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Interventional Pain Management: A Critical Review

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Title: Interventional Pain Management: A Critical Review


1
Interventional Pain Management A Critical Review
  • Mark S. Wallace, M.D.
  • Professor Clinical Anesthesiology
  • University of California, San Diego

2
Pain Treatment Continuum
Most invasive
Least invasive
Continuum not related to efficacy
Psychological/physical approaches
Topical medications
Oral medications
Interventional techniques
Consider referral if previous treatments were
unsuccessful.
35
3
Indications for Interventional Pain Management
  • Pain unrelieved by conservative management
  • Unacceptable side effects with systemic therapies
  • Patient desire to avoid systemic therapy
  • Pain Crisis

4
Therapeutic Considerations Setting Priorities
  • Efficacy
  • clinical trial data
  • clinical experience
  • Safety/tolerability
  • Ease of use
  • frequency
  • patient acceptability
  • Cost

48
5
Interventional Pain Management Neural Blockade
  • Diagnostic Blockade
  • Used to identify the pain generator
  • Prognostic Blockade
  • Used to determine if definitive procedure is
    indicated
  • Therapeutic Blockade
  • Prolonged pain relief with single series
  • In conjunction with physical therapy

6
Challenges in applying high levels of evidence to
surgical or minimally invasive procedures
  • Ethical limitations of blinded surgical
    techniques
  • Placebo use that prolong suffering and yet expose
    to surgical risk
  • Cost prohibition
  • Difficulties in blinding sham procedures
  • Ability to recruit adequate numbers

7
Interventional Therapies for Low Back Pain
  • Epidural Steroid Injection
  • Sacroiliac Joint Injection and RFA
  • Facet Joint Injection and RFA
  • Discography
  • IDET, Nucleoplasty, Disc RFA
  • Spinal Cord Stimulation
  • Spinal Drug Delivery

8
Epidural Steroid Injections
  • Rationale
  • Nucleus Pulposis is rich in proinflammatory
    mediators including phospholipase A,
    interleukins, and proteoglycans
  • Localized placement of steroids will maximize
    anti-inflammatory effect, thus reducing symptoms

9
Epidural Steroid Injection Techniques Interlaminar
(1), Transforaminal (2), Caudal (3)
2
2
3
1
3
10
Randomized Trials of Caudal Epidural Steroid
Injections for Lumbar Sciatica and Post Lumbar
Laminectomy Pain
Author
Participant
Outcome
- double blind study
11
Randomized Controlled Trials of Interlaminar
Epidural Steroids for Lumbar and Cervical
Radiculopathy
Author
Participant
Outcome
-double blind study
12
Randomized Trials of Transforaminal Epidural
Steroid Injections for Lumbar Radiculopathy
Author

Outcome
-All studies double blind
13
Epidural Steroid Injections Safety and
Complications
  • Cervical
  • Interlaminar Dural puncture, spinal cord injury
  • Transforaminal STROKE, nerve root injury
  • Thoracic
  • Interlaminar Dural puncture, spinal cord injury
  • Transforaminal Pneumothorax, nerve root injury
  • Lumbar
  • Interlaminar Dural puncture
  • Transforaminal Nerve root injury

14
Cervical Transforaminal Epidural Steroid
  • Neurological Events After Cervical Epidural
    Steroid Injection
  • 1340 surveys mailed to APS
  • members
  • 286 returned
  • 61 responses detailed 78 serious neurological
    events
  • 13 cerebellar basilar infarcts
  • 11 spinal cord infarcts
  • 12 deaths
  • Scanlon and Wallace, 2004

Vertebral Artery
15
Central Canal Injection of Spinal Cord
16
Facet Joint Injection
  • Facet Joint as a Source
  • of Chronic Spinal Pain
  • 15-45 low back
  • -Schwartzer, Spine, 1994
  • 48 thoracic
  • -Manchikanti, Pain Physician, 2002
  • 54-67 neck
  • -Barnsley, Spine, 1995

17
Facet Joint Injection Diagnostic Value
  • False Positive Rates
  • 27-63 cervical
  • -Barnsley, Clin J Pain, 1993
  • 58 thoracic
  • 22-47 low back
  • -Schwarzer, Pain, 1994

18
Facet Joint Injection Prognostic Value
No evidence that diagnostic facet injections
predict outcome of radiofrequency Lesioning
19
Facet Joint Injection Therapeutic Value
  • Very little if any
  • therapeutic value of
  • facet blocks whether
  • using medial branch
  • blocks or intra-articular
  • Steroids
  • -Carette, NEJM, 1991 Bransley, NEJM, 1994

