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Effects of Artcure Diffusional Patch application on pain and functional status

in lumbar disc herniation patients: a prospective randomized controlled study

Article in Turkish Journal of Medical Sciences · June 2017

DOI: 10.3906/sag-1603-98

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 Turkish Journal of Medical Sciences Turk J Med Sci
(2017) 47: 874-882
http://journals.tubitak.gov.tr/medical/
© TÜBİTAK
Research Article doi:10.3906/sag-1603-98

Effects of Artcure Diffusional Patch application on pain and functional status in lumbar
disc herniation patients: a prospective randomized controlled study
1 1 2 3 1
Mahmut UĞURLU , Mehmet Atıf Erol AKSEKİLİ , Berat Meryem ALKAN , Halil KARA , Ceyhun ÇAĞLAR
1
Department of Orthopedics and Traumatology, School of Medicine, Yıldırım Beyazıt University, Ankara, Turkey
2
Department of Physical Therapy and Rehabilitation, School of Medicine, Yıldırım Beyazıt University, Ankara, Turkey
3
Department of Pharmacology, School of Medicine, Yıldırım Beyazıt University, Ankara, Turkey

Received: 14.03.2016 Accepted/Published Online: 29.12.2016 Final Version: 12.06.2017

Background/aim: The aim of this study was to assess the efficacy of the Artcure Diffusional Patch, which contains a mixture of 6 herbal
oils (oleum thymi, oleum limonis, oleum nigra, oleum rosmarini, oleum chamomilla, oleum lauriexpressum) and has a hypoosmolar
lipid structure, in the conservative treatment of lumbar disc herniation patients and to show the advantages and/or possibility of using
this as an alternative method to surgery.
Materials and methods: Of the 120 patients enrolled, 79 clinically diagnosed patients were included in the study. Clinical evaluations
were performed on patients who had findings of protrusion or extrusion in their magnetic resonance results. The treatment group was
treated with the Artcure Diffusional Patch while the control group received a placebo transdermal diffusional patch. The functional state
of patients was measured using the Oswestry Disability Index and pain intensity was measured with a visual analog scale as primary
outcomes. Secondary outcomes of the study were Lasegue’s sign, the femoral stretching test, and paravertebral muscle spasm.
Results: The treatment group showed a dramatic recovery in the first month following the application in regards to Oswestry Disability
Index scores and visual analog scale values. The patients treated with the Artcure Diffusional Patch showed a statistically significant
difference in recovery as compared to the control group.
Conclusion: These findings suggest that the Artcure Diffusional Patch may be an alternative for the conservative treatment of lumbar
disc herniation with radiculopathy.

Key words: Lumbar disc herniation, Artcure Diffusional Patch, Oswestry Disability Index

