The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
Pregabalin for postherpetic neuralgia: placebo-controlled trial of fixed and flexible dosing regimens on allodynia and time to onset of pain relief.
Time to onset of pain relief and improvement in allodynia in 269 patients with postherpetic neuralgia was examined in a 4-week randomized trial comparing flexibly dosed pregabalin (150-600 mg/d), fixed-dose pregabalin (300 mg/d), and placebo. For each patient with clinically meaningful pain reduction (>or=30%) at end point, onset of pain relief was defined as the first study day on which a patient reported >or=1-point reduction in pain relative to baseline. Average dose achieved was 396 mg/d in the flexible-dose group compared with 295 mg/d in the fixed-dose group. Median pain relief onset times were 3.5 days (flexible-dose), 1.5 days (fixed-dose), and >4 weeks (placebo). Compared with placebo, significantly more patients in both pregabalin treatment groups achieved >or=30% and >or=50% pain reduction at end point. Almost 95% of patients had brush-evoked allodynia, with 68% having moderate to severe allodynia (>or=40/100 mm). At baseline, pain and allodynia were highly correlated. Independent of treatment assignment, improvement in pain and improvement in allodynia were significantly correlated. Allodynia could serve as a useful surrogate outcome measure in future studies. Pregabalin was significantly better than placebo in alleviating allodynia (flexible-dose reduction, 26 mm; fixed-dose, 21 mm; placebo, 12 mm). Discontinuation rates due to adverse events were more frequent in the fixed-dose group. ⋯ A flexible-dose regimen reduces discontinuations, facilitates higher final doses, and results in a slightly greater pain relief. Allodynia (touch-evoked pain) can be of disabling severity and is present in nearly all patients with postherpetic neuralgia. Allodynia severity is correlated with pain severity and improvement in allodynia is correlated with clinical response.
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Multicenter Study
Trends in use of opioids by noncancer pain type 2000-2005 among Arkansas Medicaid and HealthCore enrollees: results from the TROUP study.
Use of prescription opioids for noncancer pain has increased significantly in recent years, but it is not known if trends differ among the most common noncancer pain conditions. We examined trends in opioid prescribing for the years 2000 through 2005 for individuals with arthritis/joint pain, back pain, neck pain, and headaches by type and number of pain diagnoses, using data from claims records from 2 health insurers: HealthCore commercially insured members (N = 3,768,223) and Arkansas Medicaid (N = 127,866). Rates of headache, back pain, and neck pain diagnoses increased significantly in Arkansas Medicaid enrollees but more modestly among HealthCore enrollees. Rates of opioid use increased in both groups, with long-term use (>90 days' supply per year) increasing at twice the rate of any use. Rates of opioid use did not differ widely between noncancer pain conditions, but long-term opioid use rates doubled with each additional pain diagnosis. Mean days supply and cumulative yearly dose increased between 2000 and 2005 for all pain types and with increasing number of pain diagnoses, but dose per day supply remained relatively stable. The greatest increases in dose among all the pain conditions were seen in short-acting DEA Schedule II opioids. ⋯ This study demonstrates increased use of opioids, particularly long-term use, in noncancer pain over a 6-year period among those with multiple pain types. These results appear to reflect a general increase in use of prescription opioids for noncancer pain rather than a condition-specific change in prescribing practices.
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Multicenter Study Comparative Study
Common chronic pain conditions in developed and developing countries: gender and age differences and comorbidity with depression-anxiety disorders.
Although there is a growing body of research concerning the prevalence and correlates of chronic pain conditions and their association with mental disorders, cross-national research on age and gender differences is limited. The present study reports the prevalence by age and gender of common chronic pain conditions (headache, back or neck pain, arthritis or joint pain, and other chronic pain) in 10 developed and 7 developing countries and their association with the spectrum of both depressive and anxiety disorders. It draws on data from 18 general adult population surveys using a common survey questionnaire (N = 42,249). Results show that age-standardized prevalence of chronic pain conditions in the previous 12 months was 37.3% in developed countries and 41.1% in developing countries, with back pain and headache being somewhat more common in developing than developed countries. After controlling for comorbid chronic physical diseases, several findings were consistent across developing and developed countries. There was a higher prevalence of chronic pain conditions among females and older persons; and chronic pain was similarly associated with depression-anxiety spectrum disorders in developed and developing countries. However, the large majority of persons reporting chronic pain did not meet criteria for depression or anxiety disorder. We conclude that common pain conditions affect a large percentage of persons in both developed and developing countries. ⋯ Chronic pain conditions are common in both developed and developing countries. Overall, the prevalence of pain is greater among females and among older persons. Although most persons reporting pain do not meet criteria for a depressive or anxiety disorder, depression/anxiety spectrum disorders are associated with pain in both developed and developing countries.
