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BACK PAIN - CHRONICISSUES
David Borenstein, MDClinical Professor of Medicine
Arthritis and Rheumatism Associates
The George Washington University
Medical Center
Washington, DC
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Chronic Low Back PainIssues for Discussion
1. Define the forms of chronic low back pain andits prevalence (Is it frequent and important
enough to study?)
2. Will patient selection including etiology and
severity influence the performance of drugs in
development? (Is it possible to identify and
separate the individuals with back pain?)
3. Which are the appropriate outcome measures?(Can improvements in back pain related to
therapy be determined?)
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Chronic Low Back Pain
Issues for Discussion
4. Will a general indication be useful for different
labeling claims? (somatic v. neuropathic v.chronic headache)
5. Chronic low back pain - serve as a measure of
efficacy for a general chronic pain indication or
specific indication for chronic low back pain
alone
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WHAT IS CHRONICLOW BACK PAIN
And
ITS PREVALENCE?
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LOW BACK PAIN -
DEFINITIONPain that occurs in an area with boundaries
between the lowest rib and the crease of the
buttocks
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Chronic Low Back Pain
Duration greater than 3 months
Pain that persists longer than theexpected time period for healing
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Epidemiology of Low Back Pain
20% of the US population develops back
pain yearly
Back pain -second most common cause of
disability in the US (leading cause among
men) accounting for 16.5% of the totaldisabilities in > 18 yo in 1999
Workers compensation 1986-1996 - > 1
year 8.8% of claims - 64.9%-84.7% ofannual costs
___________________________________
CDC. MMWR 2001;50:120-125Hashemi L et al: J Occup Environ Med 1998;40:1110-1119
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Natural History of Low Back Pain
443 LBP subjects postal questionnaire 12 months
15 general practices Amsterdam, Netherlands
269 completed survey - less pain answered less often
7 weeks-median time to recover
At 12 weeks-35%, 52 weeks-10% had LBP
75% had 1 or more relapses during study
Pain and disability was less during relapses
Time to relapse-median 7 weeks, duration-median 6weeks
__________________________________________van den Hoogen et al: Ann Rheum Dis 1998;57:13-19
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Low Back Pain - Disorders
Mechanical Referred
Rheumatologic Hematologic
Infectious NeurologicNeoplastic Psychiatric
Endocrinologic Miscellaneous
(N > 60)
_____________________________________Borenstein D, Wiesel S, Boden S: Low Back Pain: Medical Diagnosis and
Comprehensive Management. 1995
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Low Back Pain - Disorders
Mechanical - 85% of all low back pain
Muscle, ligament, tendon strain
Discogenic disorders including herniated disc
Apophyseal joint arthritis
Spinal stenosis
Spondylolysis, spondylolisthesis
Scoliosis
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Sources of Low Back Pain
Superficial somatic - skin
Deep somatic - muscle, joint, tendon, bursa,
fascia
Radicular - nerve root
Visceral referred - sympathetic afferents
Neurogenic - mixed motor sensory nerves
Psychogenic - cerebral cortex
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Pain Intensity
Minimal - mentioned in passing, normal
function
Mild - component of symptoms, mild
dysfunction
Moderate - major component of symptoms,
alters function
Severe - the disease symptom,
incapacitating function
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Diagnostic Evaluation
Diagnosis of low back pain is unspecified
in 80% of patients
_________________________________________Dillane JB et al: Acute back syndrome: a study from general practice.
BMJ. 1966;2:82-84Rowe ML: Low back pain in industry: a position paper. J Occup Med
1969;11:161-169
White AA, Gordon S. Symposium on Idiopathic Low Back Pain.
