Ghazi_Neuromodulation

8/7/2019 Ghazi_Neuromodulation

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Evidence Based for FailedBack Syndrome

Chair, Department of Pain Medicine,Mayo Clinic Florida

Assistant Professor, Department of

Anesthesia, Mayo Clinic Florida Co-Chair, Essential Tools AAPM

Interests: International Chronic Pain

Management

SCS Intrathecal Pump RFD, Cooled RFD, Pulsed RF Cancer Pain

Contact:[email protected]

Salim M. Ghazi, MD


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NEUROMODULATION EVIDENCEIN NEUROPATHIC PAIN

SALIM M GHAZI MD

S.P.I.N.E

BEIRUT 2010


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Orlando

JacksonvilleOrlando toJacksonville140 miles


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DISCLOSURES

FinancialDisclosures

NONE

Off-LabelDiscussion

1.Use of spinal

stimulation electrodesand generators forperipheral nervestimulation

2. Spinal stimulationsystems for visceralpain, ischemic pain,and miscellaneouspain syndromes


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Pain Definitions The IASP defines pain as an unpleasant

sensory and emotional experience associatedwith actual or perceived tissue damage ordescribed in terms of such damage1

Pain can be classified according to primaryetiology2

Neuropathic Nociceptive Mixed neuropathic and nociceptive

All types of pain can also be classified byduration3

Acute: less than 6 weeks Sub-acute: between 6 weeks and 3 months Chronic: lasting > 3-6 months

1 Merskey H, Bogduk N, eds. Classification of Chronic Pain, 2nd Ed. IASP Press Seattle, 19942 Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-3743 Koes BW, et al. Br Med J. 2006;332:1430-1434


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What is Neuropathic Pain?

The International Association for the Study of Pain(IASP) definition of neuropathic pain:

Pain initiated or caused by a primary lesion ordysfunction in the peripheral or central nervous system.

Neuropathic pain must involve the somatosensorypathways with damage to small fibers in peripheral

nerves or to the spino-thalamo-cortical system inthe central nervous system.


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What is neuropathic Pain?

Caused by damage to the nervous system

Described as burning, shooting or tingling sensations

A common problem with an estimated prevalence of 1.5%1

Causes major disability and significantly reduces quality of life2,3

The burden on patients and healthcare systems is substantial1

Patients consume a high level of healthcare resources1

Associated with a 3-fold increase in healthcare costs4

1. Taylor RS. Pain Practice 2006

2. Meyer-Rosberg K, et al. Eur J Pain 2001

3. Kemler MA, et al. New Eng J Med 2000

4. Berger A, et al. J Pain 2004


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Types of Neuropathic Pain Direct nerve root injury: radiculopathy

Battered root syndrome

Perineural fibrosis Intrafascicular fibrosis Adhesive arachnoiditis

Peripheral deafferentation

Phantom limb pain Sympathetic-mediated pain syndrome Herpetic neuralgia Diabetic polyneuropathy

Central deafferentation-thalamic strokeCole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374


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Actual treatment of NP

Pharmacotherapy is currently the mainstay of treatment and isroutinely used in all patients with neuropathic pain

However, not all drugs are suitable for all patients at all stages of their

disease

Less than 50% of patients achieve greater than 50% relief ofneuropathic pain with pharmacotherapy

6,7

Many patients experience intolerable side effects (eg: sedation, cognitive

impairment, somnolence, nausea, constipation)

One-third of patients with chronic pain are currently not being

treated at all5

5. Breivik H, et al. Eur J Pain 2006

6. Eisenberg E. JAMA 2005

7. Finnerup NB et al. Pain 2005


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Pharmacologic Management of Neuropathic Pain

Pain 2007;132:237-251


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Pharmacologic Management of Neuropathic Pain:Evidence-based Recommendations

Pain 2007;132:237-251

Conclusion: Existing pharmacologictreatments for NP pain are limited, withno more than 40-60% of patients

obtaining partial relief of their pain.


