The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia.
Postherpetic neuralgia (PHN) is a painful complication of acute herpes zoster. This multicenter, double-blind, controlled study randomized 299 PHN patients to receive either NGX-4010, a high-concentration capsaicin (8%) patch, or a low-concentration capsaicin (0.04%) control patch for 30, 60, or 90 minutes. The mean percent reductions in NPRS score from baseline to weeks 2 through 8 were significantly greater in the total NGX-4010 group (26.5%, P = .0286) and the 90-minute NGX-4010 group (27.8%, P = .0438) compared to the pooled control group (17.3%). After review of the data suggested a difference between genders in reporting of pain scores and a higher proportion of males (61%) in the 60-minute NGX-4010 group, post hoc gender-stratified analyses were performed and showed that the 60-minute NGX-4010 group also had a significantly larger mean percent reduction in average pain scores (28.0%, P = .0331). Pain reduction in the 30-minute NGX-4010 group, although similar in magnitude to the other doses, was not significantly different from control in either of these analyses. Similar results were observed during weeks 2 through 12. Most treatment-emergent adverse events were application-site specific, transient and mostly mild to moderate in severity. ⋯ This article reports the safety and efficacy of NGX-4010 applied for 3 different durations (30, 60, or 90 minutes) in patients with PHN. The results identified the 60-minute duration as the dose to be evaluated in subsequent studies and identified a gender effect on reported changes in pain.
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Randomized Controlled Trial Comparative Study
Pain and functioning of rheumatoid arthritis patients based on marital status: is a distressed marriage preferable to no marriage?
Relationships may influence adjustment to chronic pain conditions such as rheumatoid arthritis (RA). We examined how both marital status and marital adjustment were related to pain, physical disability, and psychological disability in 255 adults with RA. Among married participants (n = 158), better marital adjustment (assessed using the Locke-Wallace Marital Adjustment Scale) was correlated with less pain and physical and psychological disability (all P values < .05). Married participants were divided into distressed (n = 44) and nondistressed (n = 114) subgroups and compared with unmarried participants (n = 97). Controlling for demographics and disease severity, unmarried participants had higher affective pain (P = .009) and higher psychological disability (P = .02) than only the nondistressed married participants, but unmarried participants did not differ from distressed married participants. These findings suggest that being married in itself is not associated with better health in RA but that being in a well-adjusted or nondistressed marriage is linked with less pain and better functioning. ⋯ This study examined relationships of marital status and marital adjustment to pain and physical and psychological disability in RA. Findings underscore the importance of considering not only marital status but also degree of marital adjustment in RA and may inform clinical interventions in this population.