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TREATMENT FOR LOW BACK PAIN: What Does Science Say?? Systematic Reviews of Common Chronic pain Medications and Interventions

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Title: TREATMENT FOR LOW BACK PAIN: What Does Science Say?? Systematic Reviews of Common Chronic pain Medications and Interventions


1
TREATMENT FOR LOW BACK PAIN What Does Science
Say??Systematic Reviews of Common Chronic pain
Medications and Interventions
  • Trang Nguyen MD, PhD, FAADEP
  • David C Randolph, MD, MPH, FAADEP
  • October 14, 2011
  • LWCC, New Orleans, LA.

2
Many Thanks to
  • Lloyd Colvin
  • Please note we have provided a number of
    references for you here today. If you have
    trouble getting these and need help, please ask
    Mr. Colvin and we will see to it a PDF is
    provided
  • Marjorie Eskay-Auerbach, MD, JD. For her expert
    assistance in material preparation.

3
A few facts about LBP
  • Mostly a self limited phenomenon
  • Definitions Sprain, Strain, Sprain/Strain
  • Historic information of paramount importance for
    determining likely source of pain
  • Nothing takes the place of a good history and
    physical exam

4
NON-SPECIFIC LOW BACK PAIN
5
Occurrence
  • LBP is the 5th most common reason for physician
    visits in the US
  • ¼ of US adults report low back pain lasting 1 day
    in the last 3 months
  • 7.6 report at least 1 episode of severe LBP
    within a 1 year period
  • Significant costs

6
NSLBP Presentation
  • Low back pain is pain, muscle tension, or
    stiffness, localized below the costal margin and
    above the inferior gluteal folds.
  • Acute lt 12 weeks
  • Chronic gt 12 weeks
  • Affects 70 of people in resource-rich countries
    at some point

7
Natural History
  • Many patients have self-limited episodes and do
    not seek care
  • Among those who seek medical care, pain,
    disability and RTW typically improve rapidly in
    the first month
  • Pengel LH, Herbert RD, Maher CG, Refshauge KM.
    Acute low back pain systematic review of its
    prognosis. BMJ. 2003327323
  • Up to one third of patients report persistent
    back pain of at least moderate intensity 1 year
    after an acute episode, and 1 in 5 report
    substantial limitations in activity
  • Von Korff M, Saunders K. The course of back pain
    in primary care. Spine. 1996212833-7
    discussion 2838-9

8
Classification Initial Triage
  • Focused History and Physical to identify
  • Non-specific low back pain (NSLBP)
  • LBP associated with radiculopathy or spinal
    stenosis
  • LBP associated with another specific spinal cause
  • Assessment of psychosocial risk factors that
    predict risk for chronic disability low back pain
  • No evidence suggests that labeling most patients
    with low back pain by using specific anatomical
    diagnoses improves outcomes (ACP/APS)

9
NSLBP Is Not - Diagnosis
  • In patients with back and leg pain, a typical
    history for sciatica (back and leg pain in a
    typical lumbar nerve root distribution) has a
    fairly high sensitivity but uncertain specificity
    for herniated disc
  • van den Hoogen HM, Koes BW, van Eijk JT, Bouter
    LM. On the accuracy of history, physical
    examination, and erythrocyte sedimentation rate
    in diagnosing low back pain in general practice.
    A criteria-based review of the literature. Spine.
    199520318-27. PMID 7732468
  • Vroomen PC, de Krom MC, Knottnerus JA. Diagnostic
    value of history and physical examination in
    patients suspected of sciatica due to disc
    herniation a systematic review. J Neurol.
    1999246899-906.

10
NSLBP Is Not - Diagnosis
  • Positive SLR (defined as reproduction of the
    patient's sciatica between 30 and 70 degrees of
    leg elevation)
  • relatively high sensitivity (91 95 CI, 82 to
    94)
  • modest specificity (26 CI, 16 to 38) for
    diagnosing herniated disc
  • Devillé WL, van der Windt DA, Dzaferagic A,
    Bezemer PD, Bouter LM. The test of Lasègue
    systematic review of the accuracy in diagnosing
    herniated discs. Spine. 2000251140-7
  • By contrast, the crossed straight-leg-raise test
    is
  • more specific (88 CI, 86 to 90)
  • less sensitive (29 CI, 24 to 34).

11
NSLBP Is Not - Diagnosis
  • Evidence on the utility of history and
    examination for identifying lumbar spinal
    stenosis is sparse
  • High-quality studies
  • modest or poor positive likelihood ratios (1.2
    for pseudoclaudication and 2.2 for radiating leg
    pain).
  • Changing symptoms on downhill treadmill testing
    are associated with the highest positive
    likelihood ratio (3.1).
  • Age older than 65 years was associated with a
    positive likelihood ratio of
  • Other findings have only been evaluated in
    lower-quality studies or are poorly predictive
    for lumbar spinal stenosis.

de Graaf I, Prak A, Bierma-Zeinstra S, Thomas S,
Peul W, Koes B. Diagnosis of lumbar spinal
stenosis a systematic review of the accuracy of
diagnostic tests. Spine. 2006311168-76.
12
Clinician must be satisfied that there is no
specific cause
13
Psychosocial Factors
  • Evidence is currently insufficient to recommend
    optimal methods for assessing psychosocial
    factors and emotional distress.
  • Psychosocial factors that may predict poorer low
    back pain outcomes include presence of
    depression, passive coping strategies, job
    dissatisfaction, higher disability levels,
    disputed compensation claims, or somatization
  • Pincus T, Burton AK, Vogel S, Field AP. A
    systematic review of psychological factors as
    predictors of chronicity/disability in
    prospective cohorts of low back pain. Spine.
    200227E109-20
  • Steenstra IA, Verbeek JH, Heymans MW, Bongers PM.
    Prognostic factors for duration of sick leave in
    patients sick listed with acute low back pain a
    systematic review of the literature. Occup
    Environ Med. 200562851-60