20
Facet Joint Injections Safety and Complications
  • Cervical
  • Vertebral artery damage
  • Transient ataxia and unsteadiness
  • Phrenic nerve block with C3-C6 blocks
  • Capsule rupture
  • Thoracic
  • Pneumothorax
  • Capsule rupture
  • Lumbar
  • Capsule rupture

21
Sacroiliac Joint Pain
  • Innervated from lumbosacral
  • segments
  • Incidence ranges from 10-30
  • -Schwarzer, 1995 Mainge, 1996 Manchikanti, 2001
  • Pang, 1998
  • Often a secondary cause of back
  • pain

22
Sacroiliac Joint Injection Diagnostic Value
  • False Positive Rates
  • 20 single injections
  • -Maigne, 1996
  • Less with control
  • injections
  • -Manchikanti, 2001 Pang, 1998

23
Sacroiliac Joint Injection Therapeutic and
Prognostic Value
  • No studies evaluating the therapeutic value of SI
    joint injections
  • No studies evaluating the prognostic value of SI
    joint injections as a predictor of radiofrequency
    lesioning success

24
Sacroiliac Joint Injections Safety and
Complications
  • Minimal safety and complication concerns
  • Possible injury to the sciatic nerve

25
Radiofrequency Ablation Techniques
  • High temperature ablation
  • Ablates all nerve fibers
  • Low temperature pulsing
  • Mechanism unclear but may result in long term
    changes in nervous system function resulting in
    pain relief

26
Randomized Trials of Medial Branch Neurotomy for
Neck and Low Back Pain
Author
Participant
Outcome
27
Radiofrequency Neurotomy Safety and Complications
  • Minimal safety and complication concerns
  • Possible neuritis or cutaneous dysesthesias

28
Discography
  • No innervation of inner
  • 2/3 of annulus and
  • entire nucleus
  • Outer 1/3 of annulus
  • highly innnervated
  • -Freemont, Lancet, 1997l Konttinen, Spine, 1990
  • Prevalence of internal
  • disc disruption in low
  • back pain is 39
  • -Schwarzer, Spine, 1995

29
Discography Diagnostic Value
LOW PRESSURE (lt50mm Hg) And/or LOW VOLUME (lt1.2
ml) With familiar pain reproduction AND Negative
control discs
Entry Point
X
30
Discogram Diagnostic Value
  • The accuracy of discography in the
  • Diagnosis of disc disruption is high
  • The accuracy of discography in the
  • diagnosis of discogenic pain is
  • controversial and studies have
  • shown conflicting results (i.e.,
  • positive pain in asymptomatic
  • subjects).
  • -Holt, J Bone Joint Surg, 1968 Walsh, J Bone
    Joint Surg, 1990
  • More recent studies with refined
  • techniques show a much lower false
  • positive rate
  • -Carragee, Spine, 2000 Derby, Spine, 1999

31
Discography Prognostic Value
  • Discography is used to predict the outcome
  • of a variety of invasive procedures including
  • IDET, percutaneous disc decompression,
  • and surgical fusion
  • Numerous studies have yielded conflicting
  • results and no firm conclusions can be made
  • -Derby, Spine, 1999 Gill, Spine, 1992
  • Discography should be viewed as an invasive
  • test to be used only when results of other
  • tests are equivocal or inconsistent

32
Discography Safety and Complications
  • Discitis
  • Risk can be minimized with perioperative
    antibiotics and double needle technique
  • Most common organisms are Staph. Aureus, Staph.
    Epi, and E coli.
  • Nerve root trauma
  • Back pain

33
Intradiscal Electrothermal Annuloplasty
  • Rationale
  • Weakened annulus results in a leakage of the
    nucleus polposus into outer layers of annulus and
    an proliferation of C fibers into inner layers of
    annulus
  • Heating the annulus results in a remodeling of
    the weakened annulus and a neurolysis of the C
    fibers

34
Intradiscal Electrothermal Annuloplasty
  • One randomized double blind placebo controlled
    trial demonstrated a significant improvement in
    pain, Oswestry, BPI, physical functioning, and
    mental health at 6 months
  • Pauza, Spine, 2004

