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Trial Design: Pain Sections
Author Bio
Currently selected section: Introduction
Placebo Effects
Single Dose Trials
Repeated Dose Trials
Explanatory Versus Pragmatic
Dose-Response
Parallel Group Versus Crossover
Conclusion
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chapter 1: Clinical Trials of Pain Treatment: Introduction
          

SOME FUNDAMENTAL QUESTIONS ABOUT CLINICAL TRIALS OF TREATMENTS FOR PAIN (CONTINUED)

In terms of underlying mechanisms, is pain one or many? For example, will a clinical trial finding that a new drug relieves postoperative pain or diabetic neuropathy pain generalize to pain arising in different tissues or from different disease processes?

This is one of the most controversial issues in pain research and will remain so until more types of pain have been rigorously studied with many classes of analgesics. Basic scientists have demonstrated many different pain mechanisms, some unique to particular disease models and some shared across many models (see Yaksh et al., 1999 and accompanying symposium papers).

The splitters' arguments: The top panel in Figure 1.1 (from Woolf and Mannion, 1999) shows "normal" sensory function in undamaged tissue.

Figure 1.1: Stimulus independent pain showing Normal sensory fuinction, and sensory function after nerve injury

Brief application of a noxious stimulus like heat or pinprick causes small nerve fibers ("nociceptors") to discharge. These impulses are carried to the fibers' central termination in the dorsal horn of the spinal cord, and excite dorsal horn neurons that can carry information to the brain. Diseases that injure nerve introduce several additional unique pain mechanisms. The middle panel shows that injured nerve fibers accumulate additional sodium channels and alpha adrenoreceptors. In the absence of peripheral stimulation, sodium currents that enter the cell via the new channels and stimulation of the new adrenoreceptors by circulating catecholamines can cause spontaneous nerve discharge and ongoing pain. The bottom panel shows that after nerve injury, spinal cord dorsal horn pain signalling neurons may begin to discharge spontaneously. Studies in animal models of nerve injury suggest unique effectiveness of drugs that block the new sodium or adrenergic channels on injured nerve fibers or that inhibit spontaneous discharge of spinal neurons.

To take another example of mechanistic splitting, scientists, studying pain arising in hollow viscera, have claimed that these pain syndromes may have mechanistic features distinct from pain arising in bone, joint, skin, or soft tissues, including a particularly high content of peptide neurotransmitters in visceral nociceptors (Levine et al., 1993), transmission of visceral pain information via the spinal cord's dorsal column postsynaptic tract (Willis et al., 1999), and reduction in visceral pain by peripheral application of kappa receptor opioids to the organ (Sengupta et al., 1999).

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