Table 2.
Variable | Nerve fibers involved | ARA 290 (n = 21) | Placebo (n = 17) | ||
---|---|---|---|---|---|
|
|
||||
Change | Number of patients (%) | Change | Number of patients (%) | ||
Cold detection threshold | Aδ and C | Decrease | 19 (91) | Decrease | 11 (65) |
Warm detection threshold | Aδ and C | Decrease | 17 (81) | Decrease | 13 (77) |
Increase | 1 (5) | ||||
Thermal sensory limen | Aδ and C | Decrease | 4 (19) | Decrease | 4 (24) |
Increase | 2 (10) | ||||
Paradoxical heat sensation | Aδ | Decrease | 8 (38) | Decrease | 7 (41) |
Cold pain threshold | Aδ and C | Increase | 3 (14) | — | 0 |
Heat pain threshold | C | Decrease | 3 (14) | Decrease | 1 (6) |
Increase | 5 (24) | ||||
Mechanical detection threshold | Aβ | Decrease | 11 (52) | Decrease | 10 (59) |
Mechanical pain threshold | Aβ | Decrease | 11 (52) | Decrease | 4 (24) |
Increase | 4 (19) | Increase | 2 (12) | ||
Mechanical pain sensitivity | Aβ + C | Decrease | 2 (10) | Decrease | 1 (6) |
Increase | 5 (24) | ||||
Dynamic mechanical allodynia | Aβ | Increase | 11 (52) | Increase | 3 (18) |
Windup ratio | Aδ and C | Increase | 4 (19) | Increase | 2 (12) |
Vibration detection threshold | Aβ | Decrease | 20 (95) | Decrease | 15 (88) |
Pressure pain threshold | Aδ and C | Decrease | 3 (14) | Decrease | 1 (6) |
Increase | 10 (48) | Increase | 7 (41) |
Patients in the ARA 290 and placebo groups showed functional impairment of both small nerve fibers (Aδ and C) as well as larger sensory nerve fibers (Aβ). Data are expressed as number of patients deviating beyond the 95% confidence interval of a sex- and age-matched normal population. Test sites of face, hand and foot are pooled for calculation of percentages. “Decrease” indicates a loss of function; “Increase” indicates a gain in function compared with a normal population. For example, a decreased CDT means that a patient required a lower temperature stimulus than normal to determine that an object was cold (that is, a decrease in sensitivity).