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Austrian Pain Intervention
Centers
Linz and Baden/Vienna
www.schmerz.cc
Austrian Pain Intervention Centers
Linz and Baden/Vienna
The influence of BMI and gender on pain decrease and medication usage after
Facet – Medial Branch or SI Joint Lateral Branch Neurotomy (cooled RFSInergy) in case of Facetjoint or SI Joint mediated low back pain.
A large Case series of low back pain RF Treatment
(The Austrian Experience)
Wolfgang Stelzer, MD,* Dominik Stelzer,MD* , Valentin Stelzer*,Mag.,Monika Braune, MD,*;
Christine Duller, Univ. Prof., MMag. DI. Dr.§
www.schmerz.cc
Objective
This retrospective study was designed to illustrate the general
outcome after radiofrequency neurotomy of lumbar medial branches
and rami posterior of the SI Joint in patients with low back pain 1, 6
and 12 months after treatment. Outcomes were stratified by BMI,
gender and age to determine their effect on the reduction of opioids
and NSAIDS.
Subjects and Setting
164 patients with chronic low back pain who underwent treatment
with RF medial branch and/or cooled RF LBN. Three pain clinics
Austria
Design
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The records of 164 patients with chronic low back pain who underwent
treatment with RF medial branch Neurotomy (parallel needle technique)
and/or cooled RF LBN in case of SI Joint mediated low back pain were
identified. Subjects were selected for treatment based on physical
examination and positive response (>50% pain relief) to an lumbar medial
branch block/Ramus dorsalis L5 block or intraarticular SIJ block.
Lumbar medial branches L3 and L4 and the ramus dorsalis L5 were
lesioned in „ISIS“ parallel needle technique (N=36). Cooled RF LBN
involved lesioning the L5 dorsal ramus and lateral to the S1, S2, and S3
posterior sacral foraminal apertures (N=87).
Design
•
Visual analog scale (VAS) pain scores, quality of life, BMI, medication
usage, and satisfaction with pain management were collected before the
procedure, at 1 month postprocedure (N = 164), and again after 6 (N= 75)
and 12 months (N=89) postprocedure.
RF Technique lumbar Facet Joint medial branch
•
Parallel needle technique (ISIS technique)
Technique SIJ
Total of 9 lesions were created during the procedure: one at the L5
dorsal ramus, 3 lateral to the S1 and S2 sacral foramina, and 2 lateral to
the S3 sacral foramen.
Methods
All subjects qualified for treatment based on physical
examination and positive response to testblock. Data
collected included; Visual Analog Scale pain scores, quality
of life, BMI, medication usage, and satisfaction with pain
management before procedure, at 1, 6 and 12 months.
•
•
For tests of normality of the data, the Kolmogorov-Smirnov-Test (KS-test)
as well as the Shapiro-Wilks-Test (SW-test) were used. As both tests
showed significant results and therefore assumption of normal distribution
did not hold for our variables, a test on differences in location were made by
the nonparametric Wilcoxon Test.
In many cases (if requirements of central limit theorem were fulfilled) we
also conducted an additional paired t-test.
•
summarized VAS for the whole
sample before treatment (prae),
one month after treatment (mts)
as well as later after treatment (6
or 12 months) and shows the
number of cases, the estimators
for mean and standard deviation,
and the two-sided p-values for
tests of normality (both
Kolmogorv-Smirnov-test and
Shapiro-Wilks-test)
VAS
prae
mts
yr
130
161
163
8,004
4,273
4,304
1,42
2,18
2,49
KS-Test
0,001
0,000
0,000
SW-Test
0,000
0,000
0,000
Cases
Estimators
mean
standard deviation
p-values (2-sided)
Statistical Analysis
•All analyses were performed using SPSS version 22. Descriptive statistics
were used to give in data summary of variables illustrating: the number of
cases, mean, standard deviation (SD), minimum, maximum and all quartiles
(i.e. 0.25 percentile, median, 0.75 percentile). Tables of confidence intervals
contain information on the mean, standard deviation (SD), standard error (SE),
upper and lower bound of the interval, as well as the two sided p-value for a ttest (test value 0).
•All statistical tests were conducted on a significance level of alpha = 5%.
Statistical Analysis
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All 857 treated patients (09/2012-06/2014) were sent a questionnaire (with
self-addressed return envelope) after 6 months, and 12 months ( 09/201312/2014) .
193 sent back the form . (22,5%)
29 Exclusion Criterias (false filled out form, other health problems like
internal deseases,..)
31 with some missing data and
131 completly filled form with all dataThere were no severe or moderate
complications during or after the procedures.
Results
•
VAS decrease of 4 points on 10 point scale (8 to 4) was demonstratedafter
6 months and 4.5 after 12 months. Lower medication usage was
demonstrated with a decrease in opioids by 40%, and NSAIDS by 60%.
Decrease in reported pain was shown to last for 12 months.Data illustrate
significant better outcomes for patients with BMI lower than 30.Nogender
specific difference in decrease in VAS. All reported complications were mild
and spontaneously resolved.
Results
VAS Reduction total group
The results indicate a reduction in all groups 1, 6
and 12 months after treatment and a small
increase between 6 and 12 months (4.082 up to
4.556).
Results
Medication Usage
•
It could be shown that in all
groups the patients required less
medication for pain management
in the follow up period. For all
patients, 106/164 (64.7%) needed
less medication, just 1/164 (0. 7%)
needed more. NSAIDS reduction
was possible for 48/78 (62%), in
the opioid users group 14/37
(38%) were able to reduce or stop
the medication after treatment.
