Cooled RF Study Presentation

Use of Cooled Radiofrequency Lateral Branch Neurotomy for the treatment of Sacroiliac Joint Mediated Low Back Pain: A Large Case Series W. Stelzer, Med. Zentrum SchmerzLOS Linz und Baden/Vienna – Austria; H. Wagner, JK Universität Linz; M. Aiglesberger, D. Stelzer; V. Stelzer, Med. Zentrum SchmerzLOS Linz / Baden/ Vienna – Austria Medicent Linz
Untere Donaulände 21-25, A-4020 Linz
Tel.:
+43 (0) 732 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
Medicent Baden / Wien
Grundauerweg 15, A-2500 Baden/Wien
Tel.:
+43 (0) 2252 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
E-Mail: schmerzlos@gmx.at
Medicent Linz
Untere Donaulände 21-25, A-4020 Linz
Tel.:
+43 (0) 732 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
Medicent Baden / Wien
Grundauerweg 15, A-2500 Baden/Wien
Tel.:
+43 (0) 2252 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
E-Mail: schmerzlos@gmx.at
What is SIJ pain? The pain paDern associated with sacroiliac joint syndrome typically includes: ×  Joint pain in the sacroiliac region ×  Tenderness overlying the joint which may be accompanied by buFock, posterior thigh, and/or groin pain ×  The clinical presentaIon and funcIonal limitaIons of those with sacroiliac joint syndrome is similar to that of other common causes of low back pain1 Sacroiliac joint pain is diagnosed through an iteraFve process that includes: ×  History and physical ×  Imaging and eliminaIon of other possible pain generators × 
(intervertebral discs, zygapophysial joints, muscular hyperacIvity) ×  Fluoroscopically guided sacroiliac joint blocks and/or lateral branch blocks 3 Sacroiliac Joint Pain -­‐ Prevalence × 
“…the prevalence of SI joint pain in carefully screened LBP paIents appears to be in the 15%–
25% range” (Cohen, 2005) × 
SI pain prevalence is 32% based on single IA injecIon (Katz 2005, Maigne 2005) × 
No true difference exists in the health related quality of life scores between those with SIJ pain or lumbar radiculopathy (Cheng, 2006) × 
AssociaIon with Lumbosacral Fusion: -­‐Has been associated with pain developing post lumbo-­‐sacral fusion4,5 -­‐Incidence of SIJ pain post L/S fusion found to be 32%5 -­‐SIJ degeneraIon observed in 75% of post lumbar fusionpaIents (n=37)6 Cohen (2005) Anesth Analg;101: 1440-­‐1453 Katz (2003) J Spinal Disorders 16;96-­‐99. Maigne (2005) Euro Spine J 14;654-­‐658. Cheng (2006) Reg Anesth Pain Med;31:422-­‐427 SIJ Osseous Anatomy Schuenke et al. Thieme Atlas of Anatomy General Anatomy and Musculoskeletal
System. All rights reserved. © THIEME 2007, www.thieme.com
SIJ Ligamentous Anatomy Schuenke et al. Thieme Atlas of Anatomy General Anatomy and Musculoskeletal
System. All rights reserved. © THIEME 2007, www.thieme.com
SIJ Neuroanatomy/InnervaIon × 
Ikeda (1991) 18 Japanese cadavers
×  Ventral surface innervated by VR of L5-S2 or
branches from the sacral plexus.
×  Dorsal surface innervated by the L5 DR and S1-4
lateral branches
× 
Willard (1991) 10 cadavers.
