- Email: [email protected]
311 VALIDATION OF S-LANSS SCORE FOR IDENTIFICATION OF NEUROPATHIC PAIN IN PATIENTS FROM NOTHERN TURKEY
Posters / European Journal of Pain Supplements 4 (2010) 47–146
to a change in score of −1.64-points (95% confidence interval, −1.86 to −1.43). Results from subgroup analyses (≥30% or ≥50% pain responders, pregabalin or placebo treatment) were generally consistent with the results from the overall sample, suggesting robustness of findings. Conclusions: Changes in pain levels during treatment with pregabalin were associated with changes in sleep, function, anxiety, and depression. Additional confirmatory studies are encouraged. 309 PREGABALIN IN POST-TRAUMATIC PERIPHERAL NEUROPATHIC PAIN: EFFICIENT ASSESSMENT OF EFFICACY IN A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER STUDY T. Jenkins1 , T. Smart1 , F. Hackman1 , C. Cooke1 , K. Tan1 , R. Cheung2 . 1 Pfizer Global Research and Development, Sandwich, UK; 2 Pfizer, Inc, New York City, NY, USA Introduction: Pregabalin has demonstrated efficacy in several neuropathic pain states, including post-traumatic peripheral neuropathic pain (PTNP), in classic, parallel group trials. A crossover design may be a more efficient method to detect the efficacy of pregabalin. Objectives: To assess the ability of a two-period crossover study design to detect the efficacy of pregabalin in patients with PTNP. Methods: Twenty-five adults (20–70 years) with PTNP for ≥3 months and an average daily pain score ≥4 (0–10 scale) during 1-week single-blind, placebo run-in, were randomised to one of two treatment sequences of pregabalin 300 mg/day vs. placebo. Each treatment period was 2 weeks separated by a 2-week washout, during which patients received placebo. The primary endpoint was the average pain score over the last 7 days on treatment. A mixed effects analysis of covariance was fitted, accounting for period and treatment effects, random subject effect, and baseline incorporated as a covariate. Results: The mean baseline pain score was 6.0 for Period 1 and 5.3 for Period 2 in both sequences. The mean (90% CI) difference between pregabalin and placebo was −0.81 (−1.34, −0.28). The improvement with pregabalin was of similar magnitude to a larger parallel group study in PTNP. Pregabalin was well tolerated, with 2 discontinuations. Somnolence and dizziness were reported in 3 and 6 patients while on pregabalin treatment, respectively. Conclusions: This two-period crossover study detected treatment efficacy of pregabalin in PTNP with a sample size much smaller than parallel-group studies. Such study designs may be useful for proof-of-concept studies. 310 PREVALENCE AND RISK FACTORS FOR PERIPHERAL NEUROPATHIC PAIN IN PATIENTS WITH NEWLY DIAGNOSED TYPE 2 DIABETES N. Tentolouris, C. Voulgari, E. Diakoumopoulou, S. Liatis, K. Kyriakopoulos, N. Katsilambros. 1st Department of Propaedeutic Medicine, Laiko General Hospital, Athens University Medical School, Athens, Greece Introduction: Hyperglycemia is a major permissive factor for the development of diabetic neuropathy, but evidence has emerged suggesting that other factors play a paramount role for its pathogenesis and clinical phenotype. However, prevalence and risk factors for peripheral neuropathic pain (PNP) in patients with newly diagnosed type 2 diabetes (T2DM) are not known. Objectives: The aim of the present study was to determine the prevalence and risk factors for painful neuropathy among subjects with newly diagnosed T2DM without micro- or macrovascular complications. Methods: The study included 203 subjects (98 females/105 males, age 56.5±9.1 years) from the Diabetic Outpatient Clinics of our Hospital. Presence or absence of PNP was determined by the Michigan Neuropathy Screening Instrument (MNSI) using its painrelevant questions and an examination cutpoint >2. Ankle-brachial-
89
pressure-index (ABI) and left-ventricular-mass index (LVMi) were assessed by ultrasonography. Results: The prevalence of PNP was 31.0% in the studied population. Multivariate logistic regression analysis demonstrated that the odds (OR, 95% confidence intervals) of PNP increased with age [1.130 (1.034–1.235)], obesity [2.362 (1.534–3.608)], central fat distribution [1.867 (1.780–1.963)], high systolic blood pressure [1.008 (1.006– 1.118)], fasting glucose [1.012 (1.000–1.204)], and low ABI [1.047 (1.014–1.081)] (all P < 0.05). Additional variables included in the model were HbA1c, LDL-cholesterol, urinary albumin-excretionratio, and LVMi. Conclusions: PNP is common at the time of diagnosis of T2DM. Obesity, central fat distribution, high fasting glucose and peripheral arterial disease are associated with PNP. 311 VALIDATION OF S-LANSS SCORE FOR IDENTIFICATION OF NEUROPATHIC PAIN IN PATIENTS FROM NOTHERN TURKEY H. Turker, Y. Turkel, A.O. Bayrak, I. Demir, M. Onar. Neurology, Ondokuz Mayis University, Faculty of Medicine, Samsun, Turkey