1. Introduction loss occur by the loss of proteoglycan and the effects of

Among Western societies 84% of adults suffer from low back proinflammatory cytokines (6). As a result of these, clinical
pain at some time in their lives (1). Low back pain is the signs such as pressure on nerve roots and the spine occur.
most frequent reason for disability in the population below The purpose of treatment is reducing the pain and increasing
the age of 45 (2). The treatment costs for low back pain are the functional activity by removing the pressure on the
a significant part of medical costs and at about 34 billion nerve roots by either surgical or conservative methods.
dollars; by adding the economic loss due to workforce The decision between surgical and nonsurgical
loss, this number increases to 100 billion dollars in the management of LDHR can be challenging for both the
United States (3,4). Lumbar disc herniation with associated patient and the treating physician. Generally surgical
radiculopathy (LDHR) ranks first among the diseases intervention is suggested to patients with acute and
that cause low back pain. For this reason, an inexpensive, progressive neurological deficit and those who are
noninvasive, and efficient treatment method is required in nonresponsive to conservative treatments (7). In light of
order to reduce and delay surgical interventions of LDHR the costs of surgical treatments and the scale of possible
patients and minimize the workforce loss during the period complications, noninvasive treatment becomes the best
until surgical intervention. option. Since the intervertebral discs are the largest
Lumbar disc herniation is the displacement of the avascular structures of the body, nourishment is supplied by
nucleus pulposus by the breaching of the annulus fibrosus diffusion. Because of this avascularity, there is no possibility
(5). With increasing age disc degeneration and disc height for spontaneous recovery (8).
* Correspondence: [email protected]
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The Artcure Diffusional Patch (ADP) contains a Index (ODI) was used in order to evaluate the functional
mixture of 6 herbal oils (oleum thymi, oleum limonis, state, patient satisfaction, return to military duty, and need
oleum nigra, oleum rosmarini, oleum chamomilla, oleum for additional surgery. Lasegue’s sign and femoral stretch
lauriexpressum) and has a hypoosmolar lipid structure. test results were also recorded. Magnetic resonance imaging
These hypoosmolar fatty acids have been used in therapy was evaluated by two experienced neuroradiologists
before, but this is the first time that they are being used in and a radiological diagnosis was made. Each patient was
combination for the treatment of lumbar disc herniation. examined by the same physician throughout the trial. The
These fatty acids are not dosed sufficiently for therapeutic physicians and nurses involved in these assessments were
use. These oil ingredients of ADP increase the membrane unaware of the treatment received.
permeability of the herniated nucleus pulposus, decrease Secondary outcomes were measured by physical
the intraosmotic pressure, and cause water loss by examination (disability of movement, test of Lasegue’s
diffusion. By these antiinflammatory and antiedema sign, femoral stretching test, paravertebral muscle
effects, the mass decreases. By using dextrin palmitate, the spasm). The VAS, ODI, and physical examinations were
hypoosmolar fatty acids were formulated as a gel. As the administered before the application of the patches, on the
dissolvent of dextrin palmitate, liquid paraffin was used. third day after application, and the first month thereafter.
The purpose of this study was to assess the efficacy of the If a patient’s functional state recovery, pain reduction, and
ADP in the conservative treatment of patients with lumbar negative score in the Lasegue test were more than 50%, the
disc herniation and to show the advantages of/possibility recovery was accepted as significant (9,10).
of using it as an alternative method of nonsurgical Demographic information, medical history, and
intervention to surgery. physical examination findings of patients were recorded
and served as the baseline.
2. Materials and methods Randomization took place after we had obtained
The study was conducted prospectively in 2014 and written informed consent from the study participants and
gathered baseline information. The assignment scheme
2015 as a randomized placebo controlled trial with
was generated from the patient’s hospital files. The patients
patients admitted to the orthopedics, traumatology, and
were divided into two groups by using the last numbers
physiotherapy clinics at the Yıldırım Beyazıt University
of the patient’s hospital files: odd numbers were included
Atatürk Training and Research Hospital, Ankara,
in the ADP group (treatment group) and patients with
Turkey. The study was performed under the terms of the
even numbers were included in the control transdermal
Declaration of Helsinki and the protocol was approved by
diffusional patch (TDP) group (control group).
the ethics committee of the institution (approval date and
The patches used as TDPs and applied to the patients in
number: 03.09.2014–26379996/151).
the control group were similar to the ADP in appearance
Patients were eligible if they were in the age range of
and size. The same inactive ingredients in the gel structure
20–60 years, had been referred for pain in one or two lower of the ADP (dextrin palmitate derivative and liquid
extremities that caused functional disability, had findings in paraffin) were used in TDPs but as for liquid components
magnetic resonance results such as protrusion or extrusion, to change the osmotic gradient, glycerin was used instead
had radiological findings that conformed with discogenic and evenly (11).
sciatica that followed a dermatomal distribution, and had Ninety-seven patients (48 males, 49 females) with a
low back pain refractory to physiotherapy and NSAIDs. mean age of 43.1 years (range: 18–60 years) were admitted
Sciatica was defined as the presence of constant or to the study. The average duration of complaints of low
intermittent pain in one or both legs, radiating below the back pain was 2 years (range: 0.5–20 years) and 50.6% of
knee. Signs of nerve root irritation (a positive straight-leg patients had right while 49.4% of patients had left radicular
test, defined as reproduction of radicular pain by elevation pain. There was no statistically significant difference
of the leg ) or nerve root compression (motor, sensory, or between the two groups regarding the demographic data
reflex deficits), or both, had to be present with computed of the level of hernia and anatomical type of herniation.
tomographic evidence of a herniated nucleus pulposus at a The patients in the ADP group mostly had multiple levels
level corresponding to the symptoms and clinical findings. of hernia, while the patients in the TDP group mostly
Patients were excluded if they had lumbar surgery, had a single level of hernia (P = 0.001). According to the
spinal stenosis or deformity (scoliosis, spondylolysis, anatomical type of herniation, the patients in the ADP
vertebral fracture sequelae), loss of motor activity at ≥3/5 group mostly had bulging-type hernias, while the patients
in any lower extremity muscle section, uncontrolled acute in the TDP group had more protruded discs (P < 0.001)
or chronic systemic diseases, or atopic skin. (Table 1).
Outcomes were assessed using a visual analog scale The superior border of the iliac crest was palpated
(VAS) for the degree of pain, while the Oswestry Disability while the patients were lying in a prone position and the

