and 15 patients (7 men and
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8 women) aged 31 to 61 (mean 57±10 years) formed the control group. All patients
completed the treatment and no significant differences were found between groups
for any of the measured parameters at the start of the study, thus both groups being
comparable. Baseline data for each group is detailed in Table 1.
3.1. Lumbar range of motion
At the beginning of the trial there was no statistically significant forward flexion
range of motion differences between patients. However, on completion of treatments,
the progress between groups differed, presenting a significant increase in range of
motion for the group under POLD treatment (p=0.007) (Table 2). Interestingly, a
significant effect in the POLD group was observed at an early point, after the third
session with a p=0.020 (data not shown). Despite these results, the confidence interval
is very large (3.46 to 20), indicating a high variability in the data (Table 2).
Right side-bending showed a positive evolution with the number of sessions
reporting significant differences since the sixth session (p
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The analysis of the severity of pain shows significant differences with reduction of
the pain in patients under POLD treatment compared to the control group, with an
improvement of the lumbar VAS (p=0.004), gluteus VAS (p=0.028), and thigh VAS
(p=0.010) at the completion of the trial, whereas there were no significant differences in
the Leg and Foot VAS (Table 3).
3.3. Pain extension
The analysis of the pain irradiation progress shows a highly significant (p
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The POLD group showed a more rapid reduction of pain severity and also of pain
extension along the lower limb, implying that this treatment shows greater benefits in
fewer sessions compared to the conventional treatment. The centralization of the pain is
the most important effect observed in the study as it shows a direct effect on a favorable
prognosis, as it has been previously stated (Aina, 2004), and also shows a direct effect
on the lumbar intervertebral disc (Laslett, 2005).
These aspects should be taken into account when choosing which type of
physiotherapy treatment should be applied for LDH. This pathology is very painful and
incapacitating, thus it is useful to know that the POLD Method of manual therapy is an
option as treatment for LDH as it achieves a faster and greater improvement than the
conventional treatment used in this study. However, despite the benefits that this novel
treatment offers, it is necessary to perform further studies to determine whether similar
results are found when comparing POLD treatment to other interventionist
physiotherapy approaches. Moreover, although preliminary results with no statistical
value show that the beneficial effects of POLD treatment are maintained in the medium-
term after cessation of treatment, further studies with larger patient samples would be
necessary to investigate long-term effects of POLD treatment in patients with LDH.
5.
Conclusion
In view of the results obtained in this trial we conclude that for LDH pathology it is
evident that treatment with POLD technique, characterized by a maintained resonant
oscillatory mobilization (“hands on”), is more effective in increasing range of lumbar
flexion, reducing the subjective severity of pain and causing a rapid centralization when
compared with standard physiotherapy treatment (“hands off”) recommended by current
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TABLES
Table 1. Demographic features of both groups at the beginning of the study.
POLD
(N=15)
CONTROL
(N=15)
Age in years (mean ± SD) 58.10 ± 15.18 57.30 ± 10.18
No. of male patients (%)
No. of female patients (%)
4 (26.7)
11 (73.3)
7 (46.7)
8 (53.3)
Location of the hernia in nº patients (%)
L3
L4
L5
0 (0)
5 (33.3)
10 (66.7)
1 (6.7)
5 (33.3)
9 (60)
Side of the radiculopathy in nº patients (%)
R
L
12 (80)
3 (20)
10 (66.7)
5 (33.3)
Extension of the pain (mean ± SD) 4.07 ± 0.70 4.47 ± 0.64
Lumbar VAS (mean ± SD) 5.09 ± 3.21 5.33 ± 2.22
Gluteus VAS (mean ± SD) 5.07 ± 2.44 6.07 ± 1.38
Thigh VAS (mean ± SD) 4.43 ± 2.87 5.10 ± 1.15
Leg VAS (mean ± SD) 3.23 ± 3 4.50 ± 2.31
Foot VAS (mean ± SD) 0.64 ± 1.15 1.95 ± 2.23
Forward flexion (mean in cm ± SD) 19.73 ± 12.54 25.27 ± 12.28
Side-bending R (mean in cm ± SD) 45.47 ± 4.34 44.20 ± 6.77
Side-bending L (mean in cm ± SD) 49.07 ± 4.53 44.80 ± 7.04
R: right; L: left; SD: standard deviation; %: percentage of cases; VAS: visual analogue pain scale.
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Table 2. Results of the analysis between groups for range of motion.
INITIAL ASSESSMENT FINAL ASSESSMENT
DIFFERENCES
BETWEEN GROUPS
Control
(mean in cm ± SD)
POLD
(mean in cm ± SD)
Control
(mean in cm ± SD)
POLD
(mean in cm ± SD)
Differences at
completion of
trial (95% CI)
P value
Forward flexion 25.27 ± 12.28 19.73 ± 12.54 26.87 ± 9.39 15.13 ± 12.49 * 11.73 (3.46-20) 0,007
Side-bending R 44.20 ± 6.77 45.47 ± 4.34 44.60 ± 5.51 42.80 ± 6.82 1.80 (-2.84-6.44) 0,043 * *
Side-bending L 44.80 ± 7.04 49.07 ± 4.53 45.47 ± 7.55 43.27 ± 7.14 2.20 (-3.29-7.69) 0,419
R: right; L: left. ANOVA for repeated measurements with the Bonferroni correction was applied with a
confidence interval (CI) of 95% for the difference in means. Differences were considered statistically
significant (*) for p
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FIGURES
Figure 1. POLD Method application to generate a rhythmic oscillation in the spine: arrows indicate the
produced movement in the spinal process (A) and the induced oscillatory movement in the spine (B).
Figure 2. Body chart for assessment of the extent of the pain.
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Figure 3. Flow diagram of subject recruitment throughout the course of the study.
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Figure 4. Extension of the irradiation of the pain. The values are expressed following the body chartdescribed in materials and methods and represented as mean ± standard error. Differences were
considered statistically significant (*) for p
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•
The POLD Concept is a novel method based on the continuous resonantoscillation.
• The POLD technique increases the forward flexion range of motion in Lumbar
Disc Hernia (LDH).
• The POLD technique produces a rapid centralization and pain severity reduction
in LDH.
• The POLD treatment is more effective than conventional physiotherapy for
LDH.
• The POLD treatment is a conservative therapy of choice in acute LDH.
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Acknowledgments
We would like to thank Col·legi de Fisioterapeutes de Catalunya for their financial
support for the study and Omphis Foundation for letting us use their clinical
infrastructures to conduct the treatment sessions. Also, we would like to thank the team
of teachers of the Institute of Neurosciences at the Autonomous University of Barcelona
and, in particular, Dr. Rafael Torrubia-Beltri for his guidance and supervision of the
whole scientific study process.