Introduction: S-LANSS score is a self-performed version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and was first validated and used by Bennett and co-workers. S-LANSS score provides identification of neuropathic pain without the help and need of a clinician and is practical for both the patient and the physician. Objectives: In this study we targeted validation of the S-LANSS score in the Turkish population. Methods: For the linguistic validation of S-LANSS, translation and back-translation method was used to adapt S-LANSS into Turkish and a cognitive-debriefing test was performed. A total of 150 patients who were referred to the outpatient clinics of Neurology Department of Ondokuz Mayis University were enrolled in the present study. LANSS, S-LANSS, VAS (Visual Annalogue Score) and NPQ (Neuropathic Pain Questionnaire) were performed twice (with 7 day intervals) for every patient, besides a thourogh clinical examination and electroneuromyographical examination and imaging studies where necessary. The patients were examined and diagnosed as having nociceptive or neuropathic pain by neurologists, who were blind for S-LANSS, LANSS and NPQ scores of the patients. Results: Results of the McNemar test indicated that S-LANSS scores were reliable when the first and the second scores were compared. The sensitivity and specificity of the scale were found to be 98% and 97% respectively, suggesting a high validity for the Turkish version of S-LANSS score. Conclusions: We believe that using S-LANSS scores for the diagnosis of neuropathic pain may help our colleagues as a tool for quicker differential diagnosis of pain in daily practice. 312 PREVALENCE AND RISK FACTORS OF PERIPHERAL NEUROPATIC PAIN IN PREDIABETES C. Voulgari, K. Makrilakis, A. Kokkinos, N. Tentolouris. 1st Department of Propaedeutic Medicine, Laiko General Hospital, Athens University Medical School, Athens, Greece Introduction: It is controversial whether there is a glycemic threshold above which peripheral neuropathic pain (PNP) develops and which are the most important factors associated with PNP in the general population. Objectives: The aim of this study was to determine the prevalence and risk factors of PNP in subjects with impaired fasting glucose (IFG) vs. normal fasting glucose (NFG). Methods: The study included 313 subjects (151 IFG/162 NFG) matched for age (57.6 ±9.9 years) and sex (162 males/150 females). Presence or absence of PNP was determined by the Michigan Neuropathy Screening Instrument (MNSI) using its pain-relevant
to a change in score of −1.64-points (95% confidence interval, −1.86 to −1.43). Results from subgroup analyses (≥30% or ≥50% pain responders, pregabalin or placebo treatment) were generally consistent with the results from the overall sample, suggesting robustness of findings. Conclusions: Changes in pain levels during treatment with pregabalin were associated with changes in sleep, function, anxiety, and depression. Additional confirmatory studies are encouraged. 309 PREGABALIN IN POST-TRAUMATIC PERIPHERAL NEUROPATHIC PAIN: EFFICIENT ASSESSMENT OF EFFICACY IN A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSSOVER STUDY T. Jenkins1 , T. Smart1 , F. Hackman1 , C. Cooke1 , K. Tan1 , R. Cheung2 . 1 Pfizer Global Research and Development, Sandwich, UK; 2 Pfizer, Inc, New York City, NY, USA Introduction: Pregabalin has demonstrated efficacy in several neuropathic pain states, including post-traumatic peripheral neuropathic pain (PTNP), in classic, parallel group trials. A crossover design may be a more efficient method to detect the efficacy of pregabalin. Objectives: To assess the ability of a two-period crossover study design to detect the efficacy of pregabalin in patients with PTNP. Methods: Twenty-five adults (20–70 years) with PTNP for ≥3 months and an average daily pain score ≥4 (0–10 scale) during 1-week single-blind, placebo run-in, were randomised to one of two treatment sequences of pregabalin 300 mg/day vs. placebo. Each treatment period was 2 weeks separated by a 2-week washout, during which patients received placebo. The primary endpoint was the average pain score over the last 7 days on treatment. A mixed effects analysis of covariance was fitted, accounting for period and treatment effects, random subject effect, and baseline incorporated as a covariate. Results: The mean baseline pain score was 6.0 for Period 1 and 5.3 for Period 2 in both sequences. The mean (90% CI) difference between pregabalin and placebo was −0.81 (−1.34, −0.28). The improvement with pregabalin was of similar magnitude to a larger parallel group study in PTNP. Pregabalin was well tolerated, with 2 discontinuations. Somnolence and dizziness were reported in 3 and 6 patients while on pregabalin treatment, respectively. Conclusions: This two-period crossover study detected treatment efficacy of pregabalin in PTNP with a sample size much smaller than parallel-group studies. Such study designs may be useful for proof-of-concept studies. 