Mosby Co. 1982
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LOW BACK PAIN -
DIAGNOSIS Specific diagnosis is possible
Differentiation of muscle, joint,
ligamentous structures
Mechanical versus systemic disorders is
possible
Categorize by clinical symptoms
Subtyping will improve therapy
_____________________________________Abraham I, Killackey-Jones B: Arch Intern Med 2002;162:1442-1444
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LOW BACK PAIN -
DIAGNOSIS Specific diagnosis is impossible
Anatomic abnormalities in asymptomatic
individuals
Overutilization of imaging techniques
Inconsistency of physical findings
Non-specific therapy is effective
____________________________________Deyo RA: Arch Intern Med 162:1444-1446, 2002
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LOW BACK PAIN -
DIAGNOSIS Somatic v. neuropathic v. radicular pains
can be differentiated
Specific pain generators (individual joint ormuscle) are difficult to identify but
localization is not essential for effective
therapy
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Chronic Back Pain - Outcome
Measures Back specific function
Pain
Patient global satisfaction
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Back Pain - Outcome Measures
Back Specific Function
Roland Morris Disability
Questionnaire
Oswestry Disability Index
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Back Pain - Outcome Measures
Roland-Morris Disability Questionnaire -
function assessment
24 items from the Sickness Impact Profile
Functions affected by back pain that day
Scores added ( 0-no disability to 24 -
maximum disability)
Validated and reproducible instrument
___________________________________Roland M, Morris R: Spine 1983;8:141-144
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Back Pain - Outcome Measures
Oswestry Disability Index - pain and functionassessment
10 sections on various functions with 6
levels of assessment
Physical and social functions that day
Scores added (0-no disability to 100-
maximum disability) Validated and reproducible instrument
_____________________________________
Fairbank J, Pynsent P: Spine 2000; 25:2940-2953
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Back Pain - Outcome Measures
Pain Measurement
SF-36 pain scale
Visual analog scale (VAS)
Brief Pain Inventory (BPI)
Treatment Outcomes in Pain Survey (TOPS)
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Back Pain - Outcome Measures
Global Satisfaction
Extremely, very, somewhat satisfied
Mixed
Somewhat, very, extremely dissatisfied
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Back Pain - Outcome Measures
(Optional) General health status
SF-36
Depression
Beck Depression scale
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Back Pain - Outcome Measures
Instruments exist to measure the effect of
drug interventions on chronic back pain for:
function
pain
global satisfaction
general health status
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Chronic Low Back Pain Therapy
- Multimodality
Back exercises - flexion and/or extension
Aerobic exercise
Medications
Counterirritant topical therapiesStress management
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Chronic Low Back Pain - Medications
NSAIDsMuscle relaxants
Analgesics
AntidepressantsAnticonvulsants
Alpha-2 adrenergic agonists
Miscellaneous
NONE ARE INDICATED FOR CHRONIC
LOW BACK PAIN!
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Chronic Low Back Pain -
Medications - NSAIDS Short half-life
acute exacerbations, quick onset
Long half-life
sustained effect
Cox - 2 inhibitors
equal efficacy - decreased toxicity
van Tulder et al: Spine 2000;25:2501-2513
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Chronic Low Back Pain -
Medications - Muscle Relaxants Cyclobenzaprine
Orphenadrine
Metaxolone
Chlorzoxazone
Methocarbamol
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Chronic Low Back Pain -
Medications - Analgesics Nonnarcotic
Acetaminophen
Tramadol
Narcotic
Short acting
Long acting
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Case Study - Chronic Somatic
Pain - Mild To Moderate 52 year old person - work-related
myofascial injury
Treatment regimen Change of NSAID - diclofenac 100mg QD
Maintain methocarbamol 750mg BID
Diclofenac 50mg prn acute exacerbations
maintain exercises program
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Case Study - Chronic Somatic
Pain - Mild to Moderate 67 year old person - facet arthritis
Treatment regimen
Rofecoxib 25mg QD
Cyclobenzaprine 10 mg QHS
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Case Study - Chronic Somatic
Pain - Moderate to Severe 72 year old person - s/p laminectomy with
fractured screw
Treatment regimen Celecoxib 200mg BID
Nortriptyline 50mg QHS
Fentanyl patch 50 mcg
Hydrocodone 5 mg prn
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Case Study - Chronic
Neuropathic Pain - Moderate to
Severe 42 year old person - traumatic neuropathy -
sciatic nerve
Treatment regimen Ketoprofen - long acting - 200mg QD
Gabapentin - 100mg TID
Oxycodone - long acting - 40mg TID
Hydrocodone - 7.5mg PRN
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Chronic Low Back Pain -
Summary Model for chronic pain
Outcome tools are available
Somatic pain is identifiable
Degree of pain - effect on study design
mild to moderate - single drug v. placebo
(active comparator)
moderate to severe - stable multidrug regimen -
flare with withdrawal
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