Accepted Manuscript

“Effectiveness of Continuous Vertebral Resonant Oscillation using the POLD Methodin the treatment of lumbar disc hernia”. A randomized controlled pilot study

Juan Vicente López-Díaz , Physical Therapist, José Luis Arias Buría , PhysicalTherapist, Estrella Lopez-Gordo , BSc in Biotechnology, M.Sc. in BiomedicalResearch, Sandra Lopez Gordo , Medical resident in General Surgery, Alejandra P.Aros Oyarzún , 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: López-Díaz JV, Arias Buría JL, Lopez-Gordo E, Gordo SL, Aros Oyarzún AP,“Effectiveness of Continuous Vertebral Resonant Oscillation using the POLD Method in the treatmentof 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

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

bInternational University of Catalunya, Barcelona, Spain

cOmphis Foundation, Barcelona, Spain

dGregorio Marañón General University Hospital, Madrid, Spain

eComplutense University of Madrid, Spain

fBSc in Biotechnology, M.Sc. in Biomedical Research

gMedical 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: juanlopez@pold.es (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<0.05), and also when compared to usual treatment

(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

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

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

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

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

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

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

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.,

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

achieved and in 23% sciatica reappears, thus conservative treatment seems to be a good

choice to avoid surgery (Lurie et al., 2014).

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).

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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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

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

computer processing.

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

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

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

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

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

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

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

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

(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<0.001)

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

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

4. Discussion

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

better than of the conservative non-interventionist physiotherapy treatments

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 session’s 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

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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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

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.

6. Disclosure statement

There are no competing financial interests.

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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<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.

INITIAL ASSESSMENT FINAL ASSESSMENT DIFFERENCES BETWEEN

GROUPS

Control

(mean ± SD)

POLD

(mean ± SD)

Control

(mean ± SD)

POLD

(mean ± SD)

Differences at

completion of trial

(95% CI)

P value

Extension of the pain 4.47 ± 0.64 4.07 ± 0.70 4.47 ± 0.52 1.53 ± 1.60* 2.93 (2.04-3.82) < 0,001

Lumbar VAS 5.33 ± 2.22 5.09 ± 3.21 4.47 ± 1.79 0.79 ± 1.60 * 3.67 (2.40-4.94) 0,004

Gluteus VAS 6.07 ± 1.38 5.07 ± 2.44 4.33 ± 1.56 0.97 ± 2.22 * 3.35 (1.92-4.79) 0,028

Thigh VAS 5.10 ± 1.15 4.43 ± 2.87 3.60 ± 1.29 0.49 ± 1.19 * 3.11 (2.19-4.04) 0,010

Leg VAS 4.50 ± 2.31 3.23 ± 3 2.99 ± 1.45 0.41 ± 1.18 2.573 (1.588-3,559) 0,139

Foot VAS 1.95 ± 2.23 0.64 ± 1.15 1.007 ± 1.5069 0.280 ± 1.0844 0.727 (-0.255-1,709) 0,451

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

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 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.

0.0

0.5

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2.0

2.5

3.0

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**

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HIGHLIGHTS

• 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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ACCEPTED MANUSCRIPTAcknowledgments 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.