14
Imaging ACP/ACS
  • Clinicians should not routinely obtain imaging or
    other diagnostic tests in patients with
    nonspecific low back pain (strong recommendation,
    moderate-quality evidence).
  • Plain radiography is recommended for initial
    evaluation of possible vertebral compression
    fracture in selected higher-risk patients, such
    as those with a history of osteoporosis or
    steroid use
  • Jarvik JG, Deyo RA. Diagnostic evaluation of low
    back pain with emphasis on imaging. Ann Intern
    Med. 2002137586-97

15
Imaging ACP/ACS
  • Evidence to guide optimal imaging strategies is
    not available for low back pain that persists for
    more than 1 to 2 months despite standard
    therapies if there are no symptoms suggesting
    radiculopathy or spinal stenosis,

16
Imaging ACP/ACS
  • Prompt work-up with MRI or CT is recommended in
    patients who have severe or progressive
    neurologic deficits or are suspected of having a
    serious underlying condition (such as vertebral
    infection, the cauda equina syndrome, or cancer
    with impending spinal cord compression) because
    delayed diagnosis and treatment are associated
    with poorer outcomes
  • Loblaw DA, Perry J, Chambers A, Laperriere NJ.
    Systematic review of the diagnosis and management
    of malignant extradural spinal cord compression
    the Cancer Care Ontario Practice Guidelines
    Initiative's Neuro-Oncology Disease Site Group. J
    Clin Oncol. 2005232028-37
  • Todd NV. Cauda equina syndrome the timing of
    surgery probably does influence outcome. Br J
    Neurosurg. 200519301-6 discussion 307-8
  • Tsiodras S, Falagas ME. Clinical assessment and
    medical treatment of spine infections. Clin
    Orthop Relat Res. 200644438-50.

17
Imaging ACP/APS
  • Magnetic resonance imaging is generally preferred
    over CT if available because it does not use
    ionizing radiation and provides better
    visualization of soft tissue, vertebral marrow,
    and the spinal canal
  • Magnetic resonance imaging (preferred if
    available) or CT is recommended for evaluating
    patients with persistent back and leg pain who
    are potential candidates for invasive
    interventions plain radiography cannot visualize
    discs or accurately evaluate the degree of spinal
    stenosis
  • Jarvik JG, Deyo RA. Diagnostic evaluation of low
    back pain with emphasis on imaging. Ann Intern
    Med. 2002137586-97

18
Do medical interventionsmake a difference in
outcomes???
19
Long acting opioids Pain Function
  • Systemic review of 16 randomized controlled
    trials and 8 observational studies studying
    efficacy and safety of long-acting opioids in
    CNCP
  • n2617
  • Studies examined the use of long-acting opioids
    (taken twice a day) in CNCP patients
    transdermal fentanyl and long acting oral
    oxycodone, morphine, codeine, and dihydrocodeine
  • Efficacy regarding reducing pain and improve
    function
  • Adverse Effects
  • Subgroup analysis- which long acting opioid is
    more effective
  • Chou R, et al. J Pain and Symptom
    Management.2003 261026-1048

20
Long acting opioids Pain Function
  • Different studies used different assessments for
    pain intensity
  • Visual Analogue Scale (VAS) scale of 0-100 for
    no pain to severe pain.
  • Categorical Pain Scale
  • No scale
  • Only one study assessed quality of life with
    SF-36
  • Loss to follow up
  • Lack of adequate blinding
  • Chou R, et al. J Pain and Symptom
    Management.2003 261026-1048 Systematic Review
    Article

21
Long acting opioids Pain Function
  • Conclusions
  • Comparing 1 long acting opioid to another long
    acting opioid (2 trials)
  • Insufficient evidence from head to head
    comparison studies.
  • Comparing long acting opioids to other types of
    drugs or placebo (14 trials- mostly placebo, one
    trial with Darvocet, one trial with Cogentin)
  • There is insufficient evidence to suggest that
    long-acting opioid is superior to another in
    terms of efficacy.
  • Pain scales varied between trials.
  • Comparing long acting opioids to short acting
    opioids in improving pain and function (7 trials)
  • There is insufficient evidence
  • Chou R, et al. J Pain and Symptom
    Management.2003 261026-1048 Review Article

22
Efficacy Oral Opioids
  • Meta-analysis of 11 randomized, placebo
    controlled trials comparing oral opioids to
    placebo
  • n1025
  • Length 4 days-8 weeks
  • 388/1025 (38) had open label f/u beyond 8 weeks
  • Only 170 (44) were on opioids after therapy for
    7-24 months
  • Kalso E, et al. Pain. 2004 372-380. Systematic
    Review

23
Studies Oral Opioids
  • Calwell-1999 OA Oxycodone 40mg /day 4 weeks
  • Caldwell- 2002 OA Morphine 30mg/day 4 weeks
  • Gimbell 2003 DN Oxycodone 42mg/day 4weeks
  • Harke 2001 PNP Morphine 83mg/day 8 days
  • Huse 2001 Phantom Limb Pain Morphine 120mg/day
  • 4 weeks
  • Maier 2002 Mixed types Pain Morphine 114mg 4
    days
  • Moulin 1996 MSK pain Morphine 83.5mg 6
    weeks
  • Raja 2002 Post Herpetic Neuralgia Morphone
    91mg/day and Methadone 15mg/day 8 weeks
  • Roth 2000 OA Oxycodone 20mg or 40mg/day 2 weeks

24
Studies Oral Opioids
  • Watson 1998 Post Herpetic Neuralgia Oxycodone
    45mg/day 4 weeks
  • Watson 2003 DN Oxycodone 40mg 4 weeks
  • Kalso E, et al. Pain. 2004 372-380. Systemic
    Review

