lorangerie 23 10 12 00 leonardo kapural (simposio optika).ppt

Coolief: Radiofrequency treatment for sacroilitis, Discogenic pain and thoracic facet denervation

Leonardo Kapural, MD, PhDCarolinas Pain Institute and Center for Clinical ResearchProfessor of Anesthesiology, Wake Forest University School of Medicine

Chronic sacroiliac joint pain: The problem

• 217 pts- pain below L5

• Twice positive (>75% relief) SIJ blocks

• Prevalence of SIJ pain was 10-20%

• (Schwarzer 1995, Maigne 1996)

• 74 patients-persistent lower back pain after LS fusion, SIJ-pain source in 32% (single SIJ injection)

• (Katz 2005, Maigne 2005)

Maigne (1996) Spine 21:1889.

Schwarzer (1995) Spine 20:31-37.Katz (2003) J Spinal Disorders 16;96-99.Maigne (2005) Euro Spine J 14;654-658

Functional impairment

• Comparable to patients with chronic radiculopathy:

• Retrospective

• SF-36 scores- SIJ pain vs lumbar radiculopathy

• No true difference exists

Cheng (2006) Reg Anesth Pain Med;31:422-427

SIJ Innervation Studies

• 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

• (Ikeda, J Nippon Med School, 58:587,1991)

SIJ Innervation Studies

• Willard (1991) 10 cadavers.

• S1 and S2 lateral branches primarily innervate the SIJ and associated dorsal ligaments, occasional contributions from S3 but not S4.

• (Willard. Third World Congress on Low Back and Pelvic Pain. Vienna, Austria, November, 1998)

S1-4 Dorsal Rami and Divisions

Dr. FrankWillard

Midline

PSIS

S1

S2

S3

S4

Left

LDSIlig.

Interforaminal neural arcade

Lateral branches

• Joint is predominantly, innervated by posterior primary rami1,3,4

• Nerve location is variable: 2,5

– Person to Person– Side to Side– Level to Level

• Nerves may run along bone, or up to 8 mm superficial from the sacrum 5

SI Joint Innervation

Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.

• 1Cohen S. Anesth Analg. 2005: 101: 1440-1453;

• 2Yin W. et al. Spine. 2003; 28(20):2419-2425

• 3Grob K. et al. Z Rheumatol. 1995;27:117-122;

• 4Fortin J. et al. Spine. 1994;19(13):1475-1482

• 5Willard F. et al. World Congress on Low Back and Pelvic Pain. Vienna, Austria, 1998

SI Joint Innervation

Yin W, Willard F, Carreiro J, Dreyfuss P (2003) Spine 28:2419-2425. Images reprinted with permission of Lippincott Williams, 2007.

S1

S3

S2

Present Standard for SIJ Diagnosis:

• Require dual positive (>80% relief) SIJ injections (+/- steroid)

• Strongly consider excluding other anatomic structures as pain generators (e.g. MBBs +/- discography if MRI abnormal) before SIJ RFN

“Leapfrog” Technique for SIJ RF

• Retrospective study on 30 patients who underwent 50 RF denervations of the joint

• Lesions made in the postero-inferior aspect of joint by ‘leapfrogging’ RF probe at < 1cm intervals

• 12 of 33 patients (36.4%) obtained > 50% pain for at least 6 months (mean duration of pain relief 12+/- 1.2 months)

• Ferrante et al. Reg Anesth Pain Med 2001

Sensory Stimulation-Guided SI Joint Radiofrequency Neurotomy

• Retrospective study in 14 patients who obtained > 70% relief following 2 SIJ deep interosseous ligamentous injections

• All pts had L5 dorsal ramus and S1 lateral branch lesioned. 11 pts had S2 and 6 S3 lateral branch lesioned

• 64% of pts obtained > 50% pain relief @ 6 months, with 36% achieving complete relief

• Yin et al. Spine 2003

Bipolar “Strip” Lesion

• 9 pts with a “bipolar strip” lesion at lateral dorsal foramina + conventional monopolar lesion of L5 dorsal ramus

• 33% with >50% pain relief and decreased analgesic requirements for 12-month follow up

Burnham RS and Yasui Y. Reg Anesth Pain Med 2007; 32:12-19

08/19/15 28

Bipolar disadvantage?