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NEUROMODULATION

ELECTRICAL = NEUROSTIMULATION

CHEMICAL: INTRATHECAL DRUG

DELIVERY OPIOIDS NON-OPIOIDS


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Spinal Cord Stimulation

Introduced in the late 1960s by Melzack and Wall

What is Neurostimulation?

A technique that alleviates pain by sendingelectrical impulses via implanted leads tothe spinal cord The impulses activate pain-inhibiting neuronal

circuits in the dorsal horn and induce a tinglingsensation (paresthesiae) that masks the

sensations of pain

What is the goal of Neurostimulation? To obtain more than 80% coverage of the

painful areas with paresthesiae, so that atleast a 50% reduction in pain can bemaintained at one year follow-up


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Gate Control Theory

When sensory impulses are greater than painimpulses

Gate in the spinal cord closes preventing the pain

signal from reaching the brain

C FIBER

PROJECTIONNEURON

AaAb FIBERS

INHIBITORYINTERNEURON

Pain

Sensory

Gate


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Gate Theory and SCS

SCS system implanted near dorsal columnstimulates the pain-inhibiting nerve fibers maskingpainful sensation with a tingling sensation(paresthesia)

C FIBER

PROJECTIONNEURON

AaAb FIBERS

INHIBITORYINTERNEURON

Pain

Sensory

Gate

SCS

Hi f N i l i


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History of Neurostimulation 1967-1ST Technical report for back/limb pain

1970s-Equipment limitations/ open surgery

1975-76-percutaneous technique introduced

1980s-Equipment advances-mainstream therapy(Medtronic)

1987-First SCS trial for angina

1990s-Three major vendors

1990s-Multiple leads/multipleprograms/expanded indications.

20,000-30,000 pts/yr worldwide.


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Pain Indications for Stimulation

Intractable neuropathic pain

Any body region: Head-to-Toe

Properly screened patient


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Outcomes of SCS

In the treatment of neuropathic pain:

Pharmacological management: 50% ofpatients achieve adequate pain relief

SCS: 65% of medically refractory patientsachieve at least 50% pain relief sustainedlong-term 1

1 Taylor et al (2005)

27


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Neurostimulation: Reduction in Pain

Reference # of Patients Mean

Follow up

Results

North

Pain, 1993

171 7 years 52% with > 50% relief

Turner

Neurosurgery, 1995

39 study meta analysis 16 months 59% with > 50% relief

De la Porte

Pain, 1993

64 4 years 55% good to excellentrelief

Segal

Neurol Research, 1991

24 19 months 78% good to very goodeffect

Kumar

Surg Neurol, 1991

111 5.6 years 59% good to excellentresults

Burchiel

Spine, 1996

70 Multi-center 1 year 55% with > 50% relief


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Reduction in Analgesic Consumption

Ohnmeiss 40 2 years 66% decreased eliminated

Spine, 1996 narcotics

North 171 7 years 58% reduced/eliminated

Neurosurgery, 1995 analgesics

De La Porte 64 4 years 90% reduced medication

Pain, 1993

Kumar 111 5.6 years 59% satisfactory relief

Surg Neurol, 1991

Racz 26 1.8 years 81% reduced/eliminated

Spine, 1989 narcotics

Segal 24 19 months 59% satisfactory relief

Reference# of

PatientsMean

Follow-up Results

T t t f Ch i P i ith S i l C d Sti l ti


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Treatment of Chronic Pain with Spinal Cord Stimulationversus Alternative Therapies: Cost-effectiveness

Analysis.

CONCLUSION:

SCS is cost-effective in the long term, despite theinitial high costs of the implantable devices.