25
Function Oral Opioids
  • Function
  • 5/11 studies reported no significant difference
    in either self reported overall activity or ADL
  • 1/11 reported improved in disability (Maier,
    2002)
  • 2/11 reported lower disability scores during
    treatment (Watson 1998 and 2003)
  • Kalso E, et al. Pain. 2004 372-380. Systemic
    Review

26
Efficacy Oral Opioids
  • Mean decrease in pain intensity in most studies
    was at least 30 with the use of opioids compare
    to placebo
  • Effectiveness was comparable in neuropathic and
    nociceptive pain
  • However
  • Tolerance occurred in 6 patients at one year.
    Most patients required increased doses of opioids
  • Lower doses (Morphine 30 mg and Oxycodone 20 mg
    PO qd) were not effective
  • Side effects prevented from increasing dose
  • Only 3/11 trials used a validated quality of life
    questionnaire (SF-36 or Sickness Impact Profile)
  • Only 1/11 reported a difference in quality of
    life with opioids
  • We dont know if opioids improved quality of life
  • Kalso E, et al. Pain. 2004 372-380. Systemic
    Review

27
Opioids -Efficacy
  • Furlan A. Opioids for chronic noncancer pain a
    meta-analysis of
  • effectiveness and side effects. CMAJ. May
    23,2006. 174(11) p. 1589-94.
  • Meta-analysis
  • Methods
  • Literature search up to May 2005
  • Results
  • Total- 6019 patients with CNCP
  • 80 nociceptive pain, 12 neuropathic others
  • Ages 40-71 years average 58 years
  • 63 female and 85 white
  • Duration of therapy 1 week to 16 weeks

28
Results
  • 90 of the studies funded or had gt 1 author
    affiliated with pharmaceutical industry.
  • 17/41 RCTs have adequate randomization
  • 30/39 trials have adequate double-blinded
  • Drop out rate 33 - 38 (cases controls- side
    effects or inadequate pain relief)
  • Not all RCTs have adequate data for meta-analysis

29
Efficacy- Pain relief
  • Opioids vs. PLACEBO
  • 28 RCTs data available for meta-analysis
  • Results in favor of opioids
  • SMD -0.60, 95 CI -0.69 to -0.50
  • Standard mean difference
  • SMD Mean (case) Mean (controls)
  • pooled standard deviation
  • Conclusion persist with subgroup analysis of
    different opioids and methodological quality

30
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31
Efficacy- functional outcomes
  • Opioids vs. PLACEBO
  • 20 RCTs
  • Results favor opioids
  • SMD -0.31, 95 CI -0.41 to -0.22
  • Subgroup analysis
  • Long acting morphine compared to placebo was not
    statistically significant
  • Mixed pain subjects also do not have
    statistically significant functional relief with
    opioids

32
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33
Efficacy- Pain relief
  • Opioids vs. other ANALGESICS
  • 8 RCTs
  • Pain relief NOT statistically significant
  • SMD 0.05, 95 CI -0.32 to 0.21
  • Subgroup analysis did not change conclusions
  • NSAIDs, TCAs or methodological quality
  • Strong opioids (oxycodone and morphine) compared
    to NSAIDs or TCAs
  • Subgroup analysis was significant for pain relief
  • SMD- 0.34, 95 CI -0.67 to -0.01)

34
Efficacy- Pain relief
35
Efficacy- functional outcomes
  • Opioids vs. other analgesics
  • Other analgesics more effective
  • SMD 0.16, 95 CI 0.03 to 0.30

36
Efficacy- functional outcomes
37
Efficacy
  • Martell B. Systematic Review Opioid Treatment
    for Chronic Back Pain Prevalence, Efficacy, and
    Association with Addiction Ann Intern Med. 2007
    146 116-27.
  • Meta-analysis
  • Methods
  • Literature search up to March 2005
  • Chronic low back pain (gt 3 months)
  • Oral, topical or transdermal opioids

38
Efficacy
  • Results
  • 18 studies
  • 15 studies for final analysis- 3 excluded quality
    score poor
  • 1008 patients
  • 8/15 studies used randomized, double blind trial
  • 4/15 studies had placebo controlled
  • 11/15 trials sponsored by pharmaceutical
    companies

39
Efficacy- Pain relief
  • Results
  • Opioids vs. Nonopioids or Placebo
  • 4 RCTs- quality score excellent
  • Study duration- mean 64 days (7-16 weeks)
  • Patient retention- 67-99
  • Average morphine dose- 73mg/day (30-232mg/day)
  • (most trials do not have pretrial analgesia)
  • Nonsignificant pooled data

40
Efficacy- Opioids vs. nonopioids or Placebo
41
Efficacy- Pain relief
  • Opioids vs. other Opioids
  • 5 RCTs for meta-analysis
  • SMD- -0.93 95 CI -1.89 to -0.03 P 0.055
  • Nonsignificant reduction in pain
  • Sensitivity analysis- (randomized vs.
    non-randomized, study duration, study quality,
    sample size and dosages) did not change the
    conclusion

42
Efficacy- vs. other opioids
43
Efficacy- Pain relief
  • Conclusions
  • Meta-analysis (opioids vs. nonopioids or placebo)
    no significant effect
  • SMD- -0.199 95 CI -0.49 to 0.11 P 0.136
  • Sensitivity analysis- (study quality, sample
    size, study duration, and opioid dose) did not
    change SMD
  • Not more effective compared to other analgesics
    (NSAIDs or TCA)
  • Opioids have limited efficacy in treatment of
    CLBP

44
Conclusions
  • Efficacy
  • Comparing one opioids to another opioids- no
    significant effect

45
Conclusions
  • Problems
  • Short term follow up (max 16 weeks)
  • Study design- lack of information on follow up
  • Small sample size
  • Array of diagnostic criteria
  • Various functional outcome and pain score
    measurements
  • Improvement in pain not equivalent of function
  • No objective correlation

46
Opioids
  • Opioids in the Management of Chronic
  • Non-Cancer Pain An Update of American
  • Society of the Interventional Pain Physicians
    (ASIPP) Guidelines
  • Pain Physician 2008 Opioids Special Issue
    11S5-S62.