• Tissue along the sacrum is inhomogeneous- dense fibrous tissue, (ligament, fascia), muscle, fat etc.

• Different tissues respond differently to RF energy.

• One type of tissue may heat up quickly, while another will require more power to reach temperature

• Can cooled RF be better, because generator controls the rate of cooling to each probe, thereby regulating temperature independent of energy delivered.

Physics of Cooled RF

Modified from 8. Goldberg SN, Gazelle GS, Mueller PR.. AJR Am J Roentgenol 2000;174:323-31.


Modified from 8. Goldberg SN, Gazelle GS, Mueller PR.. AJR Am J Roentgenol 2000;174:323-31.


• Internal cooling and a small active tip size act to project the lesion distally in a controlled manner

• Uniform lesions can be produced in non-homogeneous tissue (e.g. into grooves, ligaments, fascia)

Standard 18G cannula

18 g cooled probe

Sacroiliac RF Lesion Requirements

• Level L5– Lesion the primary dorsal

ramus at sacral ala

• Level S1, S2, S3– Lesion all lateral branches as

they exit foramen

Procedure

•C-arm to visualize AP Sacrum (adequate cranial tilt to open L5S1)•Local/IV sedation. No GA. Optional Bowel prep

2:30lesion

4:00lesion

5:30lesion

Repeat2:30, 4 and5:30 lesionsAt S2

2:30 and4:00 lesionsAt S3

Procedure

•Place RF probe through introducer (extends 4 mm beyond tip of introducer = 2 mm off bone)

•Lateral fluoroscopy to assure not in canal

•Verify impedance 100 - 500 ohms

Sinergy Clinical Outcome Data

• Report of preliminary trial – Kapural (Pain Practice 2008)

• RCT Cohen (Anesthesiology 2008)

• RCT Patel & Gross (Pain Medicine 2012)

• Clinical case series – Stelzer (ESRA 2011)• Kapural L., Nageeb F., Kapural M., Cata J., Narouze S., Mekhail N., Cooled Radiofrequency System

for the Treatment of Chronic Pain from Sacroiliitis. Pain Practice (2008) 8;5:348-354.

• Cohen SP, Dragovich A, Hurley RW, Buckenmaier CC, Morlando B, Kurihara C. Randomized Placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology 2008; 109(2): 279–88.

• Patel N, Gross J, Brown L, Gehkt G. A double blind, randomized, placebo-controlled trial of lateral branch denervation as a treatment for sacroiliac joint pain using Sinergy system. Pain Medicine 2012 (online preview).

• Stelzer W., Wagner H, Aiglesberger M, Stelzer D, Stelzer V. Use of Cooled Radiofrequency Lateral Branch Neurotomy for the treatment of Sacroiliac Joint Mediated Low Back Pain: A Large Case Series. ESRA. September 2011 (Dresden, Germany).

Our data (Kapural et al., 2008)

Cohen Results

Percentage of Patients with Positive Outcomes: Reduction in Pain Severity, Pain Related Disabiltiy and Opiod Use

0 %0 %

14 %

57 %64 %

79 %

0

10

20

30

40

50

60

70

80

90

100

1 month 3 month 6 month

Post Procedure Follow-up

% P

ati

en

ts

Sham

Cooled-RF

• 79%, 64%, and 57% of treated patients experienced statistically significant positive outcomes at 1, 3 and 6 month post procedure, respectively.

