Accepted Manuscript

Effectiveness of Continuous Vertebral Resonant Oscillation using the POLD Method

in the treatment of lumbar disc hernia. A randomized controlled pilot study
Juan Vicente Lpez-Daz , Physical Therapist, Jos Luis Arias Bura , Physical
Therapist, Estrella Lopez-Gordo , BSc in Biotechnology, M.Sc. in Biomedical
Research, Sandra Lopez Gordo , Medical resident in General Surgery, Alejandra P.
Aros Oyarzn , Physical Therapist
PII:

S1356-689X(14)00234-3

DOI:

10.1016/j.math.2014.11.013

Reference:

YMATH 1656

To appear in:

Manual Therapy

Received Date: 23 April 2014

Revised Date:

6 November 2014

Accepted Date: 11 November 2014

Please cite this article as: Lpez-Daz JV, Arias Bura JL, Lopez-Gordo E, Gordo SL, Aros Oyarzn AP,
Effectiveness of Continuous Vertebral Resonant Oscillation using the POLD Method in the treatment
of lumbar disc hernia. A randomized controlled pilot study, Manual Therapy (2014), doi: 10.1016/
j.math.2014.11.013.
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Effectiveness of Continuous Vertebral Resonant Oscillation using the

POLD Method in the treatment of lumbar disc hernia. A randomized

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controlled pilot study.

Juan Vicente Lpez-Daza,b,c,*, Jos Luis Arias Buraa,d,e, Estrella Lopez-

International University of Catalunya, Barcelona, Spain

c

Omphis Foundation, Barcelona, Spain

Gregorio Maran General University Hospital, Madrid, Spain

e

Complutense University of Madrid, Spain

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Physical Therapist

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Gordoc,f, Sandra Lopez Gordoc,g, Alejandra P. Aros Oyarzna,b,c

BSc in Biotechnology, M.Sc. in Biomedical Research

Medical resident in General Surgery, Bellvitge Hospital, Barcelona, Spain.

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* 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: juanlopez@pold.es (Juan Vicente Lpez Daz)

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Effectiveness of Continuous Vertebral Resonant Oscillation using the

POLD Method in the treatment of lumbar disc hernia. A randomized

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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

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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

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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

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(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<0.05), and also when compared to usual treatment

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(p<0.05) for all body regions. Moreover, we observed a reduction in pain extension
(centralization phenomena) (p<0.001) in comparison with usual treatment.
In our study the POLD Method was shown to be an effective manual therapy

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approach for reducing the severity and irradiation of the pain in LDH patients with

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sciatica, and more efficient than usual treatment.

Keywords: Lumbar disc hernia; Manual Therapy; Resonant Oscillation; POLD.

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1. Introduction
Lumbar disc hernia (LDH) is a common cause of low back pain and radicular leg
pain (Takada et al., 2001). The lumbosacral radicular syndrome (LSRS), caused by a

work absenteeism and disability (Lequin et al., 2013).

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herniated lumbar disc, is one of the most expensive disorders for society in terms of

The most appropriate treatment for LDH, whether surgical or conservative, remains

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controversial due to the disparity of results in the short, medium and long term
(Weinstein et al., 2006). A very recent study claimed that patients who undergo surgery

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get better clinical results than those treated conservatively (Lurie et al., 2014), but data
from other authors suggests that the results of undergoing surgery compared to
conservative treatment are similar in the long term, with a slight advantage for surgical
treatment in the short term (Weinstein et al., 2006; Peul et al., 2007; Lequin MB et al.,

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2013). Also, surgery presents complications, surgical failure and reoperation occur
between 4% and 15% of cases (Weinstein et al., 2006; Lurie et al., 2014). Regardless of
whether the treatment is surgical or conservative, in 8% of cases no positive results are

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achieved and in 23% sciatica reappears, thus conservative treatment seems to be a good
choice to avoid surgery (Lurie et al., 2014).

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The review of these studies confirmed that no active manual therapies were used in
the conservative treatment, and the results may be different if more active and
interventionist manual therapies ("hands on") were used (Jull, 2012).
Current studies suggest that conservative treatments that have proven effective are:
stabilization exercises (Hahne, 2010) and physical therapy consisting of mild stretching
and pain relief modalities such as ultrasound, whirlpool, ice and heat pack therapy,
electrical stimulation, and/or massage (Schoenfeld, 2010). In these trials the

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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).