Opioids
(n = 37)
NSAIDS
(n = 78)
0%
50%
less
same
100%
more
Results
sorted by area (lumbar
facets and SI Joint)
•
The results are nearly equal
between patients treated on the
lumbar medial branches ( 18G,
1cm active tip, parallel technique)
and SI Joint (cooled RF
Treatment, Halyard Health) for
VAS (Table 2), and medication
usage (NSAIDS and opiodis)
Group
LWS
6
12
ISG
6
12
VAS
N
Mean SD
Percentiles
25.
50.
75.
prae
11
7,7
1,7
7,0
8,0
9,0
mts
11
4,8
1,9
3,0
5,0
5,0
yr
11
3,0
2,8
1,0
1,5
5,0
prae
24
7,9
1,3
7,0
8,0
8,0
mts
24
4,2
2,1
3,0
3,5
5,9
yr
24
4,8
2,3
2,6
5,0
7,0
prae
35
8,2
1,4
7,0
8,0
9,5
mts
34
4,1
2,1
3,0
3,3
5,3
yr
35
4,6
2,5
2,0
4,5
6,5
prae
52
8,0
1,5
7,0
8,0
9,0
mts
51
4,1
2,2
2,0
3,0
6,0
yr
52
4,5
2,7
2,0
5,0
6,8
Results
BMI Dependence
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Separated in two groups (BMI <30
and BMI > 30) a difference is
noted in VAS decrease and quality
of life
VAS
100%
10
80%
8
60%
6
40%
4
20%
2
0%
0
BMI ≤ 30
(normal)
better
same
BMI > 30
worse
BMI ≤ 30
(normal)
VAS prae
BMI > 30
VAS late
Results
Confidence Interval
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The 95% Confidence
Interval of difference
VAS pre versus 1
month 3,3 -4,2 ;
VAS
pre
versus
6/12month 3,1-4,1,this
shows that patients
have a 95% probability
to get a pain decrease
about 3,1-4,1 points
on the VAS Scale after
treatment.
VAS Difference Mean
SD
SE
95% CI
lower
upper
p-value
prae - 1 mth
3,74
2,56
0,23
3,29
4,19
0,000
prae - 6/12 mth
3,62
2,79
0,25
3,14
4,11
0,000
1 mth - 6/12 mth -0,08
2,74
0,22
-0,51
0,34
0,697
Results
VAS
The Influence of Sex
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In an analysis of VAS decrease by
gender, our results are
approximately the same in the
male (n=53) and female (n=106)
group (Tbl.6).
Analysis of satisfaction (“quality of
life” better/equal/worse) the
results reveal high satisfaction in
the female group.
100%
10
80%
8
60%
6
40%
4
20%
2
0%
0
male
better
same
female
worse
male
VAS prae
female
VAS late
Conclusions
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The durability of pain relief reported in this study is consistent with other studies
of RF neurotomy for SIJ- mediated low back pain and lumbar facet joint mediated
low back pain[1],[2],[3],[4],[5] The decreases in chronic pain and medication usage
may suggest the use of RF treatment in case of low back pain as a proper
treatment option as well as the probability of 95% to have a VAS decrease of 3-4
points on the NAS (0-10) scale. Pain decrease can be shown for at least 12 months.
•
[1] Patel, Nilesh, et al. "A Randomized, Placebo‐Controlled Study to Assess the Efficacy of Lateral Branch Neurotomy for
Chronic Sacroiliac Joint Pain." Pain Medicine 13.3 (2012): 383-398.
[2] Schofferman J, Kine G. Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain. Spine
2004;29(21):2471–3.
[3] Hagg O, Fritzell P, Nordwall A. The clinical importance of changes in outcome scores after treatment for chronic low back
pain. Eur Spine J 2003;12(1):12–20.
[4] Patel N, Gross A, Brown L, Gekht G. A randomized, placebo controlled study to assess the efficacy of lateral branch
denervation for chronic sacroiliac joint pain. Pain Med 2012;13:383–98.
[5] Nikolai Bogduk, MD, PhD, DSc, Paul Dreyfuss, MD,ayantilal Govind, MB, ChB, Mmed; Pain Med. 2009;10:1035-1045,A
Narrative Review of Lumbar Medial Branch Neurotomy for theTreatment of Back Pain
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Conclusions
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Limitations of this study are those that apply to all retrospective studies: no
control group to account for confounders, such as the placebo effect, but
the results are better than what we would expect for the placebo effect;
difficulty of a small percentage of subjects to fill out the questionnaire and
return it to the investigative staff; and missing data for some subjects.
The decreases in chronic pain and medication usage may suggest that the
use of Radio Frequency treatment would serve as the first option in
standard of care for the treatment of low back pain with a 95% probability of
a significant decrease in pain (3-4 points on the NAS 0-10 scale) that may
last for at least 12 months.
Conclusions
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The results of lumbar medial branch neurotomy with the parallel needle
technique seem to be as good as the results achieved with the SI Joint
mediated low back pain with the cooled RF-Probe (Halyard Health)
•
Overall, the authors have determined that treatment with RF methods for
patients with chronic low back pain is a safe, durable effective long term
pain and analgesic reduction treatment option. Public insurance should be
motivated to provide for reimbursement as a safe and reliable method for
the treatment of low back pain.
Austrian Pain Intervention
Centers
Linz and Baden/Vienna
www.schmerz.cc