Cohen ResultsMean Pain Severity: Visual Analogue Scale (VAS)

*0

1

2

3

4

5

6

7

8

9

10

baseline 1 month 3 months 6 months

Post Procedure Follow-up

VA

S Sham

Cooled-RF

• Mean pain severity as measured by the VAS showed a clinically meaningful improvement‡ at 6 months follow-up (6 to 2.6 points) for the Cooled-RF group

• The sham group did not show an improvement from baseline in VAS at 3 month follow-up (6.4 to 6 points)

Lateral Branch Denervation vs. Sham

• Patients randomized 2:1 to treatment and sham groups*

• Patient and assessors blinded

– Equipment sounds, procedure duration and visual indications identical in both groups

• Study outcomes: NRS, ODI, SF-36, GPE

• Treatment Success: – ≥50% decrease is VAS

corroborated by one of: i) 10-point improvement in ODI, or ii) 10-point improvement in SF-36BP

Treatment Group (n=34)

Sham Group(n=17)

Cross-Over Group

Unblinding

*12 month data currently being collected

Treatment Success

Time-Point Group

Treatment (n=30)

Sham (n=12)

p-value

3-Months 50% (31-69%) 8% (0-38%) .012

6-Months 40% (23-59%) ---

9-Months 60% (41-77%) ---

- A significantly greater proportion of subjects in the treatment group (50%; 95%CI 31-69%) as compared to the sham group (8%; 95%CI 0-38%) had a successful treatment outcome at 3-months (p=0.012)* - Treatment success rate was durable at 6-months and 9-months Treatment Success defined as: ≥50% decrease is VAS corroborated by one of: i) 10-point improvement in ODI, or ii) 10-point improvement in SF-36BP•Patel N, Gross J, Brown L, Gehkt G. A double blind, randomized, placebo-controlled trial of lateral branch denervation as a treatment for sacroiliac joint pain using Sinergy system. Pain Medicine 2012 (online preview).

SF-36PF

Outcome Measure Mean SD Mean SD p Value*

SF-36 Physical Functioning (0-100)

Treatment (n=27)

Sham (n=11)

3-months change 17 19 2 11 .020

6-months change 16 21 --- --- ---

9-months change 21 20 --- --- ---

- A significantly greater improvement in SF-36PF seen in treatment group (17±19) compared to sham (2±11) at 3-months follow-up (p = 0.020)

-Mean treatment SF-36PF score was durable at 6-months and 9-months

•Patel N, Gross J, Brown L, Gehkt G. A double blind, randomized, placebo-controlled trial of lateral branch denervation as a treatment for sacroiliac joint pain using Sinergy system. Pain Medicine 2012 (online preview).

ODI

Outcome Measure Mean SD Mean SD p Value*

Oswestry Disability Scale (0-100)

Treatment (n=27)

Sham (n=10)

3-months change -12 18 0 7 .034

6-months change -14 17 --- --- ---

9-months change -16 18 --- --- ---

- A significantly greater improvement in ODI seen in treatment group (-12±18) as compared to the sham group (0±7) at 3-months follow-up (p = 0.034)-Mean treatment ODI score was durable at 6-months and 9-months

•Patel N, Gross J, Brown L, Gehkt G. A double blind, randomized, placebo-controlled trial of lateral branch denervation as a treatment for sacroiliac joint pain using Sinergy system. Pain Medicine 2012 (online preview).

Stelzer Clinical Series

• Retrospective chart review

• n=126

• Inclusion criteria

• Outcome measures: VAS, QOL, medication usage

Steltzer: Sinergy Clinical Series

DR L5; Kapural et al; Pain Medicine 2010

Kapural L, Sessler DI, Stojanovic PM, Bensitel T, Zovkic P. Cooled Radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Medicine 2010;11(1):53-57.

Max. Insertion depthL5/S1 z-joint space

Probe is 2mm off bone for distal lesion projection

DR L5 • Kapural et al, Pain Medicine, 2010

Summary

• SIJ Radiofrequency provides for anatomic RF lesioning of the dorsal innervation of the SIJ

• No significant complications from various approaches reported to date

• Efficacy and duration of Synergy effect demonstrated in two RCT’s.

