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Chronic Pain. Lee S. Simon, MD Division Director Analgesic, Anti-inflammatory and Ophthalmology Drug Products ODEV, CDER, FDA. PAIN. Pain is always a subjective experience Everyone learns the meaning of “pain” through experiences usually related to injuries in early life

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chronic pain
Chronic Pain
  • Lee S. Simon, MD
  • Division Director
  • Analgesic, Anti-inflammatory and Ophthalmology Drug Products
  • Pain is always a subjective experience
  • Everyone learns the meaning of “pain” through experiences usually related to injuries in early life
  • As an unpleasant sensation it becomes an emotional experience
  • Pain is a significant stress physically, emotionally
  • In one hundred years there has been clear progress in the field: defining painful disease states and syndromes along with delineating appropriate therapy as shown by a comparison of the Merck Manual in 1999, the Centennial Edition, with the indices for pain and analgesics in the original MerckManualpublished in 1899.
Acetanilid, Acid, Carbolic. Aconite. Aconitine_ Ammonium Iodide. Atropine. Belladonna. Camphor, Monobromated. Camphor‑phenol. Cannabis Indica. Chloroform, Chloral Hydrate. Chloral‑Camphor.





Ethyl Chloride spray.






Merck Manual 1899




Manganese Dioxide.


Methyl Chloride Spray.






Potassium Cyanide


Solanine: In gastric pain.




INDICATIONS.Pain.‑See also, AfterPains, Anesthesia, Boils, Chest Pains, Colic, Gastralgia, Headache, Hepatalgia, lnflammat i o n , Lumbago, Myalgia, Neuralgia, Neuritis. Odontalgia, Otalgia, Ovarian Neuralgia, Rheumatisrn, etc. Also lists of Analgesics, Anesthetics and Narcotics

Pain,13571, 1363-1374 (see also Neuralgia)

abdominal, 257-261, 259t, 260t (see psychogenic, 1363, 1373-1374, 1511 (also Abdomen, pain in)

in pulmonary embolism, 1602

acute, 1363

radicular, 1488-1489

in acute intermittent porphyries, 190 rectal, 339

in angina pectoris, 1663 shoulder, 478-479, 507

with aortic dissection, 1602 somatogenic, 1363

in appendicitis, 265 stump, 1371-1372

in avascular necrosis 453-454 in subacute thyroiditis, 97

in ball of foot, 488-489

testicular, 1805

Merck Manual 1999 Centennial Edition

bladder, 1805

after tooth extraction, 770

cancer, 979 1371 treatment of

in carcinoid tumor, 217

acupuncture for, 2495

cardiac., 1601-1602

cervical traction for, 2495

in carpal tunnel syndrome, 1492-1493 cold for, 2495

chest, 516-517 (see also Chest, pain in) in dying patient, 2510-2511

in cholelithiasis, 401

electrical stimulation for, 2495

chronic, 1363

heat for, 2494-2495, 24941

dental, 746, 760, 769-770

massage for, 2495

in dying patient, 2510-2511

nondrug analgesic approaches in,

ear, 667-668, 667t, 6681 1370, 1370t

evaluation of, 1363-1364

nonopioid analgesics in,1364-1365,

eye, 703 1364t

face, in trigeminal neuralgia, 1457, 1460

opioid analgesics in, 1365-1370,

' in fibromyalgia, 481 - 1366t-1368t

foot, 482-489 during rehabilitation, 2493-2497,

gastrointestinal (see Abdomen, pain in) 2494t

head (see Headache) vulvar, 1947

heel, 485-488 painful fat syndrome 1798

in hemophilia, 912 Paint, poisoning with, 2635t

hip, in children, 2403 Paint thinner, poisoning with,

kidney, 1804-1805 in children,2280-2281

lower back, 475-478

sports-related, 503-505, 5041

menstrual, 1933 hyperplasia of, 753t

'in metatarsophalangeal joints, 488-489

in myocardial infarction, 1669

in myocardial ischemia, 1601-1602

Pallidotomy, 1469

myofascial, 481, 774-775

neck, 474-475 abscess of, 495

neuropathic, 1363, 1371-1373
  • fibromatosis of (Dupuytren's contracture)
  • nociceptive, 1363 t, 491
  • in obstructive uropathy, 1827
  • in osteoarthritis, 451
  • patellofemoral, 501-502, 502f, 503t
  • pelvic, 1944-1948, 1945t
  • pericardial, 1602 1456-1457, 1458t
merck manual 1999 index for analgesics

in acute post-operative pain, 1370-1371

in cancer pain syndromes, 1371

in dying patient, 2510‑2511

in elderly, 2602t; 26041, 2610

fetal effects of, 2024

for labor, 2028

in migraine, 1377, 1377t

nephrotoxicity of, 1878, 1880t, 1881,1882t

in neuropathic pain syndromes, 1371‑1373

nonopioid drugs for, 1364-1365, 1364t

NSAIDs for, 13641365, 1364t

opioid drugs for, 1365-1370,-1366t,1368t

in tension headache, 1378

Merck Manual 1999: Index for Analgesics
However far we have come in furthering our description of disease states, as you can see many of the drugs used 100 years ago remain the drugs we use today:
    • opiates
    • NSAIDs
    • sedatives
    • muscle relaxants
various descriptors of pain
Various Descriptors of Pain

