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Human Experimental Pain Models
Author Bios
Learning Objectives
Clinical Significance and Phenomenology
Complex Diseases: Need to Simplify
Model Requirements
Brief and Sustained Experimental Pain
Choice of the Pain Stimulus
A Model Design for Pain Experimentation
Experiential Adjustment
Choice of Stimulation Site
Stimulation Site for a Study of TMJD
Currently selected section: Experimental Design
Model Validation: Level 1
Model Validation: Level 2
Model Validation: Level 3
Model Validation: An Example
Cross-Validation with Other Model Systems
Model Systems as Tools
Sample Size Estimation
Potential Difficulties
Conclusion

 

Chapter 21: Human Experimental Pain Models: Experimental Design
        

Subjects vary widely in non-specific effects of pain (e.g. anticipation of pain) as well as the previously-mentioned sensitivity to and suppression of pain, which are complexly controlled traits. Experimenters should therefore consider, whenever feasible, using a randomized and counterbalanced crossover design in which both treatments (hypertonic and isotonic saline) are applied to each individual, so that each subject forms his or her own control. In other words, except for the order and time, the "pain group" and the "control-group" are identical (See Chapter 6).

Subjects should know that one of the two infusions causes pain. However, they should be blinded with respect to what solution is infused. Infusion rates for isotonic saline should be based on the average infusion profile required to produce pain of target intensity at the given application site to produce similar volumetric conditions for both pain and the saline-control trial.

With pain being induced and sustained by the continuous infusion of hypertonic saline, the investigator studies the alternatives to the null hypotheses (H0) that the experientially-adjusted rate of infusion of hypertonic saline and the resulting graded experience of pain cause the hypothesized outcome. Grading of pain is required in order to permit comparison of mean phenotypic values for a given intensity of pain. The experiential titration of the stimulus, such as keeping subjects at similar pain intensities, is useful for the comparative study of response behaviors of subjects with particular genotypes or significantly different phenotypes.

Figure 11.1: Subject in Pain
Photograph of a woman in pain, described in text.

First Frame of Quicktime movie (not linked).

Movie shows subject in pain induced by the intramuscular infusion of the algesic substance into the jaw muscles.


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