×  L5 DR, S1 and S2 lateral branches primarily innervate
the SIJ and associated dorsal ligaments
×  Occasional contributions from S3 but not S4
Ikeda, J Nippon Med School, 58:587,1991
Willard. Third World Congress on Low Back and Pelvic Pain. Vienna, Austria, November, 1998
SIJ InnervaIon-­‐ Lateral branches S1-­‐S2-­‐S3 S1
× 
× 
S2
S3
Method: Copper rings placed in PSFA, wires placed over lateral brs. w/Xray Findings: × 
Nerve locaIons variable -­‐ Person to Person, Side to Side, Level to Level × 
Nerves 0-­‐2 mm superficial to dorsal sacrum, span 120 degrees of arc × 
Far lateral to the foramina, lateral branches enter posterior ligaments Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-­‐2425. Images reprinted with permission of LippincoF Williams, 2007. SIJ Innervation
Cohen 2009 •  The SI joint and posterior ligament complex are innervated by lateral branches of the S1-­‐S3 dorsal ramus and the L5 dorsal ramus proper8,9,10 •  The locaIon and number of lateral branches are inconsistent11, making this a challenging target for RF •  InnervaIon is variable and may also include anterior primary rami How do we Diagnose SIJ Pain? × 
Best clinical screening test is maximum pain below
L5 coupled with pointing to the PSIS (Fortin finger
test) or tenderness just medial to the PSIS (60% PPV)
(Dreyfuss, Slipman)
× 
Provocation maneuvers are informative, but not
reliably diagnostic (Laslett, van der Wurff)
× 
Imaging is informative, but not reliably diagnostic
Dreyfuss P, Spine 1996; 21:2594-2602
Slipman C, Arch Phys Med Rehabil, 1998; 79:288-92
Laslett (2005). Manual Therapy 10;207-218
van der Wurff (2006). Arch Phys Med Rehab 87;10-14
Diagnosis-­‐ IA InjecIon vs. lateral branch blocks × 
× 
× 
× 
Dual SIJ injecIons remain tradiIonal for diagnosis of IA SIJ pain. Single SIJ injecIons reported as 20% false posiIve. IA SIJ injecIons must be performed with fluoroscopic imaging (Rosenberg 2000) Some painful SIJ demonstrate only short term pain relief due to local anestheIc effect without durable steroid response. Capsular tears may prevent anestheIc from reaching painful regions of SIJ, reducing diagnosIc sensiIvity. Obtain AP, lateral, slight obliques to note ventral/posterior capsular tears SI injecIon might not predict RF results if anterior innervaIon is significant – results of Cohen 2008 suggest this is uncommon. Cohen Anesthesiology 2000;109:279-­‐88. Hansen Pain Physician 2007;10(1);165-­‐184. RosenbergThe Clinical J of Pain 2000;16:18-­‐21. Results of non-­‐cooled SIJ RF × 
Monopolar sensory sImulaIon guided RF (n=14) 64%-­‐88% with >50% pain relief at 6-­‐9 month f/u and 36% pain free at 6 mo f/u (retrospecIve sensory guided single lesions )
× 
× 
× 
× 
Bipolar periforaminal RF (n=9) 33% with >50% pain relief, ODI decrease 18, but 67-­‐89% saIsfied at 6/9 months × 
× 
Yin. Spine 2003;28:2419-­‐2425 Cohen. Reg Anest Pain Med 2003;28:113-­‐119 Buijs. The Pain Clinic 2004;16:139 Burnham, Reg Anesth Pain Med 2007;32:12-­‐19 Bipolar “Palisade” technique. (n=4) results not provided “Clinical outcomes are posiIve, but have so far only been assessed informally over a short Ime.” × 
× 
Cosman, Pain Pract 2011;11:3-­‐22. No published data for Simplicity mulI-­‐electrode bipolar device as of December 1, 2011. TM
Cooled Radiofrequency -­‐ SInergy System × 
What makes SInergy cooled RF novel and theoreIcally more aFracIve than prior LB RF techniques including tradiIonal (sensory guided) or bipolar RF? × 
Can we obtain superior and/or more predictable results with equal or less risk from use of cooled-­‐RF probe technology? Selection of optimal RF probe technology
Standard 18 G RF cannula
Ellipsoidal volume
2.5 mm radius
Major axis parallel to tip
No distal projection of lesion
18 G cooled Sinergy probe
Near spherical volume
5.0 mm radius