47
Summary of Evidence- Opioid Effectiveness
  • Based on the review of multiple systematic
    reviews
  • and the available literature, the evidence for
  • the effectiveness of long-term opioids
    (specifically transdermal Fentanyl and sustain
    release morphine) in reducing pain and improving
    the functional status for 6 months or longer is
    available but weak.
  • Noble M. J. Pain Symptom Manage 2008 35214-228.
    Systematic Review.
  • Trescot AM. Pain Physician 2008 11 S181-S200.

48
Opioids
  • For Oxycodone, the level of evidence is limited.
  • For Hydrocodone and Methadone, the level of
    evidence is non-existent (opinions- no published
    evidence regarding effectiveness with long term
    therapy)

49
Hydrocodone
  • There were no studies evaluating the
    effectiveness of hydrocodone even though this is
    the most commonly used drug.

50
RecommendationsOpioids
  • Based on the review of multiple systematic
    reviews
  • and the available literature, there is
    insufficient data for long term opioids with
    regards to efficacy and improve function.
  • Patients withdrew from clinical trials secondary
    to side effects (32 for oral therapy, 17 for
    transdermal) and insufficient pain relief (12
    oral therapy and 5 transdermal)
  • Substantial heterogeneity among oral studies
  • Many trials have removal of patients who do not
    respond leading to high drop out rate. Validity
    of the trials is questionable.

51
Opioid Therapy
  • G u i d e l i n e f o r t he Use of Chronic
    Opioid Therapy in Chronic Noncancer Pain-Evidence
    Review
  • The American Pain Society in Conjunction with the
    American Academy of Pain Medicine February 2009
  • Recommended Reading

52
Opioid Therapy
  • Criteria
  • Chronic non-cancer pain
  • Opioid- oral, transdermal, buccal, rectal, IM or
    SQ routes
  • IV and Intrathecal or Intraspinal routes excluded
  • Systematic reviews, RCTs, and Cohort Studies
  • See study for details

53
Comparing Long Acting Opioids
  • There is insufficient evidence from eight
    head-to-head trials (three higher-quality) and
    three observational studies to conclude that any
    long-acting opioid (sustained-release formulation
    or transdermal fentanyl) is more beneficial or
    less harmful than others.
  • Level of evidence moderate

54
Comparing sustained-release andimmediate-release
formulations of opioids
  • Seven trials (two higher-quality) found no clear
    differences in benefits or harms between
    sustained- and immediate-release opioids (level
    of evidence high).
  • Chou, 2003 systematic review.

55
Comparisons between different Tramadols
  • Six trials (three higher-quality) found no clear
    differences in benefits or harms between
    extended-release (once/day), sustained-release
    (twice/day), and immediate release Tramadol
    (level of evidence high).

56
Comparisons between Tramadol versus opioids
  • Three trials (one higher-quality) found no clear
    difference in efficacy between tramadol and
    different opioids. (level of evidence moderate).
    Evidence of differences in harms was
    inconclusive.
  • Jensen, 1994- OA- f/u 2 weeks, n 264
  • Mullican, 2001- OA or LBP- f/u 22 days, n 462
  • Wilder-Smith, 2001- OA- f/u 1month, n 57

57
Pharmacologic Management for Chronic Non-Cancer
Pain
  • Practice Guidelines for Chronic Pain Management
  • An Updated Report by the American Society of
    Anesthesiologists (ASA) Task Force on Chronic
    Pain Management and the American Society of
    Regional Anesthesia and Pain Medicine (ASRA)
  • April 2010

58
Opioid therapy
  • A meta-analysis of randomized controlled trials
    indicates that controlled or extended release
    opioid therapy (e.g., morphine, codeine, and
    oxycodone) provides effective pain relief for
    patients with low back pain or neuropathic
  • pain for assessment periods ranging from 1 to 9
    weeks,
  • with nausea or vomiting and constipation as side
    effects (Category A1 evidence).

59
Opioid therapy
  • Randomized controlled trials indicate that
    Tramadol provides effective pain relief for
    assessment periods ranging from 4 to 6 weeks
    (Category A2 evidence).

60
Opioid therapy
  • Studies with observational findings report that
    immediate release opioids, transdermal opioids,
    and sublingual opioids provide relief for back,
    neck, leg, and neuropathic pain for assessment
    periods ranging from 2 weeks to 3 months
    (Category B2 evidence).

61
Opioid therapy
  • ASA and ASRA members agree and consultants are
    equivocal as to whether opioids should be used
    for patients with neuropathic or back pain.
  • CAUTION REFERENCES ARE NOT AVAILABLE FOR REVIEW
  • Reference
  • 1. American Society of Anesthesiologists
    Practice guidelines for chronic pain management.
    ANESTHESIOLOGY 1997 869951004

62
Update on guidelines for the treatment of
chronic musculoskeletal pain
  • 2006
  • American College of Rheumatology (ACR)
  • European League Against Rheumatism (EULAR)
  • American Pain Society (APS)

63
Moderate to Severe LBP
  • Nociceptive / neuropathic pain
  • Long term
  • Elderly
  • Weak opioid combinations
  • Paracetamol (Tylenol)/tramadol
  • Tramadol
  • Strong opioids
  • Tramadol is efficacious for both nociceptive and
    neuropathic pain