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Table 1. Demographical data of groups. Independent t-test (bootstrap) - Mann–Whitney U test (Monte Carlo) -
Fisher exact test (exact) - Pearson chi-square test (Monte Carlo). Average data ± standard deviation; median (range);
n (%).

Control Experiment P-value

n = 46 (47.4) n = 51 (52.6)
Age 42.3 ± 9.59 43.8 ± 10.77 0.458
Sex Female 24 (52.2) 25 (49.0) 0.840
Male 22 (47.8) 26 (51.0)
BMI 26.1 ± 4.26 27.8 ± 4.09 0.053
Smoking No 29 (63.0) 33 (64.7) 1
Yes 17 (37.0) 18 (35.3)
Marital status Single 10 (21.7) 6 (11.8) 0.273
Married 36 (78.3) 45 (88.2)
Duration of low back pain (years) 2 (0.5–12) 2 (0.5–20) 0.452
Radicular pain Right 22 (47.8) 26 (51.0) 0.840
Left 24 (52.2) 25 (49.0)
Level of herniation Multiple 8 26 0.001
Single 38 25
Type of herniation (anatomically) <0.001
Protruded 34 26
Extruded 12 25
Type of herniation (location) Central 21 26 0.053
Posterolateral 25 25

L4–5 level was determined. The level of disc pathology was per category. The score for the pain-rating index, which
identified by drawing a line with a dermal pen. The center corresponds to the sum of the numerical values of the
of the patch was placed on the marked area (Figure 1). The descriptors chosen by the patient, ranges from 0 (no pain)
patients were hospitalized for 24 h and held in a supine to 77 (the most severe pain in every category).
position. They were allowed to stand up for a maximum of 3 Functional disability was assessed with the Oswestry
times each hour during 24 h. All of the patients showed full Low Back Pain Disability Questionnaire and the Sickness
compliance with the study protocols and exercise program. Impact Profile, both slightly modified by adding “and/or
None of the patients needed bracing applications. leg” to all statements that contained the word “back”. The
The patients rated the perceived degree of overall Oswestry Low Back Pain Disability Questionnaire has 10
improvement or deterioration on a descriptive seven-item sections, on walking, sleeping, and social activities . The
scale that ranged from very marked improvement to very overall score ranges from 0 to 100, with a score of 20 or
marked deterioration. The intensity of leg pain in the week less indicating minimal disability for which no treatment
preceding the visit was assessed on a VAS ranging from 0 (no is usually indicated and higher scores indicating greater
pain) to 100 (worst pain possible). The patients completed disability. The Sickness Impact Profile measures perceived
two components of the McGill Pain Questionnaire. The health status and changes in functional status due to sickness.
first component measures the present intensity of pain It consists of 136 questions grouped into 12 categories (e.g.,
on the basis of the response to one question, recorded as physical dimensions and psychosocial dimensions). Both
a number from 0 (no pain) to 5 (excruciating pain). The instruments have been shown to be reliable and sensitive
second component is a pain-rating index involving 77 to changes in patients with low back pain. The patients also
pain descriptors (e.g., lancinating, cramping, and burning) reported the number of days in the previous 2 weeks when
grouped into 20 categories. The descriptors in each they had limited their activities because of back or leg pain.
category are ranked numerically according to the severity During data analysis, SPSS 22.0 (IBM Corp., Armonk,
of pain. Patients can choose no more than one descriptor NY, USA) and PAST3 (Øyvind Hammer, Natural History