40% of lesion DISTAL to tip
Cooled-­‐RF Lesion ProperIes × 
× 
Uniform lesions formed in non-­‐homogeneous Issue Lesion CharacterisIcs accommodate for inconsistent and variable innervaIon Cooled-­‐RF Lesion ProperIes × 
Distal projecIon allows virtually idenIcal near-­‐spherical lesions without regard to angle of trocar approach to dorsal sacrum × 
Cooled-­‐RF lesion volume equivalent to 6-­‐8 convenIonal RF lesions Cooled-­‐RF Lesion Summary •  Large cooled-RF
lesions are positioned in
a lateral arc around
each dorsal sacral
aperture
•  Nine targets create a
combined lesion volume
adequate to
compensate for LBs
varied number and
course
Use of Cooled Radiofrequency Lateral Branch Neurotomy for the treatment of Sacroiliac Joint Mediated Low Back Pain: A Large Case Series W. Stelzer, Med. Zentrum SchmerzLOS Linz und Baden/Vienna – Austria; H. Wagner, JK Universität Linz; M. Aiglesberger, D. Stelzer; V. Stelzer, Med. Zentrum SchmerzLOS Linz / Baden/ Vienna – Austria Medicent Linz
Untere Donaulände 21-25, A-4020 Linz
Tel.:
+43 (0) 732 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
Medicent Baden / Wien
Grundauerweg 15, A-2500 Baden/Wien
Tel.:
+43 (0) 2252 / 9010 – 1040
Mobil: +43 (0) 660 / 90 10 10 40
E-Mail: schmerzlos@gmx.at
Sacroiliac joint (SIJ) pain × 
Prevalence of sacroiliac joint (SIJ) pain chronic axial low back pain is reported to be between 18% and 30%. × 
Difficult to diagnose because it can be confused with referred pain from other low back structures. × 
This is the first study to examine the efficacy of Cooled RF LBN in a European populaIon, and also the first study to report study outcomes up to 20 months in duraIon Methods × 
Electronic records of 126 paIents with chronic low back pain who underwent treatment with Cooled RF LBN were idenIfied. -­‐ 
× 
ConsecuIve subjects treated with Cooled RF LBN between January 7th, 2008 and May 26th, 2009. SelecIon Criteria for Cooled RF -­‐
-­‐
-­‐
-­‐
-­‐
-­‐
Chronic low back pain for longer or equal to 6 months; Pain localized in the SIJ region; signs and symptoms of SIJ mediated low back pain upon physical examinaIon; Visual analogue scale (VAS) pain score of greater or equal to 5 Previously failed to achieve adequate improvement with conservaIve non-­‐invasive treatments; PosiIve response (≥50% pain relief) from a single fluoroscopically confirmed intra-­‐arIcular SIJ injecIon. Excluded if received pain relief for a duraIon longer than what could be achieved with lidocaine SIJ injecIon; and, if they had incorrect expectaIons Methods × 
Cooled RF Lateral Branch Neurotomy × 
Lesioning the L5 dorsal ramus (L5DR) and lateral to the S1, S2 and S3 posterior sacral foraminal aperatures. × 
Outcomes collected before the procedure, at 3-­‐4 weeks post-­‐
procedure (n =97), and between 4-­‐20.3 months post-­‐
procedure (n = 105) -­‐
-­‐
-­‐
-­‐
Visual analog scale (VAS) pain scores, Quality of life, MedicaIon usage and SaIsfacIon. Methods × 
126 charts were reviewed. -­‐
-­‐
-­‐
-­‐
-­‐
-­‐
× 
Charts were required to have a VAS pain score recorded before treatment and once again between 4 and 20.3 months post-­‐treatment. 21 of the 126 charts had incomplete data: 9 subjects were lost to follow-­‐up, 2 had psychological barriers to reporIng outcomes, 3 had incomplete records, and 7 had confounding pain generators or disease states which prevented follow-­‐up 105 charts were eligible for analysis. -­‐
-­‐
-­‐
-­‐
-­‐
97 of 105 charts had VAS pain score data for the 3-­‐4 week Ime point. To assess the durability of response to treatment over Ime, subjects were straIfied according to the Ime to final follow-­‐up: 4-­‐6 months (mean 4.9 ± 0.7 months) (n = 26), 6-­‐12 months (mean 7.9 ± 1.6 months) (n = 45), and >12months (mean 17.5 ± 2.8 months) (n = 34) Results × 
