CHRONIC BACK PAIN:

Is It More Or Less Neuropathic?

Speaker’s Name
Prologue
Neuropathic Pain

Definition
 Pain initiated or caused by a primary lesion or
dysfunction in the nervous system
Examples
 Diabetic Painful Neuropathy
 Post-Herpetic Neuralgia
 Post-SCI Pain
 Multiple Sclerosis
 Cancer-associated neuropathic pain
 Chronic radiculopathies
Mixed / Combined Pain:
More Or Less Neuropathic
 Neuropathic Back Pain
Prevalence & Burden of Illness
7772 patients with various forms of Chronic Low
Back Pain (CLBP) were administered:
 painDETECT Questionnaire (PD-Q)
 Medical Outcomes Study (MOS) sleep scale
 Patient Health Questionnaire (PHQ-9)
 Hannover Functional Ability Questionnaire
painDETECT Questionnaire
Prevalence of Neuropathic CLBP
PD-Q Score

50
% of respondents

40
35.3 37
30
27.7
20
10
0
< / = 12 13 - 18 > / = 19
Neuropathic MonthsAmbiguous,
with neuropathic pain Neuropathic
component neuropathic component
unlikely component likely (> 90%)
(< 15%) may be
present
Prevalence of Neuropathic CLBP
PD-Q Score

50
% of respondents

40
35.3 37
30
27.7
20
10
0
< / = 12 13 - 18 > / = 19
Neuropathic Months Ambiguous,
with neuropathic pain Neuropathic
component neuropathic component
unlikely component likely (> 90%)
(< 15%) may be
present
 Neuropathic Back Pain* & Pain
Intensity
50 43
% reporting severe pain on NRS

40

30
20.4
20

10

0
Non-neuropathic Back Pain Neuropathic Back Pain

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* & Pain
Intensity
50 43
% reporting severe pain on VAS

40

30
20.4
20

10

0
Non-neuropathic Back Pain Neuropathic Back Pain

Neuropathic back pain is more likely to be severe

than non-neuropathic back pain

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* & Sleep
100

80 75.5
% reporting sub-optimal

60 52.2
sleep on MOS

40

20

0
Non-neuropathic Back Pain Neuropathic Back Pain

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* & Sleep
100

80 75.5
% reporting sub-optimal

60 52.2
sleep on MOS

40

20

0
Non-neuropathic Back Pain Neuropathic Back Pain
Neuropathic back pain is significantly more likely to
result in sub-optimal sleep than non-neuropathic
back pain
* Detected using painDETECT questionnaire
 Neuropathic Back Pain* & Mood
Disorders
20
15.4
% of respondants

13

10
3.9
2.2
0
Non-neuropathic Back Neuropathic Back Pain
Pain
Severe Depression Panic/Anxiety Disorder

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* & Mood
Disorders
20
15.4
% of respondants

13

10
3.9
2.2
0
Non-neuropathic Back Neuropathic Back Pain
Pain
Severe Depression Panic/Anxiety Disorder

Neuropathic back pain patients are significantly more

likely to report severe depression or panic/anxiety
disorder than non-neuropathic back pain patients
* Detected using painDETECT questionnaire
 Neuropathic Back Pain* &
Functionality
70 58.9
compared to healthy subject

60
% loss functionality as

50
37.7
40
30
20
10
0
Non-neuropathic Back Neuropathic Back Pain
Pain

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* &
Functionality
70 58.9
compared to healthy subject

60
% loss functionality as

50
37.7
40
30
20
10
0
Non-neuropathic Back Neuropathic Back Pain
Pain
Neuropathic back pain results in significantly greater
decrease in functionality than non-neuropathic
back pain
* Detected using painDETECT questionnaire
 Neuropathic Back Pain* & Medical
Care Sought
50 44.5
% of responders

40
30 25.6

20
10
0
Non-neuropathic Back Pain Neuropathic Back Pain
>/= 3 physician visits in past 4 weeks

* Detected using painDETECT questionnaire

 Neuropathic Back Pain* & Medical
Care Sought

Number of therapists visited

50 2.5 3
% of responders

40 2.5
1.7 2
30
1.5
20
1
10 0.5
0 0
Non-neuropathic Back Pain Neuropathic Back Pain
>/= 3 physician visits in past 4 weeks Number of different therapists

Neuropathic back pain patients report significantly more

physician visits & number of therapists visited than
non-neuropathic back pain patients
* Detected using painDETECT questionnaire
Conclusions