Intradiscal Biacuplasty-Technique and Data

Leonardo Kapural, MD, PhDCarolinas Pain Institute and Center for Clinical ResearchProfessor of Anesthesiology, Wake Forest University School of Medicine

Possible Scenario

Loss of Nuclear Hydrostatic Pressure

Delamination FissuringMicrofracutures

of collagen fibrils

Sensitization of Nonciceptors

PLA2, NO, IL1Repetitive stimulation

of DRG

Saal and Saal,2002; Ozaktay et al., 1998; Schwartzer et al., 1995

Possible algorithm (Kapural and Deer, 2011)

Kapural L, Deer T. Radiofrequency and other heat applications for the treatment of discogenic pain. Eds. Kapural L, Kim P. Diagnosis, Management and Treatment of Discogenic Pain. Interventional and Neuromodulatory Techniques for Pain Management Series Vol3. Elsevier, Philadelphia, PA 2011, pp 80-87

Provocative discography

• To date, provocation discography is the only available method of linking the morphologic abnormalities seen on MRI with clinically observed pain…..

• Kapural L. Lumbosacral internal disc disruption syndrome: Therapeutic intradiscal procedures. Interventional Spine Care, ed. Brian De Palma, 2010

• Radiofrequency current is concentrated between electrodes on two straight probes.

• The electrodes are internally cooled allowing deep, even heating and eliminating tissue adherence.

• Temperature sensors allow monitoring at the electrode tips and disc periphery.

• The ideal temperature profile is 55-60°C in the inner posterior disc decreasing to 45°C in the peripheral edge of the posterior disc.

Biacuplasty

Temperatures monitoring at designated safety zones outside the disc demonstrated maintenance of near-physiologic conditions while temperature across the posterior annuls reached 65°C

Petersohn J et al. 2008 Pain Medicine (9): 26-32

In vivo Testing in Porcine Model

Biacuplasty study using explanted human lumbar spines.

Cadaver Study

Kapural et al. 2008 Pain Medicine (9): 68-75

Cadaver Study



TransDiscal System During Procedure

Acceptable angle

• Approach Angle is adjusted to 45° from the median

• Increased approach angle brings probes close enough to create a confluent lesion

• Set temperature is adjusted to 50 °C

• Following the bipolar lesion, monopolar lesions are created around each electrode to lesion the posterior-lateral aspect of each disc.

75

• 45° approach angle

45°

<3cm

StatisticsMedian [Quartiles]

Outcome Baseline 12 Month Difference† % Difference† P-Value*

SF-36 Bodily Pain 35 [33, 45] 58 [45, 78] 10 [13, 35] 37 [15, 78] 0.016

SF-36 Physical Functioning 55 [40, 60] 75 [50, 95] 10 [-5, 35] 17 [-6, 73] 0.09

Oswestry Score 25 [17, 29] 17 [10, 24] -4 [-9, 1] -13 [-64, 6] 0.07

VAS Pain Score 7 [ 6, 8] 4 [ 1, 6] -4 [-5, -1] -44 [-86, -14] 0.003

Opioid Use 40 [40, 120] 0 [ 0, 20] -40 [-50, -20] -100 [-100, -62] < 0.001

† Differences from baseline to 12 months.

* Wilcoxon signed rank test of percent difference equal to 0.

Kapural L. Intervertebral Disc Cooled Bipolar Radiofrequency (Intradiscal Biacuplasty) for the Treatment of Lumbar Discogenic Pain: a 12 month follow-up of the pilot study. Pain Medicine 2008;8(4):464.