35
Intradiscal Electrothermal Annuloplasty Safety
and Complications
  • Discitis
  • Risk can be minimized with perioperative
    antibiotics and double needle technique
  • Most common organisms are Staph. Aureus, Staph.
    Epi, and E coli.
  • Nerve root trauma
  • Back pain
  • Catheter breakage
  • Post IDET disc herniation
  • Cauda equina syndrome

36
Percutaneous Disc Decompression
  • Multiple techniques have emerged
  • Nucleoplasty
  • LASE
  • Dekompressor
  • Rationale
  • Reduced volume of disc material results in
    reduced intradiscal pressure
  • Evidence is limited showing the effectiveness of
    these procedures

37
Epidural Adhesiolysis
  • Multiple techniques have emerged
  • Single or multiple infusions of hypertonic saline
  • Endoscopic guided lysis of epidural adhesions
  • Rationale
  • Spine surgery results in the accumulation of
    scarring in the epidural space that compresses
    nervous tissue
  • Epidural adhesiolysis removes the scar
  • Evidence is limited showing the effectiveness of
    these procedures

38
Sympathetic Blockade
  • Rationale
  • Nerve Injury Leads to
  • Cross talk between sympathetic
  • and afferent fibers
  • Activation of sympathetic
  • efferent evokes activity in small afferents
  • Sympathetic Sprouting in peripheral
  • terminals and DRG
  • Increase in catecholamine receptors
  • Drummond et al, 1996 Devor 1981 Devor, 1990
    McLachlan, 1993

39
Sympathetic Blockade Techniques
Stellate Ganglion Block
Lumbar Sympathetic Block
40
Sympathetic Blockade for CRPS
  • There is a lack of prospective studies evaluating
    the efficacy of sympathetic blockade for the
    treatment of CRPS
  • 3 reviews reported limited support of IV regional
    anesthesia
  • Kingerly, 1997 Tanelia, 1996, Cepeda, 2002
  • 1 randomized blinded trial showed IV regional
    with bretylium/lidocaine was superior to
    lidocaine alone
  • Hord, 1992

41
Sympathetic Blockade for CRPS
  • Expert Panel Recommendations
  • Current guidelines recommend interdisciplinary
    management, emphasizing 3 core treatment
    elements pain management, rehabilitation,
    psychological treatment. The best therapeutic
    regimen has not been established. Increasing
    evidence suggests that some cases are refractory
    to conservative measures and require flexible
    application of various treatments as well as
    early consideration of invasive interventions.
  • -Stanton-Hicks, et al, 2002

42
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43
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44
Spinal Drug Delivery
  • Opioids
  • Clonidine
  • Bupivacaine
  • Baclofen
  • Ziconotide
  • Drug Compounding

45
Problems with Efficacy Studies on Intraspinal
Drug Therapy
  • Lack of psychological assessment
  • Screening methods not described
  • No control groups, randomization, or blinding
  • Pain syndromes not defined
  • No standardization of methods used to determine
    outcome
  • No protocols for selecting, increasing, or
    changing drugs used
  • Studies are short to intermediate in follow-up

46
Literature Review Intrathecal Morphine
  • No. of Good Excellent
  • Reference Patients Indication Pain Relief
  • Onofrio, Yaksh, 1990
  • J. of Neurosurgery 53 Cancer 64
  • Penn, Paice, 1987 35 Cancer
  • J. of Neurosurgery 43 8 Non-malignant 84
  • Shetter, 1986
  • Neurosurgery 14 Cancer 79
  • Krames, Gershow, 1985
  • Cancer 17 Cancer 88
  • Auld, Jokela, 1985
  • Spine 26 Non-malignant 81

47
Mechanism of Action Ziconotide Blocks Synaptic
Transmission of Primary Nociceptors
  • Presynaptic calcium channels (CCs) trigger
    calcium-dependent transmitter release
  • Ziconotide blocks presynaptic N-type calcium
    channels, or NCCs

48
Primary Efficacy Mean Percent Improvement in
VASPI From Baseline To Week 3
12
p0.04,
5
95 confidence interval for treatment difference
0.4 - 13
49
Spinal Drug Delivery vs Comprehensive Medical
Management in Cancer Pain
  • Randomized Controlled Trial
  • 202 cancer patients with uncontrolled pain
    randomized to either Intrathecal Drug Delivery
    System (IDDS) or Comprehensive Medical Management
    (CMM).
  • Clinical success defined as gt/ 20 reduction in
    VAS scores or equal scores with gt/ 20 reduction
    in toxicity.
  • More IDDS patients achieved success (84.5 vs
    70.8, p.05)
  • More IDDS patients achieved gt/20 reduction in
    both pain VAS and toxicity
  • Nonsignificant change in mean VAS between groups
    (IDDS-52, CMM-39)
  • IDDS patients had significantly greater change in
    toxicity scores (52 vs 17, p.004)
  • No differences in survival between groups