Somatic pain:caused by the activation of pain receptors in either the cutaneous (the body surface) or deeper tissues (musculoskeletal tissues).

Visceral pain: pain that is caused by activation of pain receptors from infiltration, compression, extension or stretching of the thoracic, abdominal or pelvic viscera (chest, stomach and pelvic areas).

Neuropathic pain: caused by injury to the nervous system either as a result of a tumor compressing nerves or the spinal cord, or cancer actually infiltrating into the nerves or spinal cord.

various descriptors of pain1
Various Descriptors of Pain
  • Mild: ??
  • Moderate: ??
  • Severe: ??
    • Although descriptive, does not provide rigor: perhaps these should be used to modify acute and chronic pain indications to allow patients to understand, but how do you measure what is mild, moderate, severe: ultimately it is the bias of the agency, investigators, sponsors to suggest which is which.
various descriptors of pain2
Various Descriptors of Pain
  • Acute pain: short-lasting and manifesting in objective ways that can be easily described and observed. It may be clinically associated with diaphoresis and tachycardia. It can last for several days, increasing in intensity over time (subacute pain), or it can occur intermittently (episodic or intermittent pain). Usually related to a discreet event for onset: post op, post truama, fracture, etc
  • Chronic pain: Long-term and typically defined if it lasts for > three months. It is more subjective and not as easily clinically characterized as acute pain and is more psychological. This kind of pain usually affects a person's life, changing personality, their ability to function, and their overall lifestyle.
various descriptors of pain3
Various Descriptors of Pain
  • General pain:
    • Has been broadly used in the past (92 Pain guidance); however, acute and chronic indications use different models, may be mechanistically different, and have different safety issues. Furthermore, the psychological component clearly separates the acute pain experience from a chronic one.
Chronic pain has a psycho-social component that must be dealt with before depression becomes a part of the clinical picture. Chronic pain should be recognized as a multi-factorial disease state requiring intervention at many levels.
  • A.G. Lipman, Cancer Nursing, 2:39, 1980 (6).
dimensions of chronic pain
Dimensions of Chronic Pain



Social Factors




Psychological Factors

Pathological Process


A.G. Lipman, Cancer Nursing, 2:39, 1980

trial design
Trial Design
  • Looking for models or disease states
    • Osteoarthritis
    • Chronic low back pain
    • Fibromyalgia
    • Neuropathic pain
      • Diabetic neuropathy, amyotrophy
    • Cancer pain
    • Temperomandibular pain
    • Peripheral vascular disease
  • Mechanisms or “mechanistic” approaches
trial design1
Trial Design
  • Possible indications
    • For one disease or model
      • An example: Signs and symptoms of OA
        • Two replicate randomized and controlled trials
        • Three co-primary outcomes at which each must win
          • Pain, function and patient determined global
          • Superiority to placebo, or….
          • Superiority to active comparator
trial design2
Trial Design
  • Possible indications
    • For an organ system
      • For example: improvement in pain of the musculoskeletal system
        • Three models or diseases
          • Low back pain
          • Osteoarthritis
          • Fibromyalgia
        • Need two replicate RCT’s for each model or disease
        • Need three co-primary outcomes pain, function and patient determined global: each must win as either superior to placebo, superior to active comparator
        • The label will also reflect approval of all diseases/models studied
trial design3
Trial Design
  • Possible indications for example: Chronic pain
      • Requires three models, disease states, mechanisms
        • Replicate trials in each model, should be in disparate diseases (eg: musculoskeletal, cancer, neuropathic)
        • Must measure pain, patient global, and some functional outcome
        • Must be superior to placebo in all three outcomes, superior to active comparator
        • Label will reflect approval for the broad category: limited by safety considerations
        • Label will thus, based on data, demonstrate that therapy is approved for the indication of chronic pain but also the three diseases/models studied
trial design4
Trial Design
  • Mechanistic approach
    • Don’t know YET how to do this
    • Don’t really know the models
    • Possible examples:
      • Alteration of “wind-up” by inhibition of NMDA receptors
      • Alteration of “brain plasticity”
      • Alteration of early markers that predict specific and verified CLINICAL outcomes