Kumar, Krishna F.R.C.S.(C), F.A.C.S.; Malik, Samaad M.D., B.Sc.; Demeria,Denny M.D. July 2002


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SCS for Chronic Pain-22 Year Experience

452 patients treated with SCS over 22 yrs

220 patients with FBSS

-Mean f/u duration-97 months

-f/u by disinterested 3

rd

party 132/220 pts. with greater than 50% pain relief

(65%)

Other notables:

-9/9 angina patients had relief

-4/19 PHN patients had relief

Kumar, et al. Neurosurgery 2006;58:481-496


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SCS vs Repeat Surgery for Chronic Back Pain

45 patients w persistent pain after L-spine

Surgery RCT w crossover

Success: >50% pain relief, patient satisfaction,

crossover 9/19 SCS vs 3/26 Surgery successful outcome

(p


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Spinal Stimulation (SCS) vs Conventional Medical Management(CMM) for Neuropathic Painin Patients with Failed Back surgery

Syndrome

RCT-100 patients w FBSS (neuropathic radicular pain)

SCS+CMM vs CMM

48% of SCS and 4% of CMM achieved primaryoutcome of > 50% pain relief

SCS group also had

-improved Q.O.L.

-improved functional measures

-greater treatment satisfaction

Kumar K. et al. Pain 2007;132:179-188


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Spine Surgery and Post Procedure Pain

Incidence of persistent or recurrent pain afterlumbar surgery-10-40%

Success rate of 2nd operation is 10-30%

Fusion/Instrumentation-Increased frequencyof FBSS ( Donor site 15%, pseudoarthrosis15%, instrument failure 7%, nerve injury 3%,etc)

Surgery/Fusion rate has increased by nearly100% since 1996. >500,000 per year.

Deyo, et al. NEJM 350:722-726,2004

North, et al. Neurosurgery 56:89-107;2005


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SCS for Angina/Chest painRandomized Trial-104 patients, SCS vs CABG


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SCS in Severe Angina Pectoris-A Systematic ReviewBorjesson M, et al. Pain 2008;140:501-508

Evaluated 43 Clinical Trials 8 medium to high quality studies

Strong Evidence that SCS gives rise to

symptomatic benefits-decreased anginal attacks

-decreased NTG, analgesic use

Strong evidence that SCS can improve thefunctional status of these patients

-improved exercise treadmill time

-increased walking distance w/o angina


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PNS for Neuropathic Pain-Outcomes

6 clinical trials, 202 patients (no RCTs)

Average success rate-60% of patientswith greater than 50% improvement

Cruccu G, et al. Guideline on NeurostimulationTherapy for Neuropathic Pain. Eur J Neurol2007;14:952-970


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MOTOR CORTEX STIMULATION

Results 90% effective for neuropathic

trigeminal pain, anesthesiadolorosa, and ophthalmic post-herpetic neuralgia

75% excellent results for thalamicpain

Mayo Clinic experience 22 patients


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MCS-Indications and Outcomes

Indications-Post-stroke pain (thalamic pain)

-anesthesia dolorosa (surgery, trauma)

-postherpetic neuralgia

Results

-No large scale series and/or RCTs-multiple clinical series since 1993: 40-75% of patients with

> 50% pain relief

-Largest series;29/38(76%) of patients improved

Neurosurgical Focus 2006;21:1-4


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Indications for Neurostimulation andIntrathecal Drug Delivery Therapy

Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362. Refer to full prescribing information for MedtronicNeurostimulation Systems and Synchromed II and Isomed Drug Infusion Systems


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CONCLUSION

NEUROPATHIC PAIN IS DIFFICULTTO TREAT

MULTIDISCIPLINARY APPROACHNEEDED

CONSERVATIOVE APPROACH

SHOULD BE INITIATED FIRST: MEDICATIONS APPROPRIATE PT

INJECTIONS


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AND IF NOT HELPFUL OR SHORT-LIVED:

NEURO-STIMULATION


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QUESTIONS?

[email protected]


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14. Struijk JJ, Holsheimer J, Spincemaille GHJ, Gielen FLH, Hoekema R.Theoretical performance and clinical evaluation of transverse tripolar spinalcord stimulation. IEEE Trans Rehabil Eng 1998;6(3):27785

15. Taylor RS, Taylor RJ, Van Buyten J-P, et al. The cost effectiveness of spinal

cord stimulation in the treatment of pain: A systematic review of the literature. JPain Symptom Manage 2004;27:3708.

