BACK PAIN - CHRONIC ISSUES

David Borenstein, MD Clinical Professor of Medicine Arthritis and Rheumatism Associates The George Washington University Medical Center Washington, DC

Chronic Low Back Pain

Issues for Discussion 1. Define the forms of chronic low back pain and its 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?)

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

WHAT IS CHRONIC LOW BACK PAIN And ITS PREVALENCE?

LOW BACK PAIN DEFINITION

Pain that occurs in an area with boundaries between the lowest rib and the crease of the buttocks

Chronic Low Back Pain

Duration greater than 3 months Pain that persists longer than the expected time period for healing

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 total disabilities in > 18 yo in 1999 Workers compensation 1986-1996 - > 1 year 8.8% of claims - 64.9%-84.7% of annual costs ___________________________________
CDC. MMWR 2001;50:120-125 Hashemi L et al: J Occup Environ Med 1998;40:1110-1119

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 6 weeks __________________________________________
van den Hoogen et al: Ann Rheum Dis 1998;57:13-19

Low Back Pain - Disorders

Mechanical Rheumatologic Infectious Neoplastic Endocrinologic
(N > 60)

Referred Hematologic Neurologic Psychiatric Miscellaneous

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Borenstein D, Wiesel S, Boden S: Low Back Pain: Medical Diagnosis and Comprehensive Management. 1995

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

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

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

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;2:82-84 Rowe 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

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

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

LOW BACK PAIN DIAGNOSIS

Somatic v. neuropathic v. radicular pains can be differentiated Specific pain generators (individual joint or muscle) are difficult to identify but localization is not essential for effective therapy

Chronic Back Pain - Outcome Measures

Back specific function Pain Patient global satisfaction

Back Pain - Outcome Measures

Back Specific Function
Roland Morris Disability Questionnaire
Oswestry Disability Index

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

Back Pain - Outcome Measures

Oswestry Disability Index - pain and function assessment 10 sections on various functions with 6 levels of assessment Physical and social functions that day Scores added (0-no disability to 100maximum disability) Validated and reproducible instrument _____________________________________
Fairbank J, Pynsent P: Spine 2000; 25:2940-2953

Back Pain - Outcome Measures

Pain Measurement
SF-36 pain scale Visual analog scale (VAS) Brief Pain Inventory (BPI) Treatment Outcomes in Pain Survey (TOPS)

Back Pain - Outcome Measures

Global Satisfaction
Extremely, very, somewhat satisfied Mixed Somewhat, very, extremely dissatisfied

Back Pain - Outcome Measures (Optional)

General health status
SF-36

Depression
Beck Depression scale

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

Chronic Low Back Pain Therapy - Multimodality

Back exercises - flexion and/or extension Aerobic exercise Medications Counterirritant topical therapies Stress management

Chronic Low Back Pain - Medications

NSAIDs Muscle relaxants Analgesics Antidepressants Anticonvulsants Alpha-2 adrenergic agonists Miscellaneous NONE ARE INDICATED FOR CHRONIC LOW BACK PAIN!

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

Chronic Low Back Pain Medications - Muscle Relaxants

Cyclobenzaprine Orphenadrine Metaxolone Chlorzoxazone Methocarbamol

Chronic Low Back Pain Medications - Analgesics

Nonnarcotic
Acetaminophen Tramadol

Narcotic
Short acting Long acting

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

Case Study - Chronic Somatic Pain - Mild to Moderate

67 year old person - facet arthritis
Treatment regimen
Rofecoxib 25mg QD Cyclobenzaprine 10 mg QHS

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

 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

Case Study - Chronic Neuropathic Pain - Moderate to Severe

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