The journal of pain : official journal of the American Pain Society
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Multicenter Study Clinical Trial
Initial Psychometric Properties of the Pain Care Quality Survey (PainCQ).
This study examined the psychometric properties of the Pain Care Quality (PainCQ) survey, a new instrument to measure the quality of nursing and interdisciplinary care related to pain management. Hospitalized medical/surgical oncology patients with pain from 3 states completed the 44-item version of the PainCQ survey following completion of a nursing shift. Interdisciplinary items were evaluated over the entire hospital stay; nursing care was evaluated during the previous shift. The sample included 109 patients ranging in age from 20 to 84 (mean = 53.09). The sample was 58.7% female, 88% non-Hispanic white. Principal Axis Factoring with an oblimin rotation was used as factors were correlated. Two scales resulted. The PainCQ-Interdisciplinary scale included 11 items representing 2 constructs and explaining 47.1% of shared item variance: partnership with the health care team (k = 6 items; α = .85) and comprehensive interdisciplinary pain care (k = 5 items; α = .76). The PainCQ-Nursing scale measured three constructs and explained 60.8 % of shared item variance: being treated right (k = 15 items; α = .95), comprehensive nursing pain care (k = 3 items; α = .77), and efficacy of pain management (k =4 items; α = .87). Results supported the internal consistency reliability and structural validity of the PainCQ survey with 33 items. ⋯ This article presents the psychometric properties of a new tool to measure interdisciplinary and nursing care quality related to pain management from the patient's perspective. This tool can be used for research and as a clinical performance measure to monitor and improve quality of care and patient outcomes.
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Randomized Controlled Trial Multicenter Study
Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial.
This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of ≥ 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either ≥ 30% or ≥ 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P ≤ .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients. ⋯ This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP.
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Multicenter Study
Predictors of postherpetic neuralgia among patients with herpes zoster: a prospective study.
Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ). The main objectives of this study were to: 1) estimate the severity and duration of PHN; and 2) identify the predictors of PHN. From October, 2005 to July, 2006, 261 outpatients with HZ, aged ≥ 50, were recruited within 14 days of rash onset during the routine clinical practice of 83 physicians across Canada. Physicians documented HZ characteristics, treatments, general health, functional, and immune status. HZ pain was measured at recruitment and on days 7, 14, 21, 30, 60, 90, 120, 150, and 180 following recruitment. PHN was defined as a worst pain ≥ 3 persisting or appearing more than 90 days after rash onset. Predictors of PHN were obtained by hierarchical log-binomial regression. Twenty-two percent of 249 immunocompetent subjects with HZ developed PHN. Median duration of PHN was 77 days. Independent predictors of PHN included: older age, limitation in performing usual activities prior to HZ, and pain severity at recruitment. This study confirms that older age and greater acute pain severity are predictors of PHN, while functional status emerges as a novel independent predictor of PHN that deserves further exploration. These findings will contribute to optimal use of the HZ vaccine and testing of new therapies that might prevent PHN. ⋯ This study confirmed that older age and greater acute pain severity are robust predictors of PHN, whereas functional status emerged as a novel predictor. Despite the high proportion of subjects treated with antivirals, the burden of PHN remains considerable, suggesting that prevention and additional early interventions are needed to reduce the burden of HZ.
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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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This study investigated the association between effectiveness of ED pain treatment and race of patients, race of providers, and the concordance of patient and provider race, with a prospective, multicenter study of patients presenting to 1 of 20 US and Canadian EDs with moderate to severe pain. Primary outcome is a 2-point or greater reduction in pain intensity, measured with an 11-point verbal scale, considered the minimum clinically important reduction in pain intensity. A total of 776 patients were enrolled. The sample included 57% female, 44% white, 26% black, and 26% Hispanic. The physician was white in 85% of encounters. Arrival pain score (adjusted odds ratio, 1.14; 95% CI 1.06, 1.24), receipt of any ED analgesia (1.59; 95% CI 1.17, 2.17), and physician nonwhite race (1.68; 95% CI 1.10, 2.55) were significant predictors of clinically significant reduction in pain intensity in multivariate analysis. Nonwhite physicians achieved better pain control without using more analgesics. Future research should explore the determinants of this difference in patient response to pain treatment related to provider race including provider characteristics and training that were not measured in this study. This study provided no evidence supporting an effect of racial concordance on the primary outcome. ⋯ This article presents analysis of predictors of clinically important reduction in pain intensity among emergency department patients, finding nonwhite physicians achieving better pain relief with less analgesia. This finding should encourage researchers to investigate elements of the therapeutic relationship that may be enhanced to achieve better pain relief for patients.