16. Yearwood TL. Tripolar neurostimulator array in the cervical epidural space forthe treatment of bilateral lower extremity pain [Abstract]. Neuromodulation2006;9(1):189.

17. SCS for Non-reconstructable Chronic Critical Leg Ischemia- SCS vs Standard

Conservative TreatmentCochrane Database of Systematic Reviews, (Feb 2008)

18. Ambrosini, A. (2007). "Occipital nerve stimulation for intractable clusterheadache." Lancet 369(9567): 1063-5.

19. Amin, S., A. Buvanendran, et al. (2008). "Peripheral nerve stimulator for thetreatment of supraorbital neuralgia: a retrospective case series." Cephalalgia

28(4): 355-9.20. Bartsch, T. and P. J. Goadsby (2002). "Stimulation of the greater occipital nerve

induces increased central excitability of dural afferent input." Brain 125(Pt 7):1496-509


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Bibliography

1. Bennett DS, Al KM, Oakley J, Feler CA. Spinal cord stimulation forComplex Regional Pain Syndrome I (RSD). A retrospective multicenterexperience from 19951998 of 101 patients. Neuromodulation1999;2(3):20210.

2. Burchiel KJ, Anderson VC, Brown FD, et al. Prospective, multicenter studyof spinal cord stimulation for relief of chronic back and extremity pain.

Spine 1996;21(23):278694.

3. Grabow TS, Tella PK, Raja SN. Spinal cord stimulation for complex regionalpain syndrome.

: An evidence-based medicine review of the literature. Clin J Pain2003;19(6):37183

4. Harke H, Gretenkort P, Ladleif HU, Koester P, Rahman S. Spinal cordstimulation in postherpetic neuralgia and in acute herpes zoster pain.Anesth Analg 2002;94(3):694700.

5. Holsheimer J, Khan YN, Raza SS, Khan EA. Effects of electrode positioningon perception threshold and paresthesia coverage in spinal cordstimulation. Neuromodulation 2007;10(1):3441.


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6. Holsheimer J, Wesselink WA. Optimum electrode geometry for spinal cordstimulation: The narrow bipole and tripole. Med Biol Eng Comput1997;35(5):4937

7. Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients

with chronic reflex sympathetic dystrophy. N Engl J Med 2000;343(9):61824.8. Kemler MA, De Vet HC, Barendse GA, Van Den Wildenberg FA, Van Kleef M. The

effect of spinal cord stimulation in patients with chronic reflex sympatheticdystrophy: Two years' follow-up of the randomized controlled trial. Ann Neurol2004;55(1):138.

9. Kim SH, Tasker RR, Oh MY. Spinal cord stimulation for nonspecific limb pain

versus neuropathic pain and spontaneous versus evoked pain. Neurosurgery2001;48(5):105664

10. Kumar K, Buchser E, Linderoth B, Meglio M, Van Buyten J-P. Avoidingcomplications from spinal cord stimulation: Practical recommendations from aninternational panel of experts. Neuromodulation 2007;10(1):2433.

11. Kumar K, Toth C, Nath RK. Spinal cord stimulation for chronic pain in

peripheral neuropathy. Surg Neurol 1996;46(4):3639.12. Oakley J, Varga C, Krames E, Bradley K. Real-time paresthesia steering using

continuous electric field adjustment. Part I: Intraoperative performance.Neuromodulation 2004;7(3):15767

13. Slavin KV, Burchiel KJ, Anderson VC, Cooke B. Efficacy of transverse tripolarstimulation for relief of chronic low back pain: Results of a single center.Stereotact Funct Neurosurg 1999;73(1-4):12630.