310 PREVALENCE AND RISK FACTORS FOR PERIPHERAL NEUROPATHIC PAIN IN PATIENTS WITH NEWLY DIAGNOSED TYPE 2 DIABETES N. Tentolouris, C. Voulgari, E. Diakoumopoulou, S. Liatis, K. Kyriakopoulos, N. Katsilambros. 1st Department of Propaedeutic Medicine, Laiko General Hospital, Athens University Medical School, Athens, Greece Introduction: Hyperglycemia is a major permissive factor for the development of diabetic neuropathy, but evidence has emerged suggesting that other factors play a paramount role for its pathogenesis and clinical phenotype. However, prevalence and risk factors for peripheral neuropathic pain (PNP) in patients with newly diagnosed type 2 diabetes (T2DM) are not known. Objectives: The aim of the present study was to determine the prevalence and risk factors for painful neuropathy among subjects with newly diagnosed T2DM without micro- or macrovascular complications. Methods: The study included 203 subjects (98 females/105 males, age 56.5±9.1 years) from the Diabetic Outpatient Clinics of our Hospital. Presence or absence of PNP was determined by the Michigan Neuropathy Screening Instrument (MNSI) using its painrelevant questions and an examination cutpoint >2. Ankle-brachial-
89
pressure-index (ABI) and left-ventricular-mass index (LVMi) were assessed by ultrasonography. Results: The prevalence of PNP was 31.0% in the studied population. Multivariate logistic regression analysis demonstrated that the odds (OR, 95% confidence intervals) of PNP increased with age [1.130 (1.034–1.235)], obesity [2.362 (1.534–3.608)], central fat distribution [1.867 (1.780–1.963)], high systolic blood pressure [1.008 (1.006– 1.118)], fasting glucose [1.012 (1.000–1.204)], and low ABI [1.047 (1.014–1.081)] (all P < 0.05). Additional variables included in the model were HbA1c, LDL-cholesterol, urinary albumin-excretionratio, and LVMi. Conclusions: PNP is common at the time of diagnosis of T2DM. Obesity, central fat distribution, high fasting glucose and peripheral arterial disease are associated with PNP. 311 VALIDATION OF S-LANSS SCORE FOR IDENTIFICATION OF NEUROPATHIC PAIN IN PATIENTS FROM NOTHERN TURKEY H. Turker, Y. Turkel, A.O. Bayrak, I. Demir, M. Onar. Neurology, Ondokuz Mayis University, Faculty of Medicine, Samsun, Turkey Introduction: S-LANSS score is a self-performed version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS) and was first validated and used by Bennett and co-workers. S-LANSS score provides identification of neuropathic pain without the help and need of a clinician and is practical for both the patient and the physician. Objectives: In this study we targeted validation of the S-LANSS score in the Turkish population. Methods: For the linguistic validation of S-LANSS, translation and back-translation method was used to adapt S-LANSS into Turkish and a cognitive-debriefing test was performed. A total of 150 patients who were referred to the outpatient clinics of Neurology Department of Ondokuz Mayis University were enrolled in the present study. LANSS, S-LANSS, VAS (Visual Annalogue Score) and NPQ (Neuropathic Pain Questionnaire) were performed twice (with 7 day intervals) for every patient, besides a thourogh clinical examination and electroneuromyographical examination and imaging studies where necessary. The patients were examined and diagnosed as having nociceptive or neuropathic pain by neurologists, who were blind for S-LANSS, LANSS and NPQ scores of the patients. Results: Results of the McNemar test indicated that S-LANSS scores were reliable when the first and the second scores were compared. The sensitivity and specificity of the scale were found to be 98% and 97% respectively, suggesting a high validity for the Turkish version of S-LANSS score. Conclusions: We believe that using S-LANSS scores for the diagnosis of neuropathic pain may help our colleagues as a tool for quicker differential diagnosis of pain in daily practice. 312 PREVALENCE AND RISK FACTORS OF PERIPHERAL NEUROPATIC PAIN IN PREDIABETES C. Voulgari, K. Makrilakis, A. Kokkinos, N. Tentolouris. 1st Department of Propaedeutic Medicine, Laiko General Hospital, Athens University Medical School, Athens, Greece Introduction: It is controversial whether there is a glycemic threshold above which peripheral neuropathic pain (PNP) develops and which are the most important factors associated with PNP in the general population. Objectives: The aim of this study was to determine the prevalence and risk factors of PNP in subjects with impaired fasting glucose (IFG) vs. normal fasting glucose (NFG). Methods: The study included 313 subjects (151 IFG/162 NFG) matched for age (57.6 ±9.9 years) and sex (162 males/150 females). Presence or absence of PNP was determined by the Michigan Neuropathy Screening Instrument (MNSI) using its pain-relevant