Prevalence of neuropathic component is high in

chronic back pain patients
Neuropathic back pain patients suffer more (and
more severely) than those without neuropathic pain
 Pain intensity
 Sleep disturbances
 Mood disturbances
 Functionality
Neuropathic back pain patients seek more medical
attention than those without neuropathic pain
Identifying Chronic Back Pain Patients
With Neuropathic Component

Screening Questionnaires
What is a Screening Questionnaire

A set of pinpointed questions:

 To promptly identify any characteristic features of

neuropathic pain that the patient might be suffering
from

 Thereby saving the time spent by the practitioner in

determining the presence of these characteristic
features

 Thus facilitate prompt detection of neuropathic pain in

busy practice
 Criteria for Optimal Screening
Questionnaire

Simple, brief, easy to use (ideally only a few items)

Self-administered or clinician-administered
Valid
 Corresponds with NeP diagnosis assigned by an expert
Sensitive
 Probability of positive score in patients with NeP
Specific
 Probability of negative score in patients without NeP
 Available Screening Questionnaires
ID PAIN DN4 for pain LANSS for DN4 for LANSS for
Patients DETECT Patients Physicians Physicians

Questions/
Pain √ √ √ √ √ √
Descriptors

Number of
Questions 6 7 9 7 10 7

Sensitivity/ 0.73/0.55 0.78/0.81 0.85/0.80 0.76/0.68 0.83/0.90 0.83/0.87

Specificity
(cut off (2) (3) (18) (12) (4) (12)
score)

Validated Yes, incl. Mix Doesn’t Yes, incl Mix Doesn’t Yes, Not in Yes, at 1
Pain patients include Mix Pain patients include Mix Mix patients center, not in
patients patients Mix patients

Publication Poster ‘05 J. Pain, ‘05 CMRO, ‘06 J. Pain, ‘05 J. Pain, ‘05 J. Pain, ‘01
(prelim)

Intended Patient Patient Patient Patient Physician Physician

use administered administered administered administered administered administered
 Available Screening Questionnaires
ID PAIN DN4 for Pain LANSS for DN4 for LANSS for
Patients DETECT Patients Physicians Physicians

Questions/
Pain √ √ √ √ √ √
Descriptors

Number of
Questions 6 7 9 7 10 7

Sensitivity/ 0.73/0.55 0.78/0.81 0.85/0.80 0.76/0.68 0.83/0.90 0.83/0.87

Specificity
(cut off (2) (3) (18) (12) (4) (12)
score)

Validated Yes, incl. Mix Doesn’t Yes, incl Mix Doesn’t Yes, Not in Yes, at 1
Pain patients include Mix Pain patients include Mix Mix patients center, not in
patients patients Mix patients

Publication Poster ‘05 J. Pain, ‘05 CMRO, ‘06 J. Pain, ‘05 J. Pain, ‘05 J. Pain, ‘01
(prelim)

Intended Patient Patient Patient Patient Physician Physician

use administered administered administered administered administered administered
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
painDETECT Questionnaire
Validation of painDETECT
Questionnaire
Validation of painDETECT
Questionnaire

Prospective, multi-center study in 411 Chronic Low

Back Pain patients recruited at 10 pain centers in
Germany
PD-Q results validated against diagnoses by 2 pain
specialists working independently
 Sensitivity = 85%
 Specificity = 80%
 Predictive accuracy = 83%
Treating Chronic Back Pain Patients
with Neuropathic Component
Is LYRICA A Drug Of Choice?
Chemical Structure
 Novel Mechanism of Action

LYRICA Binds LYRICA calms hyper-

Here!
excited neurons

MOA

ampton JE, Scott LJ. Drugs 2004; 64: 2813. Huckle R. Curr Opin Investigational Drugs. 2004; 5: 82.
 ‘Clean’ Pharmacokinetic Profile

Frampton JE, Scott LJ. Drugs 2004; 64: 2813. Wesche D, Bockbrader H. J Pain 2005; 6: S29 [Abs]. Data on file. Pfizer Inc.
Unparalleled Clinical
Development Program
Peer Reviewed Publications in
Neuropathic Pain
Peer Reviewed Publications in
Neuropathic Pain
 Meaningful, Rapid & Consistent
Pain Relief
Daily Pain Scores Weekly Pain Scores
* P < 0.01 vs placebo

* P < 0.01 vs placebo

* P < 0.01 vs placebo

Responder Rates

PGIC

Dworkin RH, et al. Neurology 2003; 60: 1274.