Randomized Control Trial (Kapural et al, 2013)

1830 Excluded1771 Did not meet clinical inclusion criteria36 Skipped enrollment appointment23 Declined to be randomized or comply with protocol

Treatment Group

Sham Group

Unblinding

6 month follow-up (n=28)

64 Enrolled




3 subjects chose not to receive active treatment



2 subjects censored from analysis:1 early drop out (no follow-up data obtained)1 breach of eligibility criteria

2 dropped-out (included in analysis)

30 received sham treatment29 received IDB

25 subjects received active treatment

32 Allocated to receive IDB

32 Allocated to receive sham

2 Excluded before treatment:2 breached eligibility criteria

1894 Inquiries

3 Excluded before treatment:1 declined to undergo procedure2 breached eligibility criteria

Kapural, L., Vrooman, B., Sarwar, S., Krizanac-Bengez, L., Rauck, R., Gilmore, C., North, J., Girgis, G. and Mekhail, N. (2012), A Randomized, Placebo-Controlled Trial of Transdiscal Radiofrequency, Biacuplasty for Treatment of Discogenic Lower Back Pain. Pain Medicine. doi: 10.1111/pme.12023

IDB Sham

Outcome Measure Mean SD Mean SD p Value

SF-36 Physical Functioning (0-100) n=27 n=30

Baseline 47.04 20.30 46.03 19.30 .849

1-month 50.68 20.03 46.61 20.60 .458

3-months 57.17 20.32 48.00 22.95 .118

6-months 62.04 21.89 48.67 22.97 .029

NRS for pain (0-10) n=27 n=29

Baseline 7.13 1.61 7.18 1.98 .912

1-month 5.31 2.04 5.72 2.29 .486

3-months 4.94 2.05 5.98 2.36 .083

6-months 4.94 2.15 6.58 2.11 .006

Oswestry Disability Scale (0-100) n=27 n=30

Baseline 40.37 12.30 40.93 13.56 .871

1-month 40.85 13.36 39.85 17.03 .807

3-months 37.43 16.65 40.44 16.21 .493

6-months 32.94 16.14 41.17 13.94 .037

1 level (n=16) 2 levels (n=11)

Outcome Measure Mean SD Mean SD p Value

SF-36 Physical Functioning (0-100)

Baseline 48.75 17.08 44.55 24.95 0.607

6-months 66.88 18.34 55.00 25.50 0.171

6-months change 18.13 15.37 10.45 18.23 0.248

NRS for pain (0-10)

Baseline 7.47 1.45 6.64 1.76 0.191

6-months 4.69 2.38 5.32 1.81 0.465

6-months change -2.78 2.59 -1.32 1.95 0.126

Oswestry Disability Scale (0-100)

Baseline 38.88 8.48 42.55 16.64 0.457

6-months 28.88 13.04 38.85 18.90 0.116

6-months change -10.00 8.91 -3.70 10.99 0.113

Kapural, L., Vrooman, B., Sarwar, S., Krizanac-Bengez, L., Rauck, R., Gilmore, C., North, J., Girgis, G. and Mekhail, N. (2012), A Randomized, Placebo-Controlled Trial of Transdiscal Radiofrequency, Biacuplasty for Treatment of Discogenic Lower Back Pain. Pain Medicine. doi: 10.1111/pme.12023

Treatment patientsSF (PF) and NRS at all time points (Kapural et al, in preparation)

Per protocol Mean PF ∆ PF

Mean SD ∆ SD

Baseline (n=27) 47.04 20.30

1 month (n=26) 50.68 20.03 2.99 21.43

3 month (n=26) 58.27 19.90 11.57 15.35

6 month (n=27) 62.04 21.89 15.00 16.70

9 month (n=22) 64.55 23.45 17.27 18.43

12 month (n=22) 68.86 19.33 21.59 20.26

Per protocol Mean NRS ∆ NRS

Mean SD ∆ SD

Baseline (n=27) 7.13 1.61

1 month (n=26) 5.31 2.04 -1.79 2.44

3 month (n=24) 5.06 2.01 -1.98 2.16

6 month (n=25) 4.90 2.23 -2.18 2.47

9 month (n=22) 4.59 2.28 -2.70 2.49

12 month (n=22) 4.40 2.56 -2.90 2.56

Treatment patients ODI and Opioids at all time points (Kapural et al, in preparation)