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21. Burns, B., L. Watkins, et al. (2007). "Treatment of medically intractable clusterheadache by occipital nerve stimulation: long-term follow-up of eight patients."Lancet 369(9567): 1099-106.

22. Busch, V., W. Jakob, et al. (2006). "Functional connectivity between trigeminal

and occipital nerves revealed by occipital nerve blockade and nociceptive blinkreflexes." Cephalalgia 26(1): 50-5.

23. Goadsby, P. J. (2007). "Neurostimulation in primary headache syndromes."Expert Rev Neurother 7(12): 1785-9.

24. Goadsby, P. J., T. Bartsch, et al. (2008). "Occipital nerve stimulation forheadache: mechanisms and efficacy." Headache 48(2): 313-8.

25. Leone, M., A. Franzini, et al. (2007). "Stimulation of occipital nerve for drug-resistant chronic cluster headache." Lancet Neurol 6(4): 289-91.

26. Magis, D., M. Allena, et al. (2007). "Occipital nerve stimulation for drug-resistantchronic cluster headache: a prospective pilot study." Lancet Neurol 6(4): 314-21.

27. Melvin, E. A., Jr., F. R. Jordan, et al. (2007). "Using peripheral stimulation to

reduce the pain of C2-mediated occipital headaches: a preliminary report." PainPhysician 10(3): 453-60.

28. Slavin, K. V., H. Nersesyan, et al. (2006). "Peripheral neurostimulation fortreatment of intractable occipital neuralgia." Neurosurgery 58(1): 112-9;discussion 112-9.


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29. Hornberger, J., K. Kumar, et al. (2008). "Rechargeable Spinal Cord StimulationVersus Nonrechargeable System for Patients With Failed Back SurgerySyndrome: A Cost-Consequences Analysis." Clin J Pain 24(3): 244-252.

30. Andrell, P., O. Ekre, et al. (2003). "Cost-effectiveness of spinal cord stimulation

versus coronary artery bypass grafting in patients with severe angina pectoris--long-term results from the ESBY study." Cardiology 99(1): 20-4.

31. Buchser, E., A. Durrer, et al. (2006). "Spinal cord stimulation for themanagement of refractory angina pectoris." J Pain Symptom Manage 31(4Suppl): S36-42.

32. Chua, R. and A. Keogh (2005). "Spinal cord stimulation significantly improvesrefractory angina pectoris-a local experience spinal cord stimulation inrefractory angina." Heart Lung Circ 14(1): 3-7.

33. Di Pede, F., G. A. Lanza, et al. (2003). "Immediate and long-term clinicaloutcome after spinal cord stimulation for refractory stable angina pectoris." AmJ Cardiol 91(8): 951-5.

34. Eddicks, S., K. Maier-Hauff, et al. (2007). "Thoracic spinal cord stimulationimproves functional status and relieves symptoms in patients with refractory

angina pectoris: the first placebo-controlled randomised study." Heart 93(5):585-90.

35. Lanza, G. A., A. Sestito, et al. (2005). "Effect of spinal cord stimulation onspontaneous and stress-induced angina and 'ischemia-like' ST-segmentdepression in patients with cardiac syndrome X." Eur Heart J 26(10): 983-9.


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36. Lapenna, E., D. Rapati, et al. (2006). "Spinal cord stimulation for patients withrefractory angina and previous coronary surgery." Ann Thorac Surg 82(5): 1704-8.

37. Yu, W., F. Maru, et al. (2004). "Spinal cord stimulation for refractory angina

pectoris: a retrospective analysis of efficacy and cost-benefit." Coron Artery Dis15(1): 31-7.

38. Borjesson M. et al. Spinal cord stimulation in severe angina pectoris-Asystematic review (2008) Pain 140;501-508


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Male, 45, office manager, no majorpsychosocial issue

One spine surgery to treat herniateddisc

Referred from primary care physicianto address axial back pain andsecondary radicular pain thatpersists six months following

anatomically corrective surgery Average back pain score (VAS) of

80/100 with diminished functional

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