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Randomized Controlled Trial Multicenter Study
A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia.
The purpose of the study was to assess the efficacy and safety of pregabalin monotherapy in patients with fibromyalgia in a randomized, double-blinded, placebo-controlled trial. After 1 week of single-blinded administration of placebo, 750 patients meeting American College of Rheumatology criteria for fibromyalgia were randomly assigned to pregabalin (300 mg/d, 450 mg/d, 600 mg/d) or placebo, administered twice daily for 14 weeks. The primary outcome variable was comparison of end point mean pain scores, derived from daily diary ratings of pain intensity (0 to 10 scale), between each of the pregabalin groups and the placebo group. If positive, additional primary efficacy parameters included the Patient Global Impression of Change (PGIC) and the Fibromyalgia Impact Questionnaire (FIQ) total score. Compared with placebo-treated patients, mean changes in pain scores at the end point in pregabalin-treated patients were significantly greater (P < .001: 300 mg/d, -0.71; 450 mg/d, -0.98; 600 mg/d, -1.00). Compared with placebo, significantly more pregabalin-treated patients reported improvement on PGIC (P < .01 for all 3 pregabalin doses) and significant improvements in total FIQ score for the 450 mg/d (P = .004) and the 600 mg/d (P = .003) doses. Compared with placebo, all 3 doses of pregabalin were associated with significant improvement in sleep. The most commonly reported pregabalin-related adverse events were dizziness and somnolence, which tended to be dose-related. ⋯ This randomized, placebo-controlled trial of 300, 450, and 600 mg/d of pregabalin monotherapy demonstrated that all 3 doses were efficacious for up to 14 weeks for the treatment of fibromyalgia and were well tolerated by most patients. These results provide evidence that pregabalin is an important treatment option for patients with fibromyalgia.
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Randomized Controlled Trial Multicenter Study
Treatment of patients with complex regional pain syndrome type I with mannitol: a prospective, randomized, placebo-controlled, double-blinded study.
To assess the effects of intravenous administration of the free radical scavenger mannitol 10% on complaints associated with complex regional pain syndrome Type I (CRPS I), a randomized, placebo-controlled, double-blinded trial was performed. Forty-one CRPS I patients according to the Bruehl et al diagnostic criteria, were included in 2 outpatient pain clinics of 2 university medical centers and randomly assigned to receive either 10% mannitol iv in 1 L 0.9% NaCL in 4 hours for 5 consecutive days or equal volumes of 0.9% NaCL (placebo). Patients in both groups received physical therapy according to protocol and rescue pain medication if required. Complaints on impairment and disability level and quality of life were assessed up to 9 weeks after baseline, with primary measurement points at 2, 6, and 9 weeks. Monitoring of pain using the visual analogue scale took place continuously during the course of the trial. Except for a significant improvement on a subscale of the Jebsen-Taylor hand function test, no significant differences were found between mannitol and placebo treatment. Changes in both groups in the course of the trial were small and clinically irrelevant on all measurement indices. We conclude that intravenous administration of 10% mannitol is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS I. Whether 10% mannitol can provide beneficial effects for subgroups of CRPS I patients with a pathophysiological profile more closely fitting the presumed mode of action for this intervention remains to be established. ⋯ This article addresses the efficacy of the intravenous administration of the free radical scavenger mannitol for treatment of CRPS type 1. This intervention is not more effective than placebo in reducing complaints for CRPS I patients and provides no addition to already-established interventions for CRPS I.