Per protocol Mean ODI ∆ ODI

Mean SD ∆ SD

Baseline (n=27) 40.37 12.30

1 month (n=27) 40.85 13.36 0.48 10.19

3 month (n=26) 36.41 16.10 -3.74 10.89

6 month (n=27) 32.94 16.14 -7.43 10.11

9 month (n=22) 31.81 15.66 -7.65 9.93

12 month (n=22) 32.44 16.13 -7.01 10.92

Per protocol Mean Opioids ∆ Opioids

Mean SD ∆ SD

Baseline (n=27) 52.47 49.581 month (n=27) 47.94 46.86 -4.54 32.143 month (n=27) 44.65 47.21 -7.82 34.056 month (n=27) 36.87 40.56 -15.60 46.759 month (n=20) 26.80 35.28 -20.10 47.0612 month (n=17) 34.07 47.44 -15.37 54.46

Summary

•Biacuplasty is an effective minimally invasive alternative for treatment of lumbar discogenic back pain

•Strict selection criteria improves results of biacuplasty

•Postprocedurally an optimal rehabilitation step-by-step program is required to ascertain a good outcome

•Patients with increased body mass index, a smoking habit, and multilevel degenerative disk disease have less chance to improve long term

•Based on currently available data, such minimally invasive approach more efficacious than any surgery

Thank youThank [email protected]@ccrpain.com

Treatment of Chronic Thoracic Facet Pain

Prevalence

• The z-joint may be a source of pain in 34-48% of patients with chronic thoracic pain

• “Pain in the thoracic region is a common complaint which can be as disabling as cervical or lumbar pain.” (Edmondson and Singer, 1997)

Manchikanti et al. Pain Physician 2002;5:354-359Manchikanti et al. BMC Musculoskelet Disord 2004;5:15Manchukonda et al. J Spinal Disord Tech 2007; 20:539-545Edmondson SJ, Singer KP. Man Ther 1997; 2:132-143.

Dorsal Rami in Transverse Space

• Initially, each dorsal ramus passes through an osseofibrous canal, and dorsally to enter the transverse space.

• Within intertransverse space, dorsal ramus travels 1-2 mm before dividing into lateral and medial branches. Posterior right

Transverse Process

Medial Branch

Thoracic Dorsal Ramus Lateral Branch

Transverse Process

Adapted from Fig 2.8 of Chua Thesis 1994

Medial Branches of Dorsal Rami

• The medial branch innervates:

-Z-joint joint

-Multifidus

-Spinalis thoracis, splenius cervicis, rhomboids and trapezius (upper levels only)

• The medial branch follows a general path which displays certain level of variability between individuals, and between different levels in the same individual

Variations in MB Path

• There are many variations of the general path for the thoracic medial branch.

- Variations observed in individuals between different levels, and sides.

- Variations also observed between individuals.

- Regions display a distinct MB innervation pattern:

• T1-T4, T9-T10 • T5 -T8• T11

Fig 2.18 of Chua Thesis 1994

Significant overlap exists between thoracic segmental pain referral patterns Significant overlap exists between thoracic segmental pain referral patterns

Adapted from Dreyfuss et al., Spine 1994;19(7):807-11 (Fig.3) and Fukui et al., Reg Anesth 1997;22(4):332-6 (Fig.1,2).