Smith et al, 2002
50
Drug Mixtures/Compounding
  • PROS
  • Targets Multiple Mechanisms
  • Attenuates Tolerance
  • Drug Synergism
  • CONS
  • Drug Compatibility Issues
  • Potency
  • Solubility
  • Drug Precipitation at High Concentrations
  • Granuloma formation?

51
Granuloma Formation with Chronic Spinal Drug
Delivery
Lumbar
Dura
Catheter
52
Economics of Intraspinal Drug Delivery
  • 5-year cost analysis for intrathecal morphine vs.
    medical management for failed back surgery
    Intrathecal drug therapy was less expensive than
    medical management at 22 months
  • Lissovoy et al., 1997
  • Intrathecal drug delivery vs. oral or transdermal
    drug delivery Assuming a 5 monthly increase in
    dose requirements, at 25 months, intrathecal drug
    delivery is less expensive than oral or
    transdermal drug delivery
  • Hassenbusch et al., 1997

53
Spinal Cord Stimulation
54
Spinal Cord Stimulation
  • Rationale
  • When Sensory Impulses Are Greater Than Pain
    Impulses
  • Gate in the Spinal Cord Closes Preventing the
    Pain Signal From Reaching the Brain
  • SCS Implanted Near Dorsal Column Stimulates the
    Pain-inhibiting Nerve Fibers Masking Painful
    Sensation With a Tingling Sensation (Parathesia)

Pain
GATE
Sensory
Pain
GATE
SCS
Sensory
55
Stimulation Targets
  • Dorsal Columns
  • Contain secondary sensory (afferent) fibers
  • Stimulation produces paresthesia over large areas
    of selected regions corresponding to level of
    cathode below

56
Illustration of Multiple Independent Current
Control Fractionalization
Multiple Independent Current Control One Current
Source for Each Contact
Single-Source Control One Voltage or Current
Source for All Contacts
I
I
I
V/I
V/I
57
Spinal Cord Stimulation
  • EFFICACY
  • Most studies are retrospective and report a
    50-70 success rate (gt50 reduction in pain) with
    follow-ups ranging from 3-7 years
  • North, 1993 Kumar, 1991
  • Studies on re-operation for failed back
    demonstrate poor outcomes
  • North, 1991
  • Studies using improved technology have not been
    done

58
Spinal Cord Stimulation
59
Spinal Cord Stimulation
  • ECONOMICS
  • Review of 14 patients, on average, recipients of
    SCS paid for itself within 5.5 years. In
    patients in whom SCS was clinically efficacious,
    the system paid for itself within 2.1 years
  • Bel and Baner, 1991
  • Studies are lacking using the newer rechargable
    battery technology

60
Determining Level of Evidence Agency for
Healthcare Research and Quality Criteria
  • Conclusive multiple high quality scientific
    studies or consistent reviews of metanalysis
  • Strong At least one properly designed
    randomized, controlled trial of appropriate size
    OR multiple properly designed studies of smaller
    size OR at least one randomized trial
    supplemented by prospective and/or retrospective
    evidence
  • Moderate well designed small randomized trial OR
    well designed trials without randomization OR
    quasi-randomized studies, single group, pre-post
    cohort, time series OR matched case-controlled
    studies OR at least one meta-analysis
  • Limited well designed non-experimental studies
    from more than on center or research group
  • Intermediate opinions of respected authorities,
    based on clinical evidence, descriptive studies,
    or reports of expert committees

AHRP Publication No. 02-E016, April, 2002
61
Evidence on the Validity of Diagnostic Injections
Manchikanti et al, 2003
62
Evidence on the Validity of Therapeutic
Interventions
Manchikanti, et al, 2003
63
Summary
  • The efficacy of interventional therapies for pain
    management is difficult to determine due to the
    challenges of clinical trial design
  • Most trials are retrospective and of the
    prospective randomized trials, very few are
    blinded
  • As a single therapeutic modality, interventional
    therapies are less likely to be effective than
    when applied with comprehensive management
    including medical, psychological and
    rehabilitative therapies
  • Beware of the Block Shops

64
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