64
Moderate to Severe LBP
  • Nociceptive / neuropathic pain
  • Long term
  • Young/Healthy
  • COX-2 inhibitors/NSAIDs (low dose)
  • /or paracetamol/tramadol (NSAID-sparing)
  • Tramadol
  • Strong opioids
  • Tramadol is efficacious for both nociceptive and
    neuropathic pain

65
Therapeutic options for treating
moderate-to-severe pain following injury
  • Pain intensity (moderate to severe)
  • 1. Non-selective NSAID (anti-inflammatory dose)
  • 2. / Paracetamol (full therapeutic dose)
  • 3. / Opioid combination
  • 4. / Tramadol (full therapeutic dose)
  • 5. Strong opioids

66
Therapeutic options for treating
moderate-to-severe pain following injury
  • Immediate Surgery
  • Do not use NSAIDs and start with
  • COX-2 inhibitor
  • /or opioid combination
  • /or opioid (weakstrong)

67
Therapeutic options for treating
moderate-to-severe pain following injury
  • If surgery considered
  • Stop NSAID 5 half-lives before operation and
    substitute with
  • COX-2 inhibitor
  • /or opioid combination
  • /or opioid (weakstrong)

68
Therapeutic options -supporting rehabilitation
  • Moderate to Severe Pain- (constant)
  • Paracetamol
  • /or opioid combination
  • /or weak opioid/
  • tramadol sustained release
  • /or strong opioid sustained release

69
Therapeutic options-supporting rehabilitation
  • Moderate to Severe Pain- Pain in motion/
    inflammatory
  • NSAID/COX-2 inhibitors for 35 days
  • Short-acting PRN opioid combination
  • Weak opioid/tramadol immediate release
  • Strong opioid immediate release
  • Depending on co-morbidities

70
Anticonvulsants
  • Cochrane Review- 2009, Issue 4
  • RCTs only
  • Trigeminal neuralgia, post herpetic, diabetic
    neuropathy, central pain post stroke, IBS, TMJ
    dysfunction
  • Mostly oral medication
  • Carbamazepine
  • Clonazepam
  • Gabapentin
  • Phenytoin
  • Sodium Valproate

71
Anticonvulsants
  • Results
  • 23 trials of 6 anticonvulsants
  • Acute pain- one trail placebo vs. sodium
    valproate- no evidence of effectiveness

72
Anticonvulsants
  • Chronic Pain- anti-convulsant is not first line
    medication
  • (except for trigeminal neuralgia).
  • Trigeminal Neuralgia
  • 3 trials of carbamazepine- NNT for effectiveness
    of 2.5
  • Post Herpetic Neuralgia
  • 1 trial of Gabapentin NNT 3.2
  • Diabetic Neuropathy (1 trial each)
  • Carbamazepine- NNT 2.3
  • Gabapentin NNT 3.8
  • Phenytoin NNT 2.1

73
Antidepressants
  • Meta-analyses of randomized controlled trials
    indicate that tricyclic antidepressants provide
    effective pain relief for a variety of chronic
    pain etiologies for assessment periods ranging
    from 2 to 8 weeks (Category A1
  • evidence).
  • In addition, meta-analyses of randomized
    controlled trials indicate that selective
    serotoninnorepinephrine reuptake inhibitors
    provide effective pain relief for a variety of
    chronic pain etiologies for assessment periods
    ranging
  • from 3 to 6 months (Category A1 evidence).
  • A meta-analysis of randomized placebo-controlled
    trials is equivocal
  • regarding the efficacy of selective serotonin
    reuptake inhibitors
  • in providing effective pain relief for diabetic
    neuropathy
  • (Category C1 evidence).

74
Antidepressants
  • Consultants, ASA members, and ASRA members
    strongly agree that tricyclic antidepressants
    should be used.
  • ASA members and ASRA members agree and
    consultants strongly agree that
    serotonin-norepinephrine reuptake inhibitors
    should be
  • used.

75
Benzodiazepines
  • One case report indicates that benzodiazepines
    can provide pain relief for up to 2 months for
    neuralgic pain syndrome (Category B3 evidence).
  • Consultants and ASRA members disagree and ASA
    members are equivocal with regard to whether
    benzodiazepines should be used for chronic pain.

76
Skeletal muscle relaxants
  • The literature is insufficient to evaluate
  • the efficacy of skeletal muscle relaxants in
    providing pain relief for patients with chronic
    pain (Category D evidence).
  • ASA members and ASRA members agree and
    consultants are equivocal with regard to whether
    skeletal muscle relaxants should be used for
    patients with chronic pain.

77
NSAIDs
  • Randomized controlled trials indicate that NSAIDs
    compared with placebo provide effective pain
    relief
  • for patients with back pain for assessment
    periods ranging from 2 to 12 weeks (Category A2
    evidence).
  • Consultants, ASA members, and ASRA members agree
  • that NSAIDs should be used for patients with
    back pain.

78
Topical agents
  • Randomized, placebo-controlled controlled
  • trials of topical agents (e.g., capsaicin,
    lidocaine, and ketamine) are equivocal regarding
    relief of peripheral pain for patients with
    neuropathic pain (e.g., diabetic neuropathy and
    postherpetic neuralgia) (Category C2 evidence).

79
Topical agents
  • Studies with observational findings indicate that
    topical agents (e.g., capsaicin,lidocaine, and
    ketamine) provide relief for peripheral
    neuropathic pain for assessment periods ranging
    from 3 to 6 weeks (Category B2 evidence).

80
Topical agents
  • Consultants, ASA members, and ASRA members agree
    that topical agents should be used for patients
    with peripheral neuropathic pain.