Thoracic Zygapophysial Pain Pattern

Study Method Patients Result

Tzaan and TaskerCan. J. Neuro. Sci. 2000, 27(2): 125-30

Retrospective: 1983-1994

Medial branch RF neurotomy, including thoracic

118 procedures; 90 patients

Diagnosis: local anesthetic block (>50% pain reduction)

40% had >50% pain relief

Mean follow-up 5.6 months

Stolker et al.Acta Neurochir (Wien) 1993, 122: 82-90

Retrospective

Thoracic RF neurotomy

40 patients

Diagnosis: medial branch block (>50% pain reduction)

83% had >50% pain relief

36 month follow-up

Treatment with Conventional RF

• Level of evidence supporting thoracic RF neurotomy is inconclusive

- Conventional RF lesion size is not adequate to encompass the variability of the thoracic medial branch nerve path

• Local anesthetic injections provided to patients in absence of a more effective option

- Medial branch blocks with long acting local anesthetic effective for 15-17 weeks (Manchikanti et al. Pain Physician. 2008;11(4):491-504)

Current Treatment

Step 1: Position C-arm in AP; locate treatment level

AP View

Costotranverse joint lucency to the right of the needle

Oblique View

Step 2: Rotate C-arm ipsilateral oblique until the costotransverse joint lucency comes into view

Skin insertion

point

Oblique View

Step 3: Insert Introducer at inferolateral aspect of costotransverse joint lucency level

Land on bone at superomedial aspect of joint

lucency

target

insertion

Oblique View

Step 4: Advance Introducer to superomedial aspect of costotransverse joint lucency

Oblique View

Step 5: Position C-arm in AP and walk stylet up to superior margin of transverse process

Ensure radiopaque marker is at superior margin of transverse process

Oblique View

Step 6: Replace stylet with probe

Lateral View

Step 7: Confirm depth on lateral

Step 9: Create Cooled RF lesion

AP View

Set Temp = 60°C

Duration = 2:30 min

Ramp = 80°C/min

• Lateral to medial approach directs introducer tip towards vertebral body

• Ipsilateral oblique placement constrains lesion to superolateral aspect of transverse process

• Straightforward imaging aids in identifying transverse process

• Large, spherical lesion targets variability of nerve path

• One introducer insertion reduces iatrogenic injury to the patient

Procedure Summary

Study of temperature distribution of a novel mono-polar cooled-radiofrequency heating system in human cadaver applied to the

thoracic medial branches of a human cadaver

N. Mekhail, M.D. Ph. D.; J. Cheng, M.D. Ph. D. Pending Publication

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Neuroablative temperatures measured at 5 mm radius.

Cadaveric Temperature Study - Results

Description of a novel device, novel technique, in vivo temperature study, and 8 patient 6-month outcomes

R. E. Wright, S. Brandt, K. Allen, J. Wolfson. Pending Publication

Temperature in vivo

Distance from Electrode (mm)

Temperature (°C)

3 714 575 556 478 39

23 37

• Neuroablative temperatures are reached in the intertransverse space 6 mm from electrode (Smith, 1981)

• The zone of ablation measured spans 58% of the intertransverse space

• This zone encompasses the volume of tissue through which the medial branch is known to travel

Smith HP et al. J Neurosurg. 1981;55(2):246-53

Six-Month Average VAS Pain Score

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• 7/8 (88%) >50% pain relief

• 4/8 (50%) >10 pt or >50% drop in ODI

• 8/8 (100%) >10 pt improvement in SF-36 BP

• 6/8 (75%) >10 pt drop in SF-36 PF

• 3/8 (38%) Meds reduced

• 8/8 (100%) Satisfied (positive GPE)

Prospective Trial: 6-month outcomes

Safety

•Survey of anatomy shows no sensitive structures within target area.

•Advancing introducer towards Thoracic Safe Zone mitigates risk of pleural puncture.

•Obtaining both AP and lateral views confirms location of the introducer tip.

Efficacy

• Large, spherical, Cooled-RF lesion increases probability of successful medial branch ablation even with variability in nerve path.

• Placement on bony landmark (transverse process) provides repeatability for procedure.