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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) (Lpez Daz, 2012; Lpez Daz, 2005). This

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method is an evolution of rhythmic oscillating mobilization (Maitland, 2007) with the

following differential aspects: (1) the oscillatory movement has a sinusoidal

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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.

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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

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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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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test, an alpha level of 0.05, and a desired power of 80%. These assumptions generated a

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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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selection criteria were enrolled in the trial and, after group adjudication they were
referred to one of the two reference clinics (located in different towns). A basal
evaluation of the variables required for the trial was made before beginning of

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treatment. Patients underwent 9 sessions of treatment by a blinded investigator and

assessments were performed before and after each session by a different blinded
investigator. The numerical data were forwarded to a blinded statistical analyst for

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computer processing.

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2.5. Treatment protocols

In group A (control), two blinded physiotherapists, each with over 4 years of

experience, applied identical conventional treatment to all the group A subjects without
knowing whether they were control or experimental. The protocol for the control group

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was designed after comparing 5 representative physiotherapy centres and current

evidence (Schoenfeld et al., 2010) on the protocol for usual conservative treatment of
LDH with local and radicular pain: microwave thermotherapy of the lower back (15

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minutes), analgesic electrotherapy of the lower back (transcutaneous electrical nerve

stimulation - TENS 15 minutes), ultrasound applied to the painful area (continuous: 1.5

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w/cm2 10 minutes) and self-directed muscle stretching exercises during the session
(column and legs posterior chain, psoas and quadratus lumborum).
Group B (intervention) underwent POLD treatment by another two blinded
physiotherapists, each with over 4 years of experience, who had 2 additional years of
experience in POLD Method. The protocol was identical for all of group B subjects and
consisted of a series of manoeuvres in the prone position: rhythmic oscillation of the
spine, transverse rhythmic mobilization of the lumbar and paravertebral muscles,

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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

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affected level (Figure 1).

2.6. Instrumentation

The dependent variables were analysed by a blinded physiotherapist not involved in

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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

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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

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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

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measurement of extension was discarded from the study since the movement itself,
performed in standing position, could aggravate the radicular symptoms, interfering this

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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

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physiotherapist in all sessions.

2.8. Statistical analysis

Quantitative data are shown as mean standard deviation (SD). Qualitative data are

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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

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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

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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

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considered statistically significant.

Statistical analysis of the data obtained was carried out by a blind analyst (triple-

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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 5710 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

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comparable. Baseline data for each group is detailed in Table 1.

3.1. Lumbar range of motion

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At the beginning of the trial there was no statistically significant forward flexion
range of motion differences between patients. However, on completion of treatments,

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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

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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<0,05) (data not shown). Also,

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the type of therapy applied showed differences in right side-bending values, being the
POLD method better than the control therapy (p=0.043) (Table 2). However, since the

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confidence interval crosses zero (-2.84-6.44), this data was not considered statistically
significant.

There were no significant differences between both groups for left side-bending
assessment (p=0.419) (Table 2). However, it is important to point out that there was a
trend in favour to the POLD group in all sessions even after the first one.

3.2. Severity of pain

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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

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(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

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The analysis of the pain irradiation progress shows a highly significant (p<0.001)

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reduction of the irradiation (centralization phenomena) (Werneke, 2010) in the POLD

group compared to the control group at the completion of the trial (Table 3).
Interestingly, after the first session the patients under the POLD treatment experienced a

4. Discussion

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significant reduction in the extension of pain (p<0,001) (Figure 4).

The data from this study confirm the hypothesis that the clinical results obtained with
the application of the POLD Method of manual therapy for the treatment of LDH are

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better than of the conservative non-interventionist physiotherapy treatments

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recommended by current evidence (Schoenfeld et al., 2010). This was verified by

establishing the following study objectives: range of motion and also severity and
irradiation of pain to the lower limb.
The study of range of motion showed that POLD treatment improved lumbar forward
flexion compared to the control group, without statistically significant differences for
left and right side-bending.
The study of pain severity showed important differences for the application of one or
the other treatment at completion of the trial and also as the sessions course progressed.

