Computational protocol: [11C]-(R)-PK11195 positron emission tomography in patients with complex regional pain syndrome

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Protocol publication

[…] Fifteen patients who fulfilled the International Association for the Study of Pain criteria for CRPS type I were recruited from Seoul National University Hospital (Seoul, Republic of Korea) and United CRPS. Fifteen participants (recruited from an Internet advertisement) who were of comparable age and sex to the CRPS patients were enrolled in this study as healthy controls, and they had no pain or neurological-related symptoms. All participants underwent a detailed neuropsychiatric assessment completed through baseline screening that included a history of accidents, pain symptoms, routine blood analysis, electrocardiogram, and urine analysis. The number of study participants was based on a sample size calculation for a comparison of distribution volume ratio (DVR) between groups. Effect size was estimated from available PK11195 pilot study.[] In addition, we used G∗power 3.1.9.2 (Heinrich Heine, Universität Düsseldorf, Germany) program[] with unpaired t test, an 80% power while controlling type I error rate at 5%. The computed sample size was 11 subjects for each group, so we planned to recruit 15 subjects for each group considering potential withdrawal of subjects.The inclusion criteria for CRPS subjects were as follows: a diagnosis of CRPS type I, an age between 25 and 55 years, and patients who were not taking benzodiazepine or those who could stop the benzodiazepine medication 2 weeks before the study. All eligible patients were enrolled in the clinic and had the project research goals explained to them. The exclusion criteria were as follows: individuals with a major neuropsychiatric disorder before the diagnosis of CRPS, a neurological disease (cerebrovascular disease or brain tumor), a history of brain trauma, and high-sensitivity C-reactive protein (hs-CRP) or leukocytosis, as well as patients who could not undergo the PET/magnetic resonance imaging (MRI) process.The severity of neuropsychiatric symptoms (depressed mood, anxiety, suicidal tendencies, etc.) was measured in the CRPS patients using the following questionnaires: the Beck Depression Index (BDI),[] the Beck Anxiety Index (BAI),[] and Korean version of the Mood Disorder Questionnaire.[] Sensory and affective dimensions of current pain were assessed with the McGill pain Questionnaire Short-Form (SF-MPQ) which presents 11 McGill pain Questionnaire_Sensory and 4 McGill pain Questionnaire_Affective (MPQ_A) pain items.[] SF-MPQ also includes the present pain intensity index and a visual analog scale (VAS). We used subscales of SF-MPQ during analyses. Healthy controls were administered the BAI and BDI questionnaires.This study was approved by Institutional Review Board at Seoul National University Hospital (Seoul, Republic of Korea). All data were obtained under written informed consent granted by all subjects after a full explanation of the experimental methods. [...] Statistical analyses were performed using SPSS Statistics 21.0 (Chicago, IL). For all the variables, the normality of the distribution was tested with the Kolmogorov–Smirnov test. If normality was satisfied, differences between 2 groups were tested using the Student 2-tailed t test, and bivariate correlation was tested using Pearson correlation coefficient. If normality was not satisfied, Mann–Whitney U test and the Spearman rho correlation coefficient were used. Regional average DVR of [11C]-(R)-PK11195 were assessed using a Student 2-tailed t test. A Pearson correlation analysis was used to evaluated the association between the DVR of [11C]-(R)-PK11195 and the neuropsychiatric assessment scale and subdomain of SF-MPQ. The P value deemed to indicate significance was set at 0.05. […]

Pipeline specifications

Software tools G*Power, SPSS
Applications Miscellaneous, Magnetic resonance imaging
Organisms Homo sapiens