ThoraCool Advantage

New and upcoming Coolief Treatments

• Hip denervaton

• Knee denervation

Application to Hip Pain

Frequent causes of hip pain:

•DJD

•AVN

•Labral tears

•FAI

•Tumor

Innervation of the hip joint is regionally specific:• Anteromedial innervation supplied by the articular branches of the

obturator nerve or accessory obturator nerve

• Anterior hip joint capsule innervated by sensory articular branches of the femoral nerve

• Posterior innervation supplied by articular branches derived from the sciatic nerve

–Posteromedial hip joint capsule innervated by articular branches from the nerves to the quadratus femoris muscle

–Posterolateral hip joint capsule innervated by articular branches from the superior gluteal nerve.

Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint – An anatomical study. Surg Radiol Anat (1997)19; 371-375.

Neuroanatomy of the anterior hip joint

YESLocher, S et. Al. Radiologic anatomy of the obturator nerve and its articular branches: Basis to develop a method of radiofrequency denervation for hip joint pain. Pain Med 9(3) 2008;291-298.

Does RF lesioning of articular branches succeed in relieving hip pain?

New 2014 data on anatomic variants

• Dissected 7 cadaveric hip joints

• Accessory obturator nerve variant (blue)

• Obturator articular branch variant (red) as seen by Locher.

Franco CD, RD Menzies, JD Petersohn, A Buvanendran , LP Menzies – manuscript in preparation 2014

Femoral articular branch innervation

• Innervation to the anterosuperior aspect of the hip is relatively constant across the 11:30-12:30 clock position.

• Two femoral articular branches shown derived from nerve to iliacus mm.

• Hypothetical RF lesions made with Coolief™ RF probe at 12 o’clock position shown in gold.

Variation of obturator nerve innervation pattern

• The paths of the obturator articular branch(es) vary across the ischium – Two vertically adjacent lesions are made with Coolief™ RF probe over the ischium for reliable denervation.

• An additional RF lesion shown may be required to address documented anatomic variation (noted during diagnostic block) where additional innervation to anterior hip is provided by an accessory obturator nerve.

Peripheral RF for Knee Pain

The knee joint is innervated by the articular branches of various nerves, including the femoral, common peroneal, saphenous, tibial and obturator nerves.Hirasawa Y, et al. Nerve Distribution to the human knee joint: anatomical and immunohistochemical study. Int Orthop 2000; 24:1-4.

The cutaneous and articular sensory innervation of the knee region is complex and displays considerable variation.Lund J, et al. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand 2011; 55: 14-19

25 ga stainless steel wires outline course of geniculate

nerves

Franco CD, RD Menzies, JD Petersohn, A Buvanendran, LP Menzies – Manuscript in preparation 2014

• Supine position with ipsilateral knee elevated using towels. Sterile prep and drape with strict aseptic technique.

• True AP image of distal femur. Identify 2 target sites:• Superior lateral geniculate nerve where the lateral

femoral shaft meets the epicondyle• Superior medial geniculate nerve where the medial

femoral shaft meets the epicondyle• Anesthetize skin and soft tissues with 1% Lidocaine.

At each target, advance 25 gauge needle using “tunnel technique” until bony contact is made.

• Repeat using true AP image for proximal tibia. Identify target for inferior medial geniculate nerve where the medial tibial shaft meets the epicondyle using technique above.

Geniculate Branch Diagnostic Block Technique

Optional lesion for the nerve from the rectus intermedius supplying the subpatellar plexus. • DO NOT block the inferior lateral geniculate

nerve! Lesioning this nerve will injure the adjacent common peroneal nerve.

• Adjust c-arm fluoroscopy for lateral image• Adjust needle tip to be half-way across diaphysis

before injecting 0.5-1.0 ml local anesthetic at each site. Target is Midline femur about 2 cm cephalad of the upper patellar border

Geniculate Branch Diagnostic Block Technique

Final probe positioning for RF geniculate neurotomy

Coolief™ RF treatment for post-prosthetic knee pain

Thank youThank [email protected]@ccrpain.com

lorangerie 23 10 12 00 leonardo kapural (simposio optika).ppt

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