Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .
A randomized, multicenter, double-blind, placebo-controlled, dose-finding study of ORG 2766 in the prevention or delay of cisplatin-induced neuropathies in women with ovarian cancer.
OBJECTIVE The objective was to evaluate the efficacy of Org 2766 ( a hexapeptide analogue of ACTH ) in the prevention or delay of cisplatin-induced neuropathy during chemotherapy in women with ovarian cancer as measured by vibration perception threshold ( VPT ) . METHODS In this r and omized , multicenter , double-blind , placebo-controlled study , 196 women with ovarian cancer were treated with cisplatin 75 - 100 mg/m2 , cyclophosphamide 600 - 1000 mg/m2 plus placebo or two dose levels of Org 2766 . The cisplatin-induced neuropathies were monitored by determining the  VPT with the Vibratron II .  VPT was determined for both the most sensitive great toe and the index finger on a monthly basis during treatment and months 1 , 2 , and 3 postchemotherapy . Once the blind was broken , it was found that 174 women ( 59 in placebo , 58 in 2 mg , and 57 in 4 mg ) had enough data to allow evaluation . RESULTS Over the course of follow-up , the VPT was found to increase . This is consistent with the development of cisplatin-induced peripheral neuropathies . The baseline VPT for the index finger was less than that of the great toe ( 0.65 vs 2.13 ) , but the percentage change in VPT was the same for both ( percentage increase in VPT of about 350 % ) . When the VPTs are compared according to the dose of Org 2766 given , there appears to be no difference in the rate of change or degree of neuropathies that developed in these women receiving cisplatin and cyclophosphamide . CONCLUSIONS The development of cisplatin-induced neuropathies is confirmed by measurement of the VPT . The rate of development of neuropathies seems to accelerate after the sixth course of cisplatin . When the development of neuropathies is evaluated on the basis of Org 2766 dosage , it is found that there is no difference in the rate or degree of neuropathies seen . Instead of providing protection from and delay of onset of peripheral neuropathies caused by cisplatin , these results suggest that the administration of Org 2766 appears to cause an increase in the rate of change and degree of neuropathies ( P > 0.05 )
Such interventions would have the potential to reduce the prevalence of chronic pain in the population .
Although certain risk factors can identify individuals who are most likely to develop chronic pain , few interventions to prevent chronic pain have been identified .
To facilitate the identification of preventive interventions , an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain .
We present general design considerations for prevention trials in population s that are at relatively high risk for developing chronic pain .