81
Summary
  • Anticonvulsants
  • Anticonvulsants (e.g., -2-delta calcium-channel
    antagonists, sodium-channel antagonists, and
    membrane-stabilizing drugs) should be used as
    part of a multimodal strategy for patients with
    neuropathic pain.

82
Summary
  • Antidepressants Tricyclic antidepressants and
    serotoninnorepinephrine reuptake inhibitors
    should be used as part of a multimodal strategy
    for a variety of patients with chronic pain.
    Selective serotonin reuptake inhibitors may be
    considered specifically for patients with
    diabetic neuropathy.

83
Summary
  • As part of a multimodal pain management
  • strategy, extended-release oral opioids should
    be used for neuropathic or back pain patients,
    and transdermal, sublingual, and
    immediate-release oral opioids may be used.

84
Summary
  • A strategy for monitoring and managing side
    effects, adverse effects, and compliance should
    be in place BEFORE prescribing any long-term
    pharmacologic therapy.

85
Treatment of Neuropathic Pain
  • Recommendations for the Pharmacological
    Management of Neuropathic Pain An Overview and
    Literature Update- March 2010
  • Treatment of Neuropathic Pain An Overview of
    Recent Guidelines
  • October 2009

86
Treatment of Neuropathic Pain
  • Comparison of Neuropathic Pain Treatment
    Guidelines, Excluding Trigeminal Neuralgia
  • Postherpetic neuralgia painful polyneuropathy
    Central pain
  • Medication Class NeuPSIG CPS EFNS
  • Tricyclic First line First line First line
  • (Nortriptyline (Pamelor) or Desipramine
    (Norpramin))
  • CPS Canadian Pain Society EFNS European
    Federation of Neurological Societies NeuPSIG
    Neuropathic Pain Special Interest Group
    (International Association for the Study of Pain)

87
Treatment of Neuropathic Pain
  • Comparison of Neuropathic Pain Treatment
    Guidelines, Excluding Trigeminal Neuralgia
  • Postherpetic neuralgia painful polyneuropathy
    Central pain
  • Medication Class NeuPSIG CPS EFNS
  • Ca. Channel ligands First line First line First
    line
  • (Gabapentin (Neurontin) and Pregablin (Lyrica))
  • CPS Canadian Pain Society EFNS European
    Federation of Neurological Societies NeuPSIG
    Neuropathic Pain Special Interest Group

88
Treatment of Neuropathic Pain
  • Comparison of Neuropathic Pain Treatment
    Guidelines, Excluding Trigeminal Neuralgia
  • Painful polyneuropathy
  • Medication Class NeuPSIG CPS EFNS
  • SSNRIs First line Second line Second line
  • (Cymbalta, Effexor)
  • CPS Canadian Pain Society EFNS European
    Federation of Neurological Societies NeuPSIG
    Neuropathic Pain Special Interest Group

89
Treatment of Neuropathic Pain
  • Comparison of Neuropathic Pain Treatment
    Guidelines, Excluding Trigeminal Neuralgia
  • Neuropathic pain
  • Medication Class NeuPSIG CPS EFNS
  • Topical Lidocaine First line Second line First
    line
  • 5 patch Localized peripheral NP PHN/allodynia
  • CPS Canadian Pain Society EFNS European
    Federation of Neurological Societies NeuPSIG
    Neuropathic Pain Special Interest Group

90
Treatment of Neuropathic Pain
  • Third Line Medications
  • Anti-depressant Medications
  • Bupropion (Wellbutrin), Citalopram (Celexa),
    Paroxetine (Paxil)
  • Anti-epileptic Medications
  • Carbamazepine (Tegretol), Lamotrigine (Lamictal)
    Oxcarbazepine (Trileptal), Topiramate (Topamax),
    Valproic Acid (Depakote)
  • Topicals
  • Capsaicin

91
Treatment of Neuropathic Pain
  • Reassess pain and health-related quality of life
    frequently
  • If substantial pain relief (e.g., average pain
    reduced to NRS lt3/10) and tolerable side effects,
    continue treatment.
  • If partial pain relief (e.g., average pain
    remains NRS gt4/10) after an adequate trial, add 1
    of the other first-line medications
  • If no or inadequate pain relief (e.g., lt30
    reduction) at target dosage after an adequate
    trial, switch to an alternative first-line
    medication.
  • If trials of first-line medications alone and in
    combination fail, consider second and third line
    medications or referral to a pain specialist or
    multidisciplinary pain center

92
Treatment of Neuropathic Pain
  • See Tables for the following
  • Starting dose
  • Titration
  • Maximum Dosage
  • Duration of Adequate Trial
  • Major side effects
  • Precautions
  • Other Benefits

93
Opioids for Chronic Non-Cancer Pain
  • Guidelines for outpatient prescription of oral
    opioids for injured workers with chronic,
    noncancer pain.
  • Washington State Department of Labor and
    Industries. Guidelines for outpatient
    prescription of oral opioids for injured workers
    with chronic, noncancer pain.
  • Olympia (WA) Washington State Department of
    Labor and Industries 2002 Aug.
  • 21 p. 28 references

94
Opioids for Chronic Non-Cancer Pain
  • Interagency Guideline on Opioid Dosing for
    Chronic Non-cancer Pain 2010 Update

95
What is New in this Revised Guideline
  • New data, including scientific evidence to
    support the 120mg MED dosing threshold
  • Tools for calculating dosages of opioids during
    treatment and when tapering
  • Validated screening tools for assessing substance
    abuse, mental health, and addiction

96
What is New in this Revised Guideline
  • Validated two-item scale for tracking function
    and pain
  • Urine drug testing guidance and algorithm
  • Information on access to mentoring and
    consultations (including reimbursement options)
  • New patient education materials and resources
  • Guidance on coordinating with emergency
    departments to reduce opioid abuse
  • New clinical tools and resources to help
    streamline clinical care