No serious complicaIons were observed × 
Post-­‐procedural recovery was consistent with other RF procedures. × 
Mean VAS pain score dropped from 8.15 ± 1.22 to 1.58 ± 1.72 at 3-­‐4 weeks auer treatment (n = 97) (P < 0.001) Results Demographics 4-6 months
follow-up group
Feature
(n = 26)
Age
66 ± 11.5
Gender
15% male, 85%
female
Baseline Opioid Users 5
Bilateral
0
VAS Before Diagnostic 8.52 ± 1.07
Block
VAS After Diagnostic
1.21 ± 1.38
Block
VAS at 3-4 Weeks After 1.59 ± 1.44 (n = 24)
Treatment (n = 97)
Surgery before study
92% none;
8% minimally
invasive or open
surgery;
0% spinal fusion
6-12 months
follow-up group
(n = 45)
67 ± 14.0
36% male, 64%
female
13
0
8.07 ± 1.11
>12 months
follow-up group
(n = 34)
70 ± 12.3
26% male, 74%
female
15
1
7.99 ± 1.44
P Value
1.42 ± 1.28
2.10 ± 1.40
1.50 ± 1.86 (n = 42)
1.69 ± 1.76 (n = 31) 0.898
64% none;
19% minimally
invasive or open
surgery; 17% spinal
fusion
77% none;
23% minimally
invasive or open
surgery; 0% spinal
fusion
0.437
0.184
0.107
--0.209
0.025
0.032
Results Pain Mean visual analogue scale (VAS) pain scores at baseline and at 3-­‐ 4 week s auer treatment with Cooled Radiofrequency Lateral Branch Neurotomy , for 97 subjects with 3-­‐ 4 week follow -­‐up data. Whiskers represent standard deviaIon. *P < 0.001 as compared with baseline VAS scores Results Pain Mean visual analogue scale (VAS) pain scores at baseline and at final follow-­‐up, with subjects stratified according to time to final follow-­‐up. Whiskers represent standard deviation. *P < 0.001 compared with baseline of the respective group. Results Pain Percentage of subjects who achieved ≥50-­‐100% visual analogue scale (VAS) pain score reduction, with subjects stratified by time to final follow-­‐up Results Pain Feature
4-6 months
6-12 months
>12 months
follow-up group follow-up group follow-up group
(n = 26)
(n = 45)
(n = 34)
5-Point VAS Decrease
% (95% CI)
77 (61-93)
67 (53-81)
32 (16-48)
2-Point VAS Decrease
% (95% CI)
92 (82-100)
84 (73-95)
74 (59-89)
Proportion of Subjects Achieving 5-­‐Point Decrease in Visual Analogue Scale (VAS) Pain Scores, and 2-­‐Point Decrease in VAS Pain Scores, with Subjects Stratified by Time to Final Follow-­‐Up Results Quality of life Patient-­‐reported quality of life outcomes at final follow-­‐up, with subjects stratified by time to final follow-­‐up Results MedicaIons Percentage of baseline opioid and NSAID users who stopped or decreased use, with subjects stratified by time to final follow-­‐up Discussion × 
Results of this retrospecIve case series suggest that Cooled RF LBN is an effecIve treatment opIon for chronic back pain originaIng in the SIJ complex. × 
The durability of pain relief reported in this study is consistent with other studies of RF neurotomy for SIJ mediated back pain and lumbar facet pain with mid-­‐ to long-­‐term follow-­‐up. × 
LimitaIons of this study -­‐
-­‐
-­‐
-­‐
-­‐
retrospecIve cohort: no control group to account for confounders, such as the placebo effect; difficulty in contacIng certain subjects; and, missing data for some subjects. variable length of Ime to final follow-­‐up, however homogeneity among the follow-­‐up groups allows a reasonable assessment of procedural durability. Conclusion × 
This is the first published study on Cooled RF LBN to report outcomes in a European populaIon and the first to report outcomes up to 20 months in duraIon. × 
These results further support the recommendaIon of Cooled RF LBN as the treatment opIon for subjects who are not able to achieve adequate benefit from conservaIve medical management or therapeuIc SIJ injecIons. × 
The decreases in chronic pain and medicaIon usage, along with the improvement in quality of life and high amount of treatment saIsfacIon, may jusIfy the use of Cooled RF equipment in a broader populaIon.