 Overall Quality of Life
Improvement

SF-36
questionnaire*

* Pooled analysis of 10
pivotal studies

Data on file, Pfizer Inc.

 Sustained Long-term Efficacy

Tolerance did not develop

No special safety concerns emerged
Portenoy et al. Diabetes 2004; 53 (supp 2): A142 [Abs].
 Favorable Safety Profile
Most commonly reported adverse events*

* Pooled analysis of 10
pivotal studies

†
P<0.05 Pregabalin vs.
placebo

‡
Peripheral edema was not
associated with any fluid
retention or any
cardiovascular, hepatic or
renal abnormality

No clinically important changes in:

• Laboratory investigations (including glucose control)
• ECG, BP, Heart rate
Data on file, Pfizer Inc.
Efficacious in Fibromyalgia
Syndrome
 Efficacious in Fibromyalgia
Syndrome
Significant reduction in pain at 450 mg/day
• Mean pain score on NRS
• Responder rate
• SF-MPQ VAS, total, sensory and affective scores
• 47% decrease in SF-MPQ PPI index
Significant improvement of sleep at 300 and 450 mg/day
• Mean sleep interference score on NRS
• Medical Outcomes Study (MOS) – Sleep measure
Significant improvement in fatigue & global measures of change at
300 & 450 mg/day
• Multidimensional Assessment of Fatigue (MAF) scale
• Patient/Clinician Global Impression of Change (PGIC/CGIC)
Significant improvement in Quality of life at 450 mg/day
• SF-36 scale

Crofford LJ, et al. Arthritis Rheum 2005; 52: 1264.

 Effectively Alleviates Sleep
Disturbances

Mean change in sleep

interference scores in
NeP studies

Effects on sleep architecture

in healthy volunteers

Weekly pain & sleep

interference scores in
OA trial
Freeman R, et al. APS 2006.
Effectively Counters Anxiety

LYRICA effectively counters anxiety in Generalized &

Social Anxiety Disorders (GAD & SAD)
 Effectively Counters Anxiety
LYRICA relieves anxiety associated with neuropathic
pain
POMS Score HADS- A Score

Endpoint POMS
tension-anxiety
Study score P value

Placebo LYRICA

Rosenstock 10.49 8.39 0.02

Lesser NR NR < 0.05

Siddall study

Rosenstock J, et al. Pain 2004; 110: 628; Lesser H, et al. Neurology 2004; 63: 2104; Siddall PJ, et al. Neurology 2006; 67: 1792.
Recommended As 1st Line Drug
By Prestigious Bodies

ADA (2003)
 Diabetic Painful Neuropathy
AAN (2004)
 Post Herpetic Neuralgia
Mayo Clinic (2005)
 Diabetic Painful Neuropathy
EFNS (2006)
 Diabetic Painful Neuropathy
 Post Herpetic Neuralgia
 Central Neuropathic Pain
Epilogue
Neuropathic Back Pain

There is a high prevalence of neuropathic component

in patients suffering from chronic back pain

Screening questionnaires like painDETECT can be

used to facilitate prompt detection of NeP in busy
practice

Burden of suffering is significantly higher in patients

with neuropathic back pain than those with non-
neuropathic back pain

LYRICA is a drug of choice for management of

neuropathic pain disorders
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Cymbalta Prescribing Information. Eli Lilly & Co., USA. 2004.
Dubinsky R. Neurology 2004; 63: 959.
Dworkin R. J Pain 2005; 6: S30 [abs]
Dworkin R. Arch Neurol 2003; 60: 1524.
Dworkin R. Neurology 2003; 60: 1274.
Finnerup N. Pain 2005; 118: 289.
Frampton JE. Drugs 2004; 64: 2813.
Freynhagen R. Curr Med Res Opin 2006; 22: 1911.
References

Freynhagen R. Curr Med Res Opin 2006; 22: 529.

Freynhagen R. Pain 2005; 115: 254.
Gilron I. Can Med Assoc J 2006; 175: 205
Huckle R. Curr Opin Investigational Drugs. 2004; 5: 82.
Lesser H. Neurology 2004; 63: 2104.
LYRICA Prescribing Information. Pfizer India. 2007.
Neurontin Prescribing Information. Pfizer Inc., USA. 2004.
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Rice A. Pain 2001; 94: 215.
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Thank You