97
Recommended Principles for prescribing chronic
opioids
  • Single prescriber
  • Single pharmacy
  • Patient and prescriber sign opioid agreement
  • Lowest possible effective dose should be used
  • Be cautious when using opioids with conditions
    that may potentiate opioid adverse effects
    (including COPD, CHF, sleep apnea, current or
    past alcohol or substance abuse, elderly, or
    history of renal or hepatic dysfunction).
  • Do not combine opioids with sedative-hypnotics,
    benzodiazepines or barbiturates for chronic
    non-cancer pain unless there is a specific
    medical and/or psychiatric indication for the
    combination and increased monitoring is initiated

98
Recommended Principles for prescribing chronic
opioids
  • Routinely assess function and pain status
  • Monitor for medication misuse
  • Random urine drug testing to objectively assure
    compliance

99
Injection Therapy
  • Cochrane Review
  • Injection therapy for subacute and CLBP
  • 18 RCTs (ESI, facet injections, trigger points)
  • No statistical pooling secondary to heterogeneity
    of the trials
  • Conclusion There is insufficient evidence to
    support the use of injection therapy in subacute
    and CLBP.

100
Injection Therapy
  • Injection therapy for subacute and CLBP- An
  • Updated Cochrane Review. Staal JB, de Bie RA.
    Spine. Vol. 34, No.1, pp 49-59. 2009
  • ESI vs. Placebo Injections
  • 2 trials evaluate short term effects
  • One high quality and one low quality study
  • No significant result for pain relief or other
    outcomes

101
Injection Therapy
  • ESI vs. Other Treatments
  • 3 studies
  • ESI vs. NSAIDS ( low quality study)
  • ESI vs. Intrathecal Midazolam (low quality study)
  • ESI vs. morphine vs. ESI morphine (high quality
    study)
  • Limited evidence of no significant differences in
    short term pain relief

102
Injection Therapy
  • Facet Injections vs. Placebo Injections
  • 2 trials (1 high quality and 1 low quality)
  • Moderate evidence that facet joint injections are
    not significantly different from placebo
    injections for short-term pain relief and
    improvement of disability
  • Limited evidence that facet joint injections are
    not significantly different from placebo
    injections on work attendance.

103
Spinal Injection Procedures
  • Spinal Injection Procedures A Review of
    Concepts, Controversies, and Complications. Heran
    MK, Smith AD. Radiol Clin N. Am 46(2008) 487-514.
  • Nerve root injections are of limited use in the
    evaluation of spinal disorders with radicular
    features. Their variability in their technique
    and the heterogeniety in causative etiologies
    does not allow for critical appraisal of the
    existing data.

104
Spinal Injection Procedures
  • Long term efficacy of ESIs has not been shown
    with lack of a preferred method for
    administration of medications. The number and
    frequency of ESIs is arbitrary. Patients should
    not receive more than 3 injections in total.

105
Spinal Injection Procedures
  • Intra-articular facet blocks and medial branch
    blocks are equivalent when assessing a patient
    for facet denervation procedures. However, the
    false positive rates for both procedures are too
    high for them to be useful.
  • Rhizotomy procedures for facet-mediated pain do
    not provide sufficient long term relief to
    justify their use. The methods for evaluating
    which patients will benefit form these procedures
    are flawed, with no uniformity in how these
    procedures are performed.

106
Spinal Injection Procedures
  • CT fluoroscopy adds nothing to percutaneous
    spinal injection procedures and only increases
    radiation exposure to the patient and the
    operator.
  • Symptomatic synovial cysts are best managed
    surgically.

107
Spinal Injection Procedures
  • Complications
  • Spinal injection procedures can be associated
    with potentially devastating complications and
    should not be performed because there are limited
    data to support their efficacy as diagnostic and
    therapeutic procedures.

108
Spinal Injection Procedures
  • Potential complications from facet denervation
    procedures
  • Infection
  • Bleeding
  • Painful cutaneous dysesthesia
  • Pain caused by neurogenic inflammation
  • Pneumothorax
  • Damage to spinal nerve or motor branches

109
Interventional Therapies, Surgery, and
Interdisciplinary Rehabilitation for LBP
  • Interventional Therapies, Surgery, and
    Interdisciplinary Rehabilitation for LBP An
    Evidence Based Clinical Practice Guideline from
    the American Pain Society. SPINE. V. 34, No. 10,
    pp 1066-1077. 2009
  • Surgery for Low Back Pain A Review for the
    Evidence for an American Pain Society Clinical
    Practice Guideline. Chou R, Baisden J, Carragee
    EJ. SPINE V. 34, No. 10, pp 1094-1109. 2009

110
Prolotherapy
  • Condition NS LBP
  • Level of Evidence Good consistent results from
    well designed, well conducted studies at least 2
    higher quality trials.
  • Net Benefit No benefit
  • Grade Panel recommends against the intervention.

111
Intradiscal steroid injection
  • Condition Presumed discogenic pain
  • Level of Evidence Good consistent results from
    well designed, well conducted studies at least 2
    higher quality trials.
  • Net Benefit No benefit
  • Grade Panel recommends against the intervention.

112
Facet injection
  • Condition Presumed facet pain
  • Level of Evidence Fair at least 1 higher
    quality trial, gt2 higher quality trials with some
    inconsistency, or gt2 lower quality trials with
    consistent results, or multiple consistent cohort
    studies.
  • Net Benefit No benefit
  • Grade Panel recommends against the intervention.