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Figure 1. ADP application.

Museum, University of Oslo, Oslo, Norway) were used, tested by Monte Carlo simulation technique. For the
and for power analysis the G Power program was used. determination of the most important risk factor among
The Shapiro–Wilk test was used for the compliance of the significant categorical risk factors the odds ratio was
normal distribution of univariate data and the Mardia used. Quantitative data were expressed as mean ± standard
(Doornik–Hansen omnibus) test was used for the deviation and median (maximum–minimum) values
compliance of normal distribution of multivariate data. and were tabulated. Categorical data were expressed as n
The Levene test was used for homogeneity of variance. (number) and percentage (%). The 95% confidence levels
The independent-samples t-test was used with bootstrap were set and P values were accepted to be significant at P
results in order to compare two independent groups < 0.05.
and the Mann–Whitney U test was used for simulation Fifteen percent of the total patients admitted to these
techniques. The general linear model-repeated ANOVA clinics complained of low back pain. Therefore, two
test was used with Cochran’s Q test in order to measure groups were formed presuming this rate as 20% in order
measurements of dependent variables repeated more to increase the power of our sample size.
than two times. Nonparametric (Miller) post hoc tests ADP, which was applied to Group 1, contains a
and least significant difference (LSD) tests were used for mixture of 6 herbal oils (oleum thymi, oleum limonis,
post hoc analysis. For comparison of categorical data oleum nigra, oleum rosmarini, oleum chamomilla, oleum
Pearson chi-square and Fisher exact tests were used and lauriexpressum) and has a hypoosmolar lipid structure.

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3. Results (P < 0.001). In the treatment group, patients who showed

A total of 120 patients were enrolled (Figure 2). Three positive simple leg raising and femoral stretching tests
patients had had lumbar surgery before and 2 patients had were 80% and 77.5%, 40% and 37.5%, and 10% and 15%
scoliosis deformation; therefore, they were excluded from before the application, on the third day, and at the end
the study. Eighteen patients declined to participate in of the first month, respectively (P < 0.001). A significant
the study for various reasons. The remaining 97 patients recovery was seen in the motion gap between lumbar and
were randomly divided into two groups. During the articular faces when comparing the findings before the
study, 11 of 51 patients who received the ADP and 7 of application, on the third day, and in the first month (P <
46 patients who received the TDP were excluded due to 0.001).
noncompliance. Consequently, 40 patients who received Regarding the patients in the TDP group, VAS values
the ADP and 39 patients who received the TDP were and ODI scores had a statistically significant minimal
evaluated. The baseline characteristics were similar in the decrease when compared with the baseline values. There
two groups (Table 1). were no statistically significant differences except for
After the patients were evaluated clinically and paravertebral muscle spasms and the femoral stretching
radiologically and all of the data were gathered at the final test (Table 4).
visit in March 2016, the study was terminated. There was a statistically significant difference between
When comparing the ODI scores, VAS values, and the two groups before the application and on the third day
physical examination findings of the treatment and control after application (Table 5).
groups, there was statistically significant difference only Comparing the clinical features of patients on the third
in paravertebral muscle spasms (P = 0.035). There were day after the application with all physical examination
no statistically significant differences between the other findings and scores, a statistically significant difference
values (Table 2). between the patients in the ADP group and the patients in
In the treatment group, a dramatic recovery was the TDP group was seen (Tables 3–5).
achieved in the first month with respect to ODI scores and Two patients from the TDP group developed bullous
VAS values (Table 3). In this group, the average VAS value lesions with serous fluid. They were treated with topical
was 9 (range: 3–10) before application and it decreased medications.
to 5 (range: 2–10) at the end of first month (P < 0.042). In conclusion, we found that application of ADP,
The average ± standard deviation ODI score was 59.2 ± as compared with the control TDP, showed better
13.37, reduced to 33.4 ± 10.13 at the end of the first month improvement in leg pain and sensory deficits.