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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

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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).

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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

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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

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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-

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term after cessation of treatment, further studies with larger patient samples would be

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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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evidence. Our findings suggest that clinicians should consider the POLD Method for the
treatment of acute LDH in their clinical decision-making. Future studies would be
necessary to investigate the medium and long-term effects of POLD treatment in

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patients with acute LDH, as well as using larger patient samples to increase the power
of the study and, this way, overcome the limitations of this pilot study.

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There are no competing financial interests.

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6. Disclosure statement

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TABLES
Table 1. Demographic features of both groups at the beginning of the study.
CONTROL

(N=15)

(N=15)

58.10 15.18

57.30 10.18

No. of male patients (%)

4 (26.7)

No. of female patients (%)

11 (73.3)

7 (46.7)
8 (53.3)

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Location of the hernia in n patients (%)

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Age in years (mean SD)

POLD

0 (0)

1 (6.7)

L4

5 (33.3)

5 (33.3)

L5

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L3

10 (66.7)

9 (60)

12 (80)

10 (66.7)

3 (20)

5 (33.3)

Side of the radiculopathy in n patients (%)

R
L

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Extension of the pain (mean SD)

Lumbar VAS (mean SD)

4.07

0.70

5.09 3.21

4.47

0.64

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

4.50

2.31

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

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Leg VAS (mean SD)

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Foot VAS (mean SD)

3.23

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.
DIFFERENCES
INITIAL ASSESSMENT

FINAL ASSESSMENT
BETWEEN GROUPS
Differences at

Control

POLD

Control

POLD

(mean in cm SD) (mean in cm SD) (mean in cm SD) (mean in cm SD)

completion of

P value

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trial (95% CI)

Forward flexion

25.27

12.28

19.73

12.54

26.87

9.39

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)

11.73 (3.46-20)

0,007

0,419

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15.13 12.49 *

R: right; L: left. ANOVA for repeated measurements with the Bonferroni correction was applied with a

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confidence interval (CI) of 95% for the difference in means. Differences were considered statistically
significant (*) for p<0.05 compared to the control group. (**) Not significant because CI crosses zero.

Table 3. Results of the analysis between groups for the assessment of pain.

Lumbar VAS

Control

POLD

(mean SD)

(mean SD)

(mean SD)

(mean SD)

0.64 4.07 0.70

completion of trial

P value

(95% CI)

4.47

0.52

1.53

1.60*

2.93 (2.04-3.82)

< 0,001

5.33

2.22 5.09 3.21

4.47

1.79

0.79

1.60 *

3.67 (2.40-4.94)

0,004

6.07

1.38 5.07 2.44

4.33

1.56

0.97

2.22 *

3.35 (1.92-4.79)

0,028

3.60

1.29

0.49

1.19 *

3.11 (2.19-4.04)

0,010

2.99

1.45

1.18

2.573 (1.588-3,559)

0,139

0.727 (-0.255-1,709)

0,451

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Gluteus VAS

POLD

4.47

GROUPS
Differences at

Control

EP

Extension of the pain

DIFFERENCES BETWEEN

FINAL ASSESSMENT

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INITIAL ASSESSMENT

Thigh VAS

5.10

1.15

4.43 2.87

Leg VAS

4.50

2.31

Foot VAS

1.95

2.23 0.64 1.15

3.23

1.007

0.41

1.5069 0.280 1.0844

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<0.05 compared to the control group. The extension of the pain was calculated as described in
materials and methods with values between 0 and 5.

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FIGURES

Figure 1. POLD Method application to generate a rhythmic oscillation in the spine: arrows indicate the

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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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5.0

4.0

Control
Pold

3.5

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* *

3.0

2.5

2.0
1.5

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Extension of the pain

4.5

0.5
0.0
0

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1.0

No. of Sessions

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Figure 4. Extension of the irradiation of the pain. The values are expressed following the body chart
described in materials and methods and represented as mean standard error. Differences were
considered statistically significant (*) for p<0.001 compared to the initial values.

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HIGHLIGHTS

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The POLD Concept is a novel method based on the continuous resonant

oscillation.
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 Collegi 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

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and, in particular, Dr. Rafael Torrubia-Beltri for his guidance and supervision of the

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whole scientific study process.