113
Botulinum toxin injection
  • Condition NS LBP
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

114
ESI
  • Condition NS LBP
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

115
Medial Branch Block (therapeutic)
  • Condition Presumed Facet joint pain
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

116
Radiofrequency denervation
  • Condition Presumed facet joint pain
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

117
Radiofrequency denervation
  • Condition Presumed discogenic pain
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

118
Percutaneous Intradiscal Radiofrequency
thermocoagulation
  • Condition Presumed Facet joint pain
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

119
Coblation Nucleoplasty
  • Condition Presumed discogenic pain
  • Level of Evidence NO trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

120
Spinal cord Stimulation
  • Condition NS LBP
  • Level of Evidence NO trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

121
Intrathecal therapy
  • Condition NS LBP
  • Level of Evidence NO trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

122
RF Denervation
  • Condition Radiculopathy
  • Level of Evidence poor- large and unexplained
    inconsistency between higher quality trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

123
Coblation Nucleoplasty
  • Condition Radiculopathy with prolapsed lumbar
    disc
  • Level of Evidence NO trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

124
Spinal cord Stimulation
  • Condition Radiculopathy with prolapsed lumbar
    disc
  • Level of Evidence NO trials
  • Net Benefit Unable to estimate
  • Grade Evidence that the intervention is
    effective is lacking, of poor quality, or
    conflicting and the balance of benefits and harms
    cannot be determined.

125
ESI
  • Condition Radiculopathy with prolapsed lumbar
    disc
  • Level of Evidence Fair at least 1 higher
    quality trial, gt2 higher quality trials with some
    inconsistency, or gt2 lower quality trials with
    consistent results, or multiple consistent cohort
    studies.
  • Net Benefit MODERATE for SHORT TERM only ( 3
    months)
  • Mean 10-20 point improvement of VAS pain scale
  • Mean 10-20 point improvement of ODI scale, 2-5
    points on RDQ, or equivalent
  • Grade Panel recommends the intervention. at
    least fair evidence that intervention improves
    health outcomes, benefits moderately outweigh
    harms OR
  • Benefits are small but there are no significant
    harms, costs or burden associated with the
    intervention.

126
SCS
  • Condition FBSS with persistent radiculopathy
  • Level of Evidence Fair at least 1 higher
    quality trial, gt2 higher quality trials with some
    inconsistency, or gt2 lower quality trials with
    consistent results, or multiple consistent cohort
    studies.
  • Net Benefit MODERATE
  • Mean 10-20 point improvement of VAS pain scale
  • Mean 10-20 point improvement of ODI scale, 2-5
    points on RDQ, or equivalent
  • Grade Panel recommends the intervention. at
    least fair evidence that intervention improves
    health outcomes, benefits moderately outweigh
    harms OR
  • Benefits are small but there are no significant
    harms, costs or burden associated with the
    intervention.

127
Intradiscal steroid injection
  • Condition Radiculopathy with prolapsed lumbar
    disc
  • Level of Evidence Fair at least 1 higher
    quality trial, gt2 higher quality trials with some
    inconsistency, or gt2 lower quality trials with
    consistent results, or multiple consistent cohort
    studies.
  • Net Benefit NO effect vs. chemonucleolysis (NO
    TRIALS VS. PLACEBO)
  • Grade Benefits only slightly outweigh harms, or
    the balance of benefits and harms are too close
    to justify a general recommendations

128
Review article
  • Injection therapy and denervation procedures for
    chronic low back pain a systematic review
  • Henschke N. Eur Spine J. (2010) 19 1425-1449

129
Chemonucleolysis
  • One RCT (chemonucleolysis vs. discectomy)
  • n68 subjects
  • Limitations in design, inconsistency and
    imprecision
  • Chemonucleolysis is no more effective than
    discectomy over long term follow up

130
Facet joint injections
  • Facet joint injections (corticosteroids vs.
    placebo)
  • 2 RCTs
  • Low quality evidence that there is no significant
    difference in effect between facet joint
    injections with corticosteroids and placebo
    injections for short to intermediate term pain
    relief and improvement in function.

131
Facet joint injections
  • 5 RCTs
  • (RCTs corticosteroid vs. lidocaine vs. home
    exercise vs. sodium hyaluronate injections vs.
    local anesthetics only vs. sarapin)
  • There is very low quality evidence that facet
    injections with corticosteroids are more
    effective than the comparison treatment.

132
ESI
  • RCTs
  • Corticosteroid vs intrathecal benzodiazepine
  • Steroid with targeted epidural local anesthetic
    vs. steroid with spinal endoscope
  • Epidural with ropvacaine vs. epidural with
    bupivacaine
  • There is low quality evidence that there is no
    significant difference in the different methods
    studied
  • Post treatment, no significant differences
    between the groups were reported for pain relief
    or general improvement

133
IM injections
  • B12
  • 1 RCT B12 vs. placebo
  • Low quality evidence that Vit. B12 injections are
    more effective than IM placebo injections for
    short term pain relief and improvement in
    function.

134
IM injections
  • Botulinum Toxin A
  • 1 RCT Botox vs. placebo saline
  • Low quality evidence that Botox A injections are
    more effective for pain relief in the short and
    intermediate term than placebo.

135
Percutaneous Intradiscal RF thermocoagulation
  • 3 RCTs (Percutaneous Intradiscal RF
    thermocoagulation vs. placebo)
  • Low quality evidence that there is no difference
    between Percutaneous Intradiscal RF
    thermocoagulation and placebo in pain and
    function status over intermediate or long term
    follow up.

136
Intradiscal electrothermal therapy (IDET)
  • Intradiscal electrothermal therapy vs. Placebo
  • 2 RCTs
  • Low quality evidence that IDET is more effective
    than placebo for pain relief or functional
    improvement over long term (6 months).

137
RF denervation of facet joints
  • RF denervation of facet joints vs. placebo
  • 5 RCTs
  • Low quality evidence that RF denervation is more
    effective than placebo for pain relief (short
    term and long term) or functional improvement
    over short term.

138
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