Figure 2. Flowchart of the study and follow-up of patients.

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Table 2. Clinical features of groups before application. Independent t-test (bootstrap) - Mann–Whitney U
test (Monte Carlo) - Fisher exact test (exact). Average data ± standard deviation; median (range); n (%). ª:
Odds ratio (95% confidence interval for odds ratio); º: reference taken for odds ratio.

Control Experiment
P-value
46 (47.4) 51 (52.6)
ODI 61.8 ± 11.42 60.9 ± 13.15 0.724
VAS 8 (3–10) 10 (3–10)
SLR Positive 36 (78.3) 42 (82.4) 0.620
Negative 10 (21.7) 9 (17.6)
K-SLR Positive 32 (69.6) 36 (70.6) 1
Negative 14 (30.4) 15 (29.4)
Flexion Normal 18 (39.1) 20 (39.2) 1
Disabled 28 (60.9) 31 (60.8)
Extension Normal 19 (41.3) 19 (37.3) 0.835
Disabled 27 (58.7) 32 (62.7)
Right L flexion Normal 19 (41.3) 22 (43.1) 1
Disabled 27 (58.7) 29 (56.9)
Left L flexion Normal 19 (41.3) 22 (43.1) 1
Disabled 27 (58.7) 29 (56.9)
Paravertebral muscle spasm Yesº 36 (78.3) 48 (94.1) 0.035
No 10 (21.7) 3 (5.9) 4.4 (1.1–17.2)ª
Femoral stretching test Positive 31 (67.4) 38 (74.5) 0.504
Negative 15 (32.6) 13 (25.5)

4. Discussion application, and at the first month after application were

The TDP method has been known for a long time and 59.2, 44.8, and 33.4, respectively (P < 0.001, Table 3). The
is used in many medical fields such as nicotine and median of VAS values before the application, on the third
postmenopausal hormone replacement, pain treatment, day after application, and at the first month after application
and antihypertension medications (12). Fentanyl has been were reduced to 9, 7, and 5. These values support the
used transdermally in LDHR treatment and recovery of efficiency of ADP treatment. The mechanism of action
symptoms of patients has been reported (13,14). However, of ADP is supposed to be by reducing the osmolarity of
the method that we used in this case is a completely the disc by the fatty acids that reach the disintegrated disc
new approach in which the ADP enhances the systemic and have a lower solute concentration than water. Thus,
circulation. The findings of this study suggest that the the fatty acids were formed with dextrin palmitate, which
disintegrated herniated disc absorbs the active ingredients reaches the herniated nucleus pulposus and produces a
by diffusion and this decreases the intraosmotic pressure hypoosmolar medium. The water inside the herniated
of the herniated nucleus pulposus and results in water loss. nucleus pulposus passes to the hyperoosmolar medium so
According to the findings of this study, the patients that the water content of the disc decreases and the mass
in the treatment group with sciatica and LDHR showed reduces.
significantly important clinical recoveries when compared In the literature, there are publications indicating
with the control group in regards to baseline values. When that even massive herniated discs can be reduced and
we examined the difference before application and at reabsorbed by long-term follow-ups by conservative
the third day after application, there was a significantly treatment (15 – 21). Significant reduction of symptoms
higher recovery rate in the ADP group than the control in conservatively followed patients is seen in the long
group regarding the ODI scores, VAS values, and physical term (16–18). Comparing the conservative and surgical
examination findings. For the patients in the ADP group, treatments for LDHR patients, there is no superiority of
ODI scores before the application, on the third day after surgery over long-term conservative treatment (22).

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Table 3. The data before and after application in the experiment group. General linear model-repeated ANOVA (Wilks’ lambda); post
hoc test: LSD; Cochran’s Q test; post hoc test: nonparametric Miller post hoc test. Average data ± standard deviation; median (range);
n (%).

Preoperative = I 3rd day = II 1st month = III P-value

n = 40 n = 40 n = 40 I–II I–III II–III General

ODI 59.2 ± 13.37 44.8 ± 15.61 33.4 ± 10.13 <0.001 <0.001 <0.001 <0.001
VAS 9 (3–10) 7 (2–10) 5 (2–10) <0.001 0.042 <0.001 <0.001
SLR Positive 32 (80.0) 16 (40.0) 4 (10.0) 0.001 <0.001 0.016 <0.001
Negative 8 (20.0) 24 (60.0) 36 (90.0)
K-SLR Positive 32 (80.0) 16 (40.0) 4 (10.0) <0.001 0.001 0.016 <0.001
Negative 8 (20.0) 24 (60.0) 36 (90.0)
Flexion Normal 15 (37.5) 25 (62.5) 33 (82.5) 0.019 <0.001 0.085 <0.001
Disabled 25 (62.5) 15 (37.5) 7 (17.5)
Extension Normal 14 (35.0) 25 (62.5) 32 (80.0) 0.006 <0.001 0.148 <0.001
Disabled 26 (65.0) 15 (37.5) 8 (20.0)
Right lateral flexion Normal 17 (42.5) 28 (70.0) 32 (80.0) 0.003 <0.001 0.704 <0.001
Disabled 23 (57.5) 12 (30.0) 8 (20.0)
Left lateral flexion Normal 17 (42.5) 28 (70.0) 32 (80.0) 0.003 <0.001 0.704 <0.001
Disabled 23 (57.5) 12 (30.0) 8 (20.0)
Paravertebral muscle
Yes 40 (100.0) 12 (30.0) 8 (20.0) <0.001 <0.001 1 <0.001
spasm
No 0 (0.0) 28 (70.0) 32 (80.0)
Femoral stretching test Positive 31 (77.5) 15 (37.5) 6 (15.0) <0.001 <0.001 0.082 <0.001
Negative 9 (22.5) 25 (62.5) 34 (85.0)

The pain of the patient may partially increase after the before ODI administration suggests that the clinical status
8th hour of ADP application until the 24th hour after the of the groups may be similar.
application. We inform the patients about this in order to Transforaminal endoscopic discectomy and
ensure their compliance. The reason for this may be that microdiscectomy were performed in a study conducted
the hypoosmolar fatty acids diffuse to the herniated disc with the patients’ ODI values, in which the preoperative
and increase the volume of the disc during the first 24 ODI value of transforaminal endoscopic discectomy
h. We generally see that the symptoms start to decrease patients was 43 and the postoperative ODI value was
after this period when the diffusion of water starts due to 22, and the preoperative ODI value of the patients who
hypoosmolarity. We also saw that clinical recovery is better underwent microdiscectomy was 43 (24). In another study,
at the end of the first month of ADP application than at 31 patients underwent laser-assisted discectomy and the
the third day. This finding supports the hypothesis that the patients were assessed by preoperative and postoperative
hypoosmolar property of the disc is maintained until the ODI scales. The preoperative ODI value of the patients
end of the first month. was measured as 60 postoperative ODI values ​​of 11 (25).
Although we did not randomize the groups, we found According to Ahn et al., tubular discectomy used in
that the only statistically lumbar disc herniation was evaluated and preoperatively
significant difference between the two groups before the ODI score was 84, while the postoperative ODI score
the application was the higher rate of paraspinal muscle was 27 (26) In our study, the ODI score fell from 59 before
spasm in the ADP group. Paraspinal muscle spasms may application to 33 after application. When considering
occur when the disc hernia is especially anterior to root the possible complications and costs of all these surgical
irritation (23). In addition, the fact that the disc herniation methods, it is thought that TDP application is effective in
is added to other possible physical examination findings lumbar disc hernia treatment.
may lead to the patient feeling more pain. However, the Proper patient selection is also an important factor
statistically significant difference between the groups in the success of clinical treatment of LDHR patients

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Table 4. The data before application and 3rd day after application in control group. Independent t-test
(bootstrap) - Mann–Whitney U test (Monte Carlo) - Fisher exact test (exact). Average data ± standard
deviation; median (range); n (%).

Control
P-value
Preop 3rd day
ODI 61.8 ± 11.42 52.2 ± 12.5 <0.001
VAS 8 (3–10) 7 (2–10) <0.001
Positive 29 (74.4) 25 (64.1) 0.219
SLR
Negative 10 (25.6) 14 (35.9)
Positive 29 (74.4) 24 (61.5) 0.063
K-SLR
Negative 10 (25.6) 15 (38.5)
Normal 17 (43.6) 18 (46.2) 1
Flexion
Disabled 22 (56.4) 21 (53.8)
Normal 17 (43.6) 18 (46.2) 1
Extension
Disabled 22 (56.4) 21 (53.8)
Normal 16 (41.0) 18 (46.2) 0.500
Right L flexion
Disabled 23 (59.0) 21 (53.8)
Normal 17 (43.6) 19 (48.7) 0.500
Left L flexion
Disabled 22 (56.4) 20 (51.3)
Yes 30 (76.9) 21 (53.8) 0.004
Paravertebral muscle spasm
No 9 (23.1) 18 (46.2)
Positive 27 (69.2) 20 (51.3) 0.016
Femoral stretching test
Negative 12 (30.8) 19 (48.7)

Table 5. The difference between groups before application and the third day af-
ter application .General linear model-repeated ANOVA (Wilks’ lambda) - inde-
pendent t-test (bootstrap) - Mann–Whitney U test (Monte Carlo) - Fisher exact
test (exact). Average data ± standard deviation; median (range); n (%). Odds
ratio (95% confidence interval for odds ratio); º: reference taken for odds ratio.

Control Experiment P-value

ODI Preoperative 61.8 ± 11.42 60.9 ± 13.15 0.724
3rd day 52.2 ± 12.5 46.0 ± 15.4
difference 8.2 ± 7.7 14.2 ± 12.9 0.010
VAS Preoperative 8 (3–10) 10 (3–10) <0.001
3rd day 7 (2–10) 7 (2–10)
difference 1 (2–4) 2 (1–8) 0.003

when comparing the physical examination results, ODI mechanic vertebral instability, protrusion, calcification,
scores, and VAS values of ADP-treated patients with lateral access stenosis, advanced motor deficit, or sphincter
the control group. We prefer the ADP in patients with defects.
clinically diagnosed sciatica with LDHR and radiologically Our study had some limitations. Even though
diagnosed protruded and extruded discs. From the there was a placebo control group, comparisons with
location point of view, it should be applied to the patients other control groups such as other lumbar disc hernia
with central and posterolateral disc hernias. It should not treatments (surgery, epidural steroid injection, etc.) could
be applied to patients with stenosis in the vertebral canal, increase the power of the study. A longer study period may

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provide more information about the efficacy of the ADP. may become a candidate for alternatives of conservative
Additionally, studies that show the efficacy of the ADP treatment of LDHR. Clinical trials with more subjects and
radiologically could provide more objective data. a longer period have to be performed in order to support
In conclusion, ADP application has achieved successful the effectiveness of the ADP in the treatment of lumbar
clinical results for the conservative